• Alprazolam (Oral Route)

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Description and Brand Names

Drug information provided by: Merative, Micromedex ®

US Brand Name

  • Gabazolamine-05

Canadian Brand Name

  • Alti-ALPRAZolam

Descriptions

Alprazolam is used to relieve symptoms of anxiety, including anxiety caused by depression. It is also used to treat panic disorder in some patients.

Alprazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet, Disintegrating
  • Tablet, Extended Release

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Label: XANAX- alprazolam tablet

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  • NDC (National Drug Code) - Each drug product is assigned this unique number which can be found on the drug's outer packaging." href="#" id="anch_dj_103">NDC Code(s): 0009-0029-01, 0009-0029-02, 0009-0029-14, 0009-0029-46, view more 0009-0055-01, 0009-0055-03, 0009-0055-15, 0009-0055-46, 0009-0090-01, 0009-0090-04, 0009-0090-13, 0009-0094-01, 0009-0094-03
  • Packager: PHARMACIA & UPJOHN COMPANY LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 18, 2023

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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See full prescribing information for complete boxed warning., recent major changes.

Warnings and Precautions ( 5.8 )                    1/2023

INDICATIONS AND USAGE

XANAX is a benzodiazepine indicated for the:

DOSAGE AND ADMINISTRATION

Dosage forms and strengths.

Tablets: 0.25 mg, 0.5 mg, 1 mg, and 2 mg ( 3 )

CONTRAINDICATIONS

Warnings and precautions, adverse reactions.

The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido. ( 6.1 )

To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Use in specific populations.

Lactation: Breastfeeding not recommended. ( 8.2 )

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2023

FULL PRESCRIBING INFORMATION: CONTENTS *

1 indications and usage, 2 dosage and administration, 2.1 dosage in generalized anxiety disorder, 2.2 dosage in panic disorder, 2.3 discontinuation or dosage reduction of xanax, 2.4 dosage recommendations in geriatric patients, 2.5 dosage recommendations in patients with hepatic impairment, 2.6 dosage modifications for drug interactions, 3 dosage forms and strengths, 4 contraindications, 5 warnings and precautions, 5.1 risks from concomitant use with opioids, 5.2 abuse, misuse, and addiction, 5.3 dependence and withdrawal reactions, 5.4 effects on driving and operating machinery, 5.5 interaction with drugs that inhibit metabolism via cytochrome p450 3a, 5.6 patients with depression, 5.8 neonatal sedation and withdrawal syndrome, 5.9 risk in patients with impaired respiratory function, 6 adverse reactions, 6.1 clinical trials experience, 6.2 postmarketing experience, 7 drug interactions, 7.1 drugs having clinically important interactions with xanax, 7.2 drug/laboratory test interactions, 8 use in specific populations, 8.1 pregnancy, 8.2 lactation, 8.4 pediatric use, 8.5 geriatric use, 8.6 hepatic impairment, 9 drug abuse and dependence, 9.1 controlled substance, 9.3 dependence, 10 overdosage, 11 description, 12 clinical pharmacology, 12.1 mechanism of action, 12.3 pharmacokinetics, 13 nonclinical toxicology, 13.1 carcinogenesis, mutagenesis, impairment of fertility, 13.2 animal toxicology and/or pharmacology, 14 clinical studies, 14.1 generalized anxiety disorder, 14.2 panic disorder, 16 how supplied/storage and handling, 17 patient counseling information.

XANAX is indicated for the:

The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses).

Use the lowest possible effective dose and frequently assess the need for continued treatment [see Warnings and Precautions (5.2) ] .

The recommended starting oral dosage of XANAX for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.

Controlled trials of XANAX in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day.

For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.

The necessary duration of treatment for PD in patients responding to XANAX is unknown. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see Dosage and Administration (2.3) ] .

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] .

Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled postmarketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

In geriatric patients, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see Use in Specific Populations (8.5) , Clinical Pharmacology (12.3) ] .

In patients with hepatic impairment, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .

XANAX should be reduced to half of the recommended dosage when a patient is started on ritonavir and XANAX together, or when ritonavir administered to a patient treated with XANAX. Increase the XANAX dosage to the target dose after 10 to 14 days of dosing ritonavir and XANAX together. It is not necessary to reduce XANAX dose in patients who have been taking ritonavir for more than 10 to 14 days.

XANAX is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see Contraindications (4) , Warnings and Precautions (5.5) ] .

XANAX tablets are available as:

XANAX is contraindicated in patients:

Concomitant use of benzodiazepines, including XANAX, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe XANAX concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of XANAX than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking XANAX, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when XANAX is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions (7.1) ] .

The use of benzodiazepines, including XANAX, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence (9.2) ] .

Before prescribing XANAX and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of XANAX, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of XANAX along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage (a patient-specific plan should be used to taper the dose) [see Dosage and Administration (2.3) ] .

Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.

Acute Withdrawal Reactions

The continued use of benzodiazepines, including XANAX, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of XANAX after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3) ] .

Protracted Withdrawal Syndrome

In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Drug Abuse and Dependence (9.3) ] .

Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure [see Drug Abuse and Dependence (9.3)] . Even after relatively short-term use at doses of ≤4 mg/day, there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients who received XANAX, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.

In a controlled clinical trial in which 63 patients were randomized to XANAX and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal.

Interdose Symptoms

Early morning anxiety and emergence of anxiety symptoms between doses of XANAX have been reported in patients with panic disorder taking prescribed maintenance doses. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound, or withdrawal symptoms over the entire course of the interdosing interval.

Because of its CNS depressant effects, patients receiving XANAX should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the concomitant use of alcohol and other CNS depressant drugs during treatment with XANAX [see Drug Interactions (7.1) ] .

The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam.

Strong CYP3A Inhibitors

XANAX is contraindicated in patients receiving strong inhibitors of CYP3A (such as azole antifungal agents), except ritonavir [see Contraindications (4) ] . Ketoconazole and itraconazole have been shown in vivo to increase plasma alprazolam concentrations 3.98 fold and 2.70 fold, respectively.

Dosage adjustment is necessary when XANAX and ritonavir are initiated concomitantly or when ritonavir is added to a stable dosage of XANAX [see Dosage and Administration (2.6) , Drug Interactions (7.1) ] .

Drugs demonstrated to be CYP3A inhibitors on the basis of clinical studies involving alprazolam: nefazodone, fluvoxamine, and cimetidine [see Drug Interaction (7.1) , Clinical Pharmacology (12.3) ] . Use caution and consider dose reduction of XANAX, as appropriate, during co-administration with these drugs.

Benzodiazepines may worsen depression. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Consequently, appropriate precautions (e.g., limiting the total prescription size and increased monitoring for suicidal ideation) should be considered in patients with depression.

Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression [see Adverse Reactions (6.2) ] .

Use of XANAX late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate [see Use in Specific Populations (8.1) ] . Monitor neonates exposed to XANAX during pregnancy or labor for signs of sedation and monitor neonates exposed to XANAX during pregnancy for signs of withdrawal; manage these neonates accordingly.

There have been reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with XANAX. Closely monitor patients with impaired respiratory function. If signs and symptoms of respiratory depression, hypoventilation, or apnea occur, discontinue XANAX.

The following clinically significant adverse reactions are described elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in:

In addition to the adverse reactions (i.e., greater than 1%) enumerated in the table above for patients with generalized anxiety disorder, the following adverse reactions have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

In addition to the reactions (i.e., greater than 1%) enumerated in the table above for patients with panic disorder, the following adverse reactions have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Adverse Reactions Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials

In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo-treated group are shown in Table 3.

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see Warning and Precautions (5.2) and Drug Abuse and Dependence (9.3) ] .

Paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations, and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.

The following adverse reactions have been identified during postapproval use of XANAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine disorders: Hyperprolactinemia

General disorders and administration site conditions: Edema peripheral

Hepatobiliary disorders: Hepatitis, hepatic failure

Investigations: Liver enzyme elevations

Psychiatric disorders: Hypomania, mania

Reproductive system and breast disorders: Gynecomastia, galactorrhea

Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome

Table 4 includes clinically significant drug interactions with XANAX [see Clinical Pharmacology (12.3) ] .

Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including XANAX, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/.

Risk Summary

Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) and Clinical Considerations) ] . Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/neonatal adverse reactions.

Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to XANAX during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to XANAX during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions (5.8) ] .

Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings.

Limited data from published literature reports the presence of alprazolam in human breast milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of alprazolam on lactation are unknown.

Because of the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with XANAX.

Safety and effectiveness of XANAX have not been established in pediatric patients.

XANAX-treated geriatric patients had higher plasma concentrations of alprazolam (due to reduced clearance) compared to younger adult patients receiving the same doses. Therefore, dosage reduction of XANAX is recommended in geriatric patients [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] .

Patients with alcoholic liver disease exhibit a longer elimination half-life (19.7 hours), compared to healthy subjects (11.4 hours). This may be caused by decreased clearance of alprazolam in patients with alcoholic liver disease. Dosage reduction of XANAX is recommended in patients with hepatic impairment [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ] .

XANAX contains alprazolam, which is a Schedule IV controlled substance.

XANAX is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see Warnings and Precautions (5.2) ] .

The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

XANAX may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see Warnings and Precautions (5.3) ] .

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage [see Dosage and Administration (2.3) , Warnings and Precautions (5.3) ] .

Acute Withdrawal Signs and Symptoms

Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.

Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.

Tolerance to XANAX may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of XANAX may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions (5.2) ] . Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information.

Consider contacting the Poison Help Line (1-800-222-1222), or a medical toxicologist for additional overdosage management recommendations.

XANAX contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.

The structural formula is:

alprazolam structural formula

Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.

Each XANAX tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam.

Inactive ingredients: cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.

Alprazolam is a 1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety disorder and panic disorder through binding to the benzodiazepine site of gamma‑aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.

Plasma levels of alprazolam increase proportionally to the dose over the range of 0.5 to 3.0 mg.

Following oral administration, peak plasma concentration of alprazolam (C max ) occurs in 1 to 2 hours post dose.

Distribution

Alprazolam is 80% bound to human serum protein, and albumin accounts for the majority of the binding.

Elimination

The mean plasma elimination half-life (T 1/2 ) of alprazolam is approximately 11.2 hours (range: 6.3 to 26.9 hours) in healthy adults.

Alprazolam is extensively metabolized in humans, primarily by cytochrome P450 3A4 (CYP3A4), to 2 major active metabolites in the plasma: 4-hydroxyalprazolam and α-hydroxyalprazolam. The plasma circulation levels of the two active metabolites are less than 4% of the parent. The reported relative potencies in benzodiazepine receptor binding experiments and in animal models of induced seizure inhibition are 0.20 and 0.66, respectively, for 4-hydroxyalprazolam and α-hydroxyalprazolam. The low concentrations and low potencies of 4-hydroxyalprazolam and α-hydroxyalprazolam indicate that they unlikely contribute much to the effects of alprazolam. A benzophenone derived from alprazolam is also found in humans. Their half-lives appear to be similar to that of alprazolam.

Alprazolam and its metabolites are excreted primarily in the urine.

Specific Populations

Geriatric patients.

The mean T 1/2 of alprazolam was 16.3 hours (range: 9.0 to 26.9 hours) in healthy elderly subjects compared to 11.0 hours (range: 6.3 to -15.8 hours, n=16) in healthy younger adult subjects.

Obese Patients

The mean T 1/2 of alprazolam was 21.8 hours (range: 9.9 to 40.4 hours) in a group of obese subjects.

Patients with Hepatic Impairment

The mean T 1/2 of alprazolam was 19.7 hours (range: 5.8 to 65.3 hours) in patients with alcoholic liver disease.

Racial or Ethnic Groups

Maximal concentrations and T 1/2 of alprazolam are approximately 15% and 25% higher in Asians compared to Caucasians.

Alprazolam concentrations may be reduced by up to 50% in smokers compared to non-smokers.

Drug Interaction Studies

In vivo studies.

Most of the interactions that have been documented with alprazolam are with drugs that modulate CYP3A4 activity.

Compounds that are inhibitors or inducers of CYP3A would be expected to increase or decrease plasma alprazolam concentrations, respectively. Drug products that have been studied in vivo, along with their effect on increasing alprazolam AUC, are as follows: ketoconazole, 3.98 fold; itraconazole, 2.66 fold; nefazodone, 1.98 fold; fluvoxamine, 1.96 fold; and erythromycin, 1.61 fold [see Contraindications (4) , Warnings and Precautions (5.5) , Drug Interactions (7.2) ] . Other studied drugs include:

Cimetidine: Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 82%, decreased clearance by 42%, and increased T 1/2 by 16%.

Fluoxetine: Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased T 1/2 by 17%, and decreased measured psychomotor performance.

Oral Contraceptives: Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased T 1/2 by 29%.

Carbamazepine: The oral clearance of alprazolam (given in a 0.8 mg single dose) was increased from 0.90±0.21 mL/min/kg to 2.13±0.54 mL/min/kg and the elimination T 1/2 was shortened (from 17.1±4.9 to 7.7±1.7 hour) following administration of 300 mg per day carbamazepine for 10 days [see Drug Interactions (7.2) ] . However, the carbamazepine dose used in this study was fairly low compared to the recommended doses (1000-1200 mg per day); the effect at usual carbamazepine doses is unknown.

Ritonavir: Interactions involving HIV protease inhibitors (e.g., ritonavir) and alprazolam are complex and time dependent. Short-term low doses of ritonavir (4 doses of 200 mg) increased mean AUC of alprazolam by about 2.5-fold, and did not significantly affect C max of alprazolam. The elimination T 1/2 was prolonged (30 hours versus 13 hours). However, upon extended exposure to ritonavir (500 mg, twice daily for 10 days), CYP3A induction offset this inhibition. Alprazolam AUC and C max was reduced by 12% and 16%, respectively, in the presence of ritonavir. The elimination T 1/2 of alprazolam was not significantly changed [see Warnings and Precautions (5.5) ] .

Sertraline: A single dose of alprazolam 1 mg and steady state dose of sertraline (50 mg to 150 mg per day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam.

Imipramine and Desipramine: The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of XANAX in doses up to 4 mg per day.

Warfarin: Alprazolam did not affect the prothrombin or plasma warfarin levels in male volunteers administered sodium warfarin orally.

In Vitro Studies

Data from in vitro studies of alprazolam suggest a possible drug interaction of alprazolam with paroxetine. The ability of alprazolam to induce human hepatic enzyme systems has not yet been determined.

Carcinogenesis

No evidence of carcinogenic potential was observed in rats or mice administered alprazolam for 2 years at doses up to 30 and 10 mg/kg day respectively. These doses are 29 times and 4.8 times the maximum recommended human dose of 10 mg/day based on mg/m 2 body surface area, respectively.

Mutagenesis

Alprazolam was negative in the in vitro Ames bacterial reverse mutation assay and DNA Damage/Alkaline Elution Assay and in vivo rat micronucleus genetic toxicology assays.

Impairment of Fertility

Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg per day, which is approximately 5 times the maximum recommended human dose of 10 mg per day based on mg/m 2 body surface area.

When rats were treated with alprazolam at oral doses of 3 mg, 10 mg, and 30 mg/kg day (3 to 29 times the maximum recommended human dose based on mg/m 2 body surface area) for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

XANAX was compared to placebo in double-blind clinical studies (doses up to 4 mg per day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. XANAX was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s Global Impressions, and Self-Rating Symptom Scale.

The effectiveness of XANAX in the treatment of panic disorder was studied in 3 short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.

The average dose of XANAX was 5 mg to 6 mg per day in 2 of the studies, and the doses of XANAX were fixed at 2 mg and 6 mg per day in the third study. In all 3 studies, XANAX was superior to placebo on a variable defined as “the number of patients with zero panic attacks” (range, 37% to 83% met this criterion), as well as on a global improvement score. In 2 of the 3 studies, XANAX was superior to placebo on a variable defined as “change from baseline on the number of panic attacks per week” (range, 3.3 to 5.2), and also on a phobia rating scale. A subgroup of patients who improved on XANAX during short-term treatment in 1 of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.

XANAX is supplied in the following strengths and package configurations:

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).

Risks from Concomitant Use with Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] .

Abuse, Misuse, and Addiction

Inform patients that the use of XANAX, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2) , Drug Abuse and Dependence (9.2) ] .

Withdrawal Reactions

Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of XANAX may require a slow taper [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] .

Effects on Driving and Operating Machinery

Advise patients not to drive a motor vehicle or operate heavy machinery while taking XANAX due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking XANAX [see Warnings and Precautions (5.3) ] .

Patients with Depression

Advise patients, their families, and caregivers to look for signs of suicidality or worsening depression, and to inform the patient’s healthcare provider immediately [see Warnings and Precautions (5.6) ] .

Concomitant Medications

Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7) ] .

Advise pregnant females that use of XANAX late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns [see Warnings and Precautions (5.8) , Use in Specific Populations (8.1) ] . Instruct patients to inform their healthcare provider if they are pregnant.

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX during pregnancy [see Use in Specific Populations (8.1) ] .

Advise patients that breastfeeding is not recommended during treatment with XANAX [see Use in Specific Populations (8.2) ] .

Distributed by: Viatris Specialty LLC Morgantown, WV 26505   U.S.A.

UPJ:XNXT:RX2

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 1/2023

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0009-0029-01

alprazolam tablets, USP

100 Tablets        Rx only

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

Protect from light.

Dispense in tight (USP), light-resistant, child-resistant containers.

DOSAGE AND USE: See accompanying prescribing information.

Each tablet contains 0.25 mg alprazolam.

Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017

Xanax 0.25 mg product label

NDC 0009-0055-01

Each tablet contains 0.5 mg alprazolam.

Xanax 0.5 mg product label

NDC 0009-0090-01

Each tablet contains 1 mg alprazolam.

Xanax 1 mg product label

NDC 0009-0094-01

Each tablet contains 2 mg alprazolam.

Xanax 2 mg product label

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Art of Presentations

Does Taking Xanax Help Before a Presentation? Is it Safe!

By: Author Shrot Katewa

Does Taking Xanax Help Before a Presentation? Is it Safe!

You might have heard that taking Xanax is an effective way to reduce anxiety before a presentation. However, you might also be wondering if it is safe to take or whether it will even work for you!

Xanax resolves the chemical imbalances in the brain which can make giving a presentation less stressful. It is an effective drug designed to reduce the effects of Social Anxiety Disorder (SAD) and panic attacks. However, there are a number of side effects, including addiction, which should be considered.

You should always consult a doctor before using Xanax or any other Benzodiazepines. However, here’s a brief guide to help you understand how they can help, along with their associated risks.

What is Xanax?

Xanax: Can It Kill You? -

Xanax is a drug used to help in suppressing the nervousness and anxiousness caused by a number of social disorders. The name ‘Xanax’ is, in fact, just a brand name for the drug – which is officially called ‘ alprazolam ’, which is a member of the benzodiazepine family.

It is the single most prescribed psychiatric drug in the US; and for many it has been a safe and effective means of overcoming psychological issues from Social Anxiety Disorder (SAD) through to panic attacks.

Other names for the drug include:

  • Blue Footballs

How Does Xanax help to Cope with Stressful Situations?

Tired stressed male worker taking off glasses, person massaging nose bridge suffering from headache and trying to relieve pain. Despaired man frustrated after reading company collapse or failure news

Simply speaking, Xanax helps by reducing the levels of stress you feel as a result of a given social situation – which might include giving a presentation. This means that for many people they are an effective way of chemically coping with the stresses associated with public speaking.

According to the National Social Anxiety Center , 73% of people in the world experience some form of glossophobia (the fear of public speaking sometimes called SAD). Given this stat, it is no surprise that Xanax is used by professionals the world over to mentally prepare for a stressful presentation.

Xanax is particularly effective, in the case of giving presentations, as it dulls the fear of judgment from others. This is one of the main factors causing stress among people giving presentations. As such, a person giving a presentation on Xanax is more likely to come across as confident and certain about what they are saying.

That said, Xanax will not eliminate all anxious feeling forever. It simply reduces the feelings for the duration in which the drug is taken and only maintains an effect on your body for a short period. This is typically between four and six hours, depending on an individual’s dose and other physiological factors.

How Does Xanax Work?

Xanax works by binding to Gamma-Amino Butyric Acid (GABA) receptors in your brain. These are neurotransmitters, which are supposed to help regulate the levels of neural excitability – such as nervousness and anxiousness.

Obviously, as with any chemical reaction within our bodies, some people produce more GABA than others. Therefore, those who produce less are more susceptible to stress and anxiety because their body has less capacity to regulate such feelings.

By binding to the GABAs, Xanax slows down the neural activity associated with such negative feelings . This leaves the person who takes them feeling calmer, more relaxed and, in some cases, sleepy.

Xanax is typically prescribed by doctors for a period of 8 weeks , however, most people do not find it hard to have the pills re-prescribed for another cycle after this period comes to an end.

What are the Risks of Using Xanax Frequently?

As with any medical procedure, no matter if it is having an operation or taking a pill (as in the case of Xanax) there will inevitably be an associated risk. After all, you are fundamentally altering your body’s chemical balance, which will have knock-on effects beyond those that you might wish, and which might lead to a negative outcome.

The risks included in taking Xanax are numerous. As a result, you should not take Xanax if you are any of the following:

  • Pregnant or Nursing
  • Taking Birth Control Pills, Antihistamines, Anticonvulsants or other psychotropic medications.
  • Allergic to Benzodiazepines
  • Are also taking itraconazole (Sporanox) or ketoconazole (Nizoral)

It is also very important that you do not drink while you are taking Xanax. This is a particular problem in the world of business, where someone might take a Xanax to give a presentation at a conference and then head to the bar afterwards to network and socialise with colleagues.

Furthermore, as per a research report by the National Centre for Biotechnology Information – U.S National Library of Medicine , it was observed that Xanax has a greater effect on people with Asian heritage than those of other races. Research suggests that they are more likely to ‘feel high’ and experience a spike in blood pressure as a result of taking the drug when compared to their white counterparts.

Therefore, you should consult a doctor before taking Xanax; and you should seek emergency medical help if you notice any adverse effects of taking it.

Side-effects of Xanax

Xanax overdose: Symptoms, dangers, and what to do

While Xanax can be a safe and useful means of coping with the stresses of daily life for some, it can be the cause of a number of unwanted side-effects. In some cases, these can come as a result of taking too much of the drug, but it is also important to remember that some people react negatively to the drug even if taking the correct dosage.

The most common side effects of taking Xanax is drowsiness . For this reason, you should not drive or operate heavy machinery while you are on the medication. That said, this is one of the less serious side effects caused by Xanax. Especially in circumstances where a user takes an overdose , there can be much more severe, dangerous and long-lasting effects associated with the drug.

For example, an overdose of Xanax can cause; fainting, loss of balance, muscle weakness, slowed heart rate, confusion and, in some cases, it can even induce a coma. 

Can you Get Addicted to Xanax?

Xanax Withdrawal: Symptoms, Timeline & Treatment

Addiction is a serious concern when it comes to the taking of Xanax for simple cases of social anxiety. The American Addiction Center cites an interesting stat captured from the Journal of Addictive Behaviours which estimates that as many as 44% of ‘chronic benzodiazepine’ users become addicted !

One reason for this level of addiction is that the brain becomes accustomed to the relaxed state associated with the drug. If a user returns to a normal level of stress, without access to the drug, this can feel overwhelming. This results in an even greater level of anxiety than was experienced in the first place, and therefore a certain level of dependency on the drug.

Addiction to Xanax does not only come in a psychological sense. Many people who become dependent on the drug develop a physical dependency, which include; shortness of breath, vomiting and seizures. Benzodiazepines, including Xanax, were the primary reason for more than 44,000 visits to the emergency room in US hospitals in 2011.

As mentioned above, taking any drug induces chemical alterations to your body which may have long-lasting negative effects on your body. This is why you should consult a doctor before taking the drug and should explore other, non-chemical alternatives where possible.

Whar are the Alternatives to Xanax?

A handsome man wearing a suit and a tie meditating on the floor

While the use of Xanax is not problematic for many people, you may wish to eliminate any possibility of severe medical problems by exploring alternatives methods for controlling your anxiety in the lead up to a presentation.

One of the first things to consider is your diet. It might sound convoluted to suggest that what you eat might have a significant impact on your ability to calmly and confidently give a presentation, however, the research suggests that diet might be one of the most effective ways to reduce stress .

Research shows that by simply consuming basic nutrients such as Omega 3 and Vitamin E , you can reduce your blood pressure. This means that blood flows more freely to your brain, which will impact the production of those chemicals which result in a more positive mindset.

What’s more, if you are healthier, you are more likely to feel confident in how you look. Therefore, the combined boost of feeling and looking great will reduce your levels of anxiety when it comes to giving your presentation.

That said, changing your diet could be seen to be a more long-term fix. What if you have a presentation next week? Well, two of the simplest ways to reduce anxiety in the short term is to have a good night’s sleep in the build-up to your presentation.

A lack of sleep can make you more emotionally reactive, more responsive to negative emotion and impulsive – all of which are key reasons for taking Xanax in the first place. Therefore, while it may be a useful drug in dealing with your anxiety, there are a number of alternative methods for achieving the same goal, which do not require you to consume Xanax or any other Benzodiazepine.  

Disclaimer: This blog provides general information and discussions about health and related subjects. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment. If you or any other person has a medical concern, you should consult with your health care provider or seek other professional medical treatment. Never disregard professional medical advice or delay in seeking it because of something that have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately. The opinions and views expressed on this blog and website have no relation to those of any academic, hospital, health practice or other institution.

Xanax: 7 things you should know

Medically reviewed by Carmen Pope, BPharm . Last updated on Aug 29, 2023.

1. How it works

  • Xanax is a brand (trade) name for alprazolam. Alprazolam may be used in the treatment of anxiety and other mood-type disorders. It may also be given for its calming and sedative properties.
  • Experts aren't sure exactly how Xanax works to stabilize mood but experts suggest it may enhance the activity of GABA (gamma-aminobutyric acid), an inhibitory neurotransmitter, in the brain. This produces hypnosis (a trancelike state).
  • Xanax belongs to the class of medicines known as benzodiazepines.
  • May be used to help manage the symptoms of generalized anxiety disorder or for the short-term relief of symptoms of anxiety. May help the symptoms of anxiety associated with depression.
  • May be used for the treatment of panic disorder, with or without agoraphobia (agoraphobia is a fear of places or situations that might cause panic, helplessness, or embarrassment).
  • Xanax is available as an immediate-release tablet and an extended-release tablet.
  • Available in four strengths: 0.25mg, 0.5mg, 1mg, and 2mg.
  • Xanax is available as a generic under the name alprazolam.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Drowsiness and unsteadiness upon standing, increasing the risk of falls.
  • May impair reaction skills and affect a person's ability to drive or operate machinery. Avoid alcohol.
  • Blood pressure-lowering, heart palpitations, constipation, nausea, dry mouth, headache, and a decrease in libido are also commonly reported side effects.
  • Xanax is potentially addictive and may cause emotional or physical dependence that may lead to overdose or death. Before prescribing Xanax assess a person's risk for abuse, misuse, and addiction.
  • Withdrawal symptoms (including convulsions, tremors, cramps, vomiting, sweating, or insomnia) may occur with abrupt discontinuation; taper off slowly over several months under a doctor's supervision.
  • Smokers may have less of a response to Xanax. The dosage of Xanax may need to be reduced in those with liver disease.
  • Although Xanax has been used off-label (not an FDA-approved use but still a common use) in the past to aid sleep, it should not be promoted for this purpose unless there is no other alternative. Benzodiazepines such as Xanax reduce the duration of deep or slow-wave sleep, (which correlates to how refreshed you feel in the morning) and are also associated with addiction, dependence, and tolerances (where progressively larger dosages of the same drug are needed to obtain the same effect). Abrupt discontinuation of Xanax, when used for sleep, has been associated with rebound insomnia that may be worse than the initial sleeping problem.
  • Avoid combining Xanax with other benzodiazepines (such as diazepam) or opioids such as oxycodone or hydrocodone. Profound sedation, respiratory depression (abnormally slow and shallow breathing), coma, and death may result. May also interact with several other drugs including those that induce or inhibit CYP 3A hepatic enzymes. Do not use it in people taking strong CYP3A inhibitors such as ketoconazole or itraconazole. There have been reports of death in people with severe pulmonary disease given Xanax.
  • May worsen depression in some people. Monitor.
  • Needs to be given several times a day. The recommended initial dosage is 0.5mg three times daily.
  • May not be suitable for people with significant liver or kidney disease, lung disease or breathing problems, and certain psychiatric disorders.
  • If Xanax is given to pregnant women during the later stages of pregnancy, sedation, respiratory depression, lethargy, hypotonia, and withdrawal symptoms may occur in the newborn. Avoid unless the benefits outweigh the risks and observe the infant when born.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Xanax may be used for the treatment of anxiety or panic disorder; however, it is addictive, and withdrawal symptoms can be severe. Can interact with several drugs including those that cause drowsiness or induce or inhibit CYP 3A hepatic enzymes. May not be suitable for people with severe pulmonary disease.

  • Xanax may be taken with or without food.
  • Avoid operating machinery, driving, or performing tasks that require mental alertness while taking Xanax.
  • Avoid alcohol while taking this medicine.
  • The lowest effective dose of Xanax should be used for the shortest time possible.
  • Extended-release tablets should be taken in the morning, swallowed whole, and not crushed or chewed.
  • Withdrawal symptoms (blurred vision, insomnia, sweating, and rarely seizures) may occur if long-term Xanax is stopped abruptly; discontinue slowly on a doctor's advice.
  • Not for use if you have acute narrow-angle glaucoma.
  • Do not take Xanax with itraconazole (Sporanox) or ketoconazole (Nizoral) or take it with any other medications until you have checked with your doctor that they are compatible with Xanax.
  • Keep out of reach of children and pets.
  • Do not start or discontinue Xanax during pregnancy without speaking to your provider first.
  • Do not use during pregnancy except on a doctor's advice and women should not breastfeed their baby while receiving Xanax.
  • Talk to your doctor or pharmacist before taking other medications with Xanax to check that they are compatible with them.

6. Response and effectiveness

  • Peak concentrations of Xanax occur 1-2 hours following administration of immediate-release tablets, and up to 12 hours following administration of extended-release forms.
  • The duration of the effect of Xanax varies between individuals and formulations (anywhere from 6 to 27 hours).

7. Interactions

Medicines that interact with Xanax may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Xanax. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Xanax include:

  • anti-anxiety medications, including other benzodiazepines, such as lorazepam and oxazepam
  • anticonvulsants such as valproate
  • antidepressants, such as amitriptyline, imipramine, nortriptyline
  • antifungals such as voriconazole
  • antihistamines that cause sedation, such as diphenhydramine
  • barbiturates
  • HIV medications such as ritonavir (reduce the dosage of Xanax to half of that recommended, then increase to the target dosage after 10 to 14 days)
  • monoamine oxidase inhibitors, such as selegiline, isocarboxazid, or phenelzine
  • opioid analgesics such as alfentanil, codeine, oxycodone and morphine
  • oral contraceptives
  • muscle relaxants such as baclofen and cyclobenzaprine
  • scopolamine
  • sleeping pills, such as zolpidem
  • some medications used to treat mental illness, such as clozapine and thioridazine
  • strong CYP3A inhibitors, such as ketoconazole and itraconazole (do not use together)
  • Other CYP3A inhibitors, such as ritonavir, nefazodone, fluvoxamine, or cimetidine (consider dosage reduction of Xanax)
  • theophylline.

Alcohol may worsen the side effects of Xanax such as drowsiness and dizziness.

Note that this list is not all-inclusive and includes only common medications that may interact with Xanax. You should refer to the prescribing information for Xanax for a complete list of interactions.

More about Xanax (alprazolam)

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  • Xanax (alprazolam) [Package Insert]. Revised 01/2023. Pharmacia and Upjohn Company LLC. https://www.drugs.com/pro/xanax.html

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xanax only for the indication prescribed.

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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StatPearls [Internet].

Benzodiazepine toxicity.

Michael Kang ; Michael A. Galuska ; Sassan Ghassemzadeh .

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Last Update: June 26, 2023 .

  • Continuing Education Activity

Since the 1960s, with the development of chlordiazepoxide and shortly thereafter diazepam, benzodiazepines quickly became popular medications secondary to their vastly superior safety profiles when compared to previous sedative-hypnotics such as barbiturates and other non-barbiturates used for the treatment of anxiety and insomnia. Since their initial development, multiple benzodiazepine drugs have been developed over the course of several decades. Benzodiazepines are currently used to treat anxiety, seizures, withdrawal states, insomnia, agitation, and are commonly used for procedural sedation. Due to their many uses and addictive properties, benzodiazepines have been widely prescribed and abused since their development several decades ago. This activity reviews the pathophysiology, presentation, and etiology of benzodiazepine toxicity and highlights the role of the interprofessional team in the management of these patients.

  • Identify the epidemiology of benzodiazepine toxicity.
  • Review the presentation of a patient with benzodiazepine toxicity.
  • Outline the treatment and management options available for benzodiazepine toxicity.
  • Summarize interprofessional team strategies for improving care coordination and communication to advance the treatment of benzodiazepine toxicity and improve outcomes.
  • Introduction

Since the 1960s, with the development of chlordiazepoxide and shortly thereafter diazepam, benzodiazepines quickly became popular medications secondary to their vastly superior safety profiles when compared to previous sedative-hypnotics such as barbiturates and other non-barbiturates used for the treatment of anxiety and insomnia. Since their initial development, multiple benzodiazepine drugs have been developed over the course of several decades. Benzodiazepines are currently used to treat anxiety, seizures, withdrawal states, insomnia, agitation and are commonly used for procedural sedation. Due to their many uses and addictive properties, benzodiazepines have been widely prescribed and abused since their development several decades ago. Today, there are over 50 different agents available on the worldwide market, and the high incidence of benzodiazepine overdose mirrors their widespread use and availability. [1] [2] [3]

Leo Sternbach was an Austrian scientist working for Hoffmann-La Roche in Nutley, NJ, and has been accredited for his work in developing many drugs, in particular, benzodiazepines. In 1956, he serendipitously created chlordiazepoxide, which was approved for medical use in 1960. He later developed an improved, safer version named diazepam in 1963. Diazepam became widely popular, and between 1969 and 1982, it was the most prescribed drug in the United States, with over 2.3 billion doses sold in its peak year in 1978. [4]

  • Epidemiology

While precise data is unavailable, estimates suggest a lifetime prevalence of benzodiazepine use disorder to be less than 1%. Benzodiazepines, though, are often combined with other drugs. Thus the prevalence of an isolated benzodiazepine use disorder is difficult to determine from epidemiologic studies. Existing data suggest that the lifetime prevalence of tranquilizer and sedative use, which includes benzodiazepines and barbiturates in the United States, are around 1% and 1.1%, respectively. In 2013, 2% of the United States population (12 years or older) had consumed benzodiazepines or barbiturates for nonmedical use. From 1996 to 2013, benzodiazepine prescriptions increased by 2.5% each year, making it one of the most prescribed medications in the world. Substance abuse disorder treatment centers reported admissions for benzodiazepine abuse as the sole primary substance or drug of choice to have increased by 109% between 2003 and 2013.

  • Pathophysiology

Benzodiazepines are organic bases with a benzene ring and a 7-member diazepine moiety, with variable side chains that determine the potency, duration of action, metabolite activity, and rate of elimination. Benzodiazepines exert their effect via modulation of the gamma-aminobutyric acid A (GABA-A) receptor, the primary inhibitory neurotransmitter in the central nervous system. The GABA-A receptor, depending on various arrangements of its subunits, determines its affinity for various agents that bind to the receptor. Benzodiazepines bind at the interface of the GABA-A receptor and subsequently lock the receptor into a configuration that increases its affinity for GABA. Benzodiazepines do not alter the production, release, or metabolism of GABA but instead potentiates its inhibitory actions by augmenting or enhancing receptor binding. This binding ultimately increases the flow of chloride ions through the GABA ion channel, causing postsynaptic hyperpolarization, which decreases the ability to generate an action potential. The low incidence of respiratory depression with benzodiazepines, which differentiates it from barbiturates, is related to the low density of binding sites in the brainstem, which houses the respiratory center. [5]

  • Toxicokinetics

Benzodiazepines taken in toxic doses without other coingestants rarely cause a significant toxidrome. The classic presentation in patients with isolated benzodiazepine overdose will include central nervous system (CNS) depression with normal or near-normal vital signs. Many patients will still be arousable and even provide a reliable history. Classic symptoms include slurred speech, ataxia, and altered mental status. Respiratory compromise is uncommon in isolated benzodiazepine ingestions, but if taken with coingestants such as ethanol or other drugs/medications, respiratory depression can be noted. It is important to note that most intentional ingestions of benzodiazepines do involve coingestants, the most common being ethanol, leading to substantial respiratory depression and airway compromise. The dose required to produce respiratory compromise is difficult to quantify and depends on multiple factors, including dosage, tolerance, weight, age, coingestants, and even genetics. Patients with severe toxicity will present in a stuporous or comatose state, and immediate airway management and mechanical ventilation may be required.

A unique toxidrome related to parenteral formulations of diazepam and lorazepam is propylene glycol poisoning. Propylene glycol is the diluent used in the parenteral formulations for these two benzodiazepines, and prolonged use can cause propylene glycol toxicity, which includes skin and soft tissue necrosis, hemolysis, cardiac dysrhythmias, hypotension, significant lactic acidosis, seizure, and multisystem organ failure. While propylene glycol toxicity is rare, it must be considered when patients are receiving large or continuous infusions of parenteral benzodiazepines, for example, when treating severe sedative or ethanol withdrawal syndromes such as delirium tremens.

  • History and Physical

Patients with benzodiazepine toxicity will primarily present with central nervous system depression ranging from mild drowsiness to a coma-like, stuporous state. The classic presentation of an isolated benzodiazepine overdose consists of CNS depression with normal vital signs. Cardiac-related effects and fatalities are rare in pure benzodiazepine toxicities. Respiratory depression or compromise, while less common when compared to barbiturates, is the most important adverse effect requiring immediate intervention. Life-threatening respiratory depression can be seen with large oral ingestions with or without coingestants. Iatrogenic causes of toxicity can be seen when benzodiazepines are combined with other drugs during procedural sedation, particularly with opiates such as fentanyl.

In children with benzodiazepine toxicity, most will have symptoms within four hours of ingestion. Ataxia is the most common sign of toxicity in children, occurring in 90% of pediatric patients. Respiratory compromise occurs in less than 10% of pediatric cases, and hypotension has not been reported.

Benzodiazepine overdose is usually suspected or diagnosed based on clinical presentation. Many patients are arousable and can provide supporting information regarding their ingestion. In the acutely poisoned patient who cannot provide an adequate history, a general approach should be undertaken to stabilize the patient. [6]

Before any diagnostic tests are ordered in the patient presenting with altered mental status with suspected overdose or toxicity, any respiratory or abnormal vital signs should be addressed first. Mechanical ventilation may be required to address respiratory compromise and intravenous fluids administered to manage hemodynamic instability.

In terms of general diagnostic testing, routine testing for the acutely poisoned patient should include a point of care glucose to immediately rule out and address hypoglycemia as the cause of altered mental status. Acetaminophen and aspirin levels, along with ethanol levels, should be ordered to evaluate for possible coingestions. An ECG should be ordered to rule out the ingestion of drugs that may widen the QRS or QTc intervals and may precipitate arrhythmias. A pregnancy test should be ordered for all women of childbearing age. A head CT without contrast may be considered to rule out an intracranial abnormality related to the patient presenting with an acutely altered mental status.

While a standard urine drug screen (UDS) should be ordered, it comes with many limitations. Qualitative immunoassays for benzodiazepines in urine are readily available but do not typically aid in acute management decisions. Most of these screening tests detect only benzodiazepines that are metabolized to oxazepam glucuronide. Some benzodiazepines such as clonazepam, lorazepam, midazolam, and alprazolam will not show up on many urine drug screens as a result. A positive urine drug screen only indicates recent exposure but does not confirm causality for acute toxicity or overdose, nor does it name a specific agent.

  • Treatment / Management

The mainstay treatment for acute benzodiazepine toxicity is supportive care, which may include endotracheal intubation to provide definitive airway management. Single-dose or multi-dose activated charcoal, hemodialysis, or whole bowel irrigation play no role in managing benzodiazepine toxicity.

While the mainstay treatment of acute benzodiazepine toxicity or overdose is supportive care, there is, however, an “antidote” that may be used in limited situations. Flumazenil is a nonspecific competitive antagonist at the benzodiazepine receptor that can reverse benzodiazepine-induced sedation. However, in most cases, the risks of flumazenil usually outweigh the benefits in acute toxicity, and thus flumazenil is not recommended for routine reversal of this sedative agent. Seizures and cardiac dysrhythmias, particularly PSVT, can occur after flumazenil administration, and many fatalities have been reported. Flumazenil can precipitate acute withdrawal syndromes in those with chronic benzodiazepine dependence, which can be life-threatening. If a patient with a chronic dependence on benzodiazepines is given flumazenil, it can lower their seizure threshold and potentially cause life-threatening seizures. The treatment of seizures, which typically involves benzodiazepines, would be rendered useless, as the flumazenil has blocked the benzodiazepine receptors.

Flumazenil can be safely administered to non-habituated users of benzodiazepines. This situation classically occurs in the pediatric population with accidental ingestion or after procedural sedation. It is recommended that the decision to use flumazenil be based on the balance of risk versus benefit in the assessment and treatment of a patient that is a non-habituated user of benzodiazepines, as most people with a benzodiazepine overdose will do well with supportive care and time alone. [7] [8] [9]

  • Differential Diagnosis

The differential diagnosis of benzodiazepine toxicity includes:

  • Alcohol toxicity
  • Hypoglycemia
  • Hyponatremia or hypernatremia
  • Opiate toxicity

The prognosis depends on how quickly the diagnosis is made and the treatment administered.

  • Complications

The complications of benzodiazepine toxicity include:

  • Respiratory arrest
  • Aspiration pneumonitis
  • Rhabdomyolysis
  • Deterrence and Patient Education

The patients using benzodiazepines as recreational drugs should undergo psychological counseling and appropriate deaddiction therapy.

  • Enhancing Healthcare Team Outcomes

The key to preventing benzodiazepine toxicity is the education of the healthcare worker about sound prescribing habits. Many cases of benzodiazepine overdose have occurred because high doses of the drugs have been prescribed for trivial complaints. The nurse and the pharmacist should also educate the patient on drug safety. The patient should be told to abstain from alcohol and illicit drugs while taking benzodiazepines. Further, any patient with an intentional overdose should be referred to a mental health counselor prior to discharge. The pharmacist must always check the database to ensure that the patient is not obtaining multiple prescriptions from other pharmacies. Medical providers and pharmacists must always be suspicious of patients who present with stories of lost prescriptions or repeat prescriptions. Before dispensing any benzodiazepine, the pharmacist should educate the patient on the dose, side effects, and duration of usage. If the pharmacist suspects the liberal prescribing of such drugs by any healthcare worker, then a report should be made to the local DEA office. Only through diligent and safer prescribing habits can the problem of benzodiazepine toxicity be decreased. [10]

When benzodiazepines are ingested alone, they are rarely associated with a poor outcome, but when they are ingested with other agents like alcohol, opiates, or other sedatives, there is a risk of morbidity and even death. All benzodiazepines can cause apnea, but the risk is highest with alprazolam. With the availability of flumazenil, the risk of death is low. These drugs are good sedatives, but they also have a risk of addiction and tolerance. Many people remain addicted to benzodiazepines because of empirical prescribing by healthcare workers. [2] [3]  [Level 5]

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Disclosure: Michael Kang declares no relevant financial relationships with ineligible companies.

Disclosure: Michael Galuska declares no relevant financial relationships with ineligible companies.

Disclosure: Sassan Ghassemzadeh declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

  • Cite this Page Kang M, Galuska MA, Ghassemzadeh S. Benzodiazepine Toxicity. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Overdoses Involving Xylazine Mixed with Fentanyl: Clinical and Public Health Implications

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WTOP News

Concerning substance use trends among Loudoun Co. students go beyond fentanyl

Scott Gelman | [email protected]

February 19, 2024, 6:25 PM

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The majority of Loudoun County Public School students aren’t using drugs, school leaders said at a recent meeting, but those who are tend to misuse alcohol, marijuana and electronic cigarettes, among other substances, and have developed new ways to hide them.

At last week’s school board meeting, Jennifer Evans, the division’s director of student mental health services, said most students are making healthy decisions with regard to substances. However, the students who misuse substances lack refusal skills and make decisions that may be influenced by mental health concerns, family stress or other conflicts, Evans said.

The trends are also driven by students who are impacted by peer pressure, navigating anxiety and depression, have ambitious goals and want the stamina to study all night or are naturally curious, Evans said.

The presentation didn’t include data but laid out trends among students.

“We all went through some of those stages,” Evans said. “But the decisions we had to face at our age back then were not deadly. There weren’t mistakes that we could make that would kill us. And now we have that with fentanyl.”

The school division is hosting a series of community fentanyl awareness events , and Evans said it’s commonly found in pills that are made to resemble drugs such as Xanax, Valium, Klonopin, Percocet, OxyContin and Vicodin.

Some students who have prescriptions will share the drugs with other kids, she said, but “what we’re seeing now is the pills having fentanyl.”

“Kids are buying these illicitly believing they’re actually these drugs, and not knowing there’s fentanyl in them,” Evans said.

But, Evans said, there are other concerning trends that are emerging.

Students, she said, don’t seem to be socially drinking alcohol. Instead, they’re binge drinking and finding drinks that have higher percentages of alcohol in them. They’re also mixing alcohol with caffeine.

E-cigarettes are also popular but have consequences, Evans said. For one, teens who start vaping are more likely to start smoking traditional cigarettes. When students use vaping devices, they’re “breathing in droplets of liquid chemicals and toxic metals into your lungs,” Evans said.

Some students are using marijuana cartridges, or carts, which Evans described as a highly concentrated form of the drug. THC is extracted from the marijuana leaf, making a waxlike substance that is put into devices and smoked. The THC content is usually 80-90%, Evans said, so some students overdo it, which is colloquially called “greening out.”

“It can cause agitation, psychotic symptoms, nausea, hearing voices and distress, which can look like a psychotic break,” Evans said. “So we have seen that and then found out it was because a student admits they smoked marijuana.”

An emerging market for devices to hide drugs poses another challenge for school leaders. Some hats have pockets in them, Evans said, and there’s a new type of sweatshirt on which the hood’s string is actually a vape. There’s also a stash-pocket backpack, she said.

The school district is taking steps to increase awareness about the dangers of drug misuse with campaigns for both students and parents, Evans said.

More information about how the county is working through substance use patterns is available online .

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© 2024 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

Scott Gelman is a digital editor and writer for WTOP. A South Florida native, Scott graduated from the University of Maryland in 2019. During his time in College Park, he worked for The Diamondback, the school’s student newspaper.

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Mother charged with murder in fentanyl death of 3-year-old in D.C.

presentation of xanax

A D.C. woman was charged Friday with first-degree murder in the 2022 death of her 3-year-old daughter, who authorities said ingested her mother’s Percocet that was laced with fentanyl and had been left on the bed where the child was napping.

The girl, Journey McCoy, who lived with her mother in Southeast, died shortly after arriving at United Medical Center the afternoon of Oct. 28, 2022, according to police and prosecutors.

In court documents, authorities described desperate attempts to save Journey after her mother, 27-year-old Sasha McCoy, rushed her out of an apartment building on Stanton Road after finding her unresponsive and turning purple.

A crowd quickly gathered, and several people called 911 as a bystander began CPR. A 911 operator heard someone screaming, “Come on, Sasha,” according to an arrest affidavit filed in court. Police and paramedics were dispatched at 4:47 p.m., as bystanders, McCoy and Journey piled into a vehicle and sped off to the hospital.

A doctor pronounced her dead at 5:09 p.m.

In addition to murder, McCoy was charged with cruelty to children. At a hearing Friday, a D.C. Superior Court magistrate judge ordered McCoy detained and set a court date for March 8. McCoy’s attorney, Elizabeth Weller, declined to comment when reached Saturday.

In the court documents, prosecutors allege that McCoy intentionally and recklessly engaged “in conduct which created a grave risk of bodily injury to Journey McCoy.”

Cause of death: Washington faltered as fentanyl gripped America

A spokeswoman for the U.S. attorney’s office in D.C., which prosecutes adult felonies in the District, could not recall a previous case of a parent charged with murder in a child’s fentanyl overdose. Efforts to reach relatives of McCoy and Journey on Saturday were not successful.

Law enforcement authorities in the District and elsewhere have made targeting fentanyl a priority, noting the synthetic opioid is up to 100 times as powerful as morphine and up to 50 times as potent as heroin. It is often used as a cheap filler hidden in other drugs.

Last year, D.C. Mayor Muriel E. Bowser (D) declared a public emergency over the opioid crisis, directing city agencies to track overdoses more efficiently and to help outreach teams reach those in need, though that declaration was recently allowed to expire . Opioid overdose deaths last year far exceeded violent homicides in the District.

In 2022, a total of 19 people died in two separate mass-casualty fentanyl overdoses in Northeast and Southwest Washington. Police made arrests in one of the incidents. Last year, police arrested more than a dozen people they linked to a cross-country fentanyl ring. They said that investigation began when a young mother in D.C. overdosed and died after taking a single Percocet pill laced with fentanyl.

The D.C. police department’s Special Victims Unit investigated Journey’s death. The initial autopsy, conducted the day after Journey died, revealed abrasions on Journey’s face that appeared to be from scratching, but no significant trauma. The autopsy report listed the cause of her death as “pending.”

According to the arrest affidavit, McCoy told police at the hospital that she had fallen asleep in an apartment where she worked as a home health aide. She told police the man she cared for was bed-bound, but he was hospitalized at the time, the affidavit says. Two acquaintances disputed that McCoy had a job, according to the affidavit.

McCoy told police she had four children and, after taking a nap, she awoke to find two of them “messing” around in the refrigerator. She told police she checked on Journey at least twice during her nap.

The final time she checked, McCoy told police she found Journey in bed with “a lot of yellow mucus coming from her mouth, as if she was choking,” the affidavit says. She then rushed her daughter outside, and to the hospital.

Police said they returned with McCoy to the Stanton Road apartment. In the room where Journey had been napping, police said in the affidavit, they found a queen-size bed with blue sheets and a burgundy blanket that had been pulled off the mattress. An open bag was on top of the bed with two round Percocet pills stamped with an “M” and half of an oval-shaped Xanax pill, according to the affidavit.

A child’s bottle was on the floor, along with a piece of oatmeal cake.

McCoy told police that she had seven Percocet pills, the affidavit says, although she wasn’t sure that was an accurate count. “When you’re used to taking them and having so many,” the affidavit quotes her as telling police, “you just pop’em, pop’em and pop’em.”

The mother then told police, according to the affidavit, that the pills police found on the bed are ones she may have dropped while picking up her unresponsive daughter. “I know how ya’all are gonna make it seems,” she told police, according to the affidavit. “It’s not how it seems. I dropped it right there when I picked my baby up.”

Under pressure to do more, Bowser declares public emergency on opioids

The affidavit says that toxicology tests revealed that two of the pills contained fentanyl. The D.C. medical examiner’s office eventually ruled that Journey had died of fentanyl intoxication.

The affidavit filed in Journey’s death says that investigators with D.C. Child Protective Services visited McCoy, who had four children, at least twice. In September 2020, the affidavit says, McCoy was alleged to have left two of her children alone when she left to smoke marijuana. The agency could not prove substance abuse but cited her for inadequate supervision, and, according to the affidavit, she agreed to not be under the influence of drugs while caring for her children.

In August 2021, the affidavit says, Child Protective Services referred McCoy to substance abuse treatment after a new baby was born going through withdrawal.

Keith L. Alexander contributed to this report.

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Santa Muerte sacrifices, mutilation killings tied to Juárez woman's arrest in El Paso

Human hearts placed on altars to controversial mexican folk saint.

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An FBI and U.S. Border Patrol task force recently arrested a Juárez woman in a raid at an El Paso motel in a border case featuring a dark brew of drug trafficking, mutilation killings and the occult, officials said.

Michelle Angelica Pineda, aka “La Chely," was wanted in Mexico for allegedly leading an ultra-violent gang crew that cut out the hearts from the dismembered bodies of its victims as offerings to La Santa Muerte, FBI and Chihuahua state officials said.

The 22-year-old woman is accused of taking part in five homicides in Mexico and is suspected in several others as part of a bloodthirsty cell of the Artistas Asesinos street gang in Juárez, the FBI said.

"Pineda was known for her extreme brutality such as dismembering bodies, removing hearts, and placing the hearts in front of 'Santa Muerte' altars and statutes," the FBI said in a news statement.

Santa Muerte is a Mexican folk saint, depicted as a cloaked skeletal grim reaper, who has exploded in popularity among the marginalized and within narco culture even while condemned by the Catholic church.

Catholic church leaders have rebuked worship of Santa Muerte (meaning "Saint Death or "Holy Death") as "spiritually dangerous" superstition, paganism and demonic heresy.

Pineda was allegedly part of a gang crew suspected in more than 20 dismemberment killings in Juárez. The tortured and mutilated bodies were often dumped in public spaces, the Chihuahua Attorney General's Office said.

One Juárez newspaper described Pineda's gang as " narcosatánicos ," claiming the removed hearts were offerings to the devil.

More: Bodies found in 'narco grave' in Juárez home after banner about 'El Pitufo'

In the merciless Juárez criminal underworld, it is common for drug cartels and gangs to behead and dismember victims, leaving body parts in gruesome displays for rivals, police and residents. Juárez had more than 1,100 homicides last year.

In December, the Chihuahua Attorney General's Office announced the arrests of four alleged gang members suspected in mutilation killings, including Pineda. A few weeks later, the attorney general's office issued a correction saying Pineda had not been arrested and was still a fugitive.

FBI, Border Patrol arrests 'La Chely' in El Paso

In the early morning of Thursday, Feb. 15, members of the FBI El Paso Safe Streets Gang Task Force and U.S. Border Patrol agents located and arrested Pineda at a motel in East El Paso, an FBI spokesperson said. The name of the motel was withheld.

The FBI said that an investigation had found that Pineda, who is a Mexican citizen, had illegally crossed the border and was allegedly running a drug-dealing ring on behalf of the Artistas Asesinos gang in Juárez.

Inside the motel room, federal agents found machetes, knives, a shotgun, a revolver as well as a variety of drugs —fentanyl powder and pills, heroin, cocaine, Xanax and methamphetamine, the FBI and Border Patrol said.

Border Patrol agents arrested Pineda, who was taken to the middle of one of the international bridges and handed to Chihuahua state investigators. She is now jailed in Mexico.

Pineda has been formally accused of taking part in the killing of a couple on Nov. 24 and the slaying of man on Dec. 5, both cases in the southeastern edges of Juárez, the Chihuahua attorney general's office said over the weekend.

The man, identified only as Jorge R.R., had his neck slashed, his body was then hacked to pieces at a house before the remains were placed inside plastic bags and dumped in El Mezquital area of the city, authorities said.

Mexican drug cartels: 'El 80' pleads guilty in US court, case gives view into Juárez drug cartel

A break in the investigation occurred when municipal police stopped a person found with blood stains near the site where a mutilated corpse had been dumped, Carlos Manuel Salas, the state attorney general for the Northern Zone of Chihuahua, said at a news conference in December.

Investigators followed up by searching four locations, where they found blood evidence and seized cellphones that the killers used to record the executions on video, Salas said. "They are perverse people," he said.

The killers are part of a cell of the Artistas Asesinos gang allegedly following the instructions and orders of an imprisoned gang leader known as "El Niko," the prosecutor said.

The Artistas Asesinos (Artist Assassins) is a violent street gang that got started as a Juárez graffiti crew in the early 2000s. The gang — which operates in the streets and prisons in Juárez — are also known as the " Doble A " (Double A or AA) and " Doblados ," in reference to the double A of their name.

Pineda has had run-ins with the law since she was 13 years old, Salas told El Heraldo de Juárez newspaper, describing her as a "young woman who grew up surrounded by violence" in and outside her home before becoming involved with the Artistas Asesinos and rising in the gang's ranks.

An FBI spokesperson noted that a mug shot photo circulating on some area news outlets is that of the wrong woman.

Santa Muerte belief, prayers and offerings

Believers of the Santa Muerte, affectionally called " La Niña Blanca " and "The White Lady," typically place altar offerings of fruit, such as red apples, food, cigarettes and alcohol, not blood sacrifices, researchers and devotees said.

Belief in the Santa Muerte has "really grown not just in Mexico but here in the United States and in other parts of the world," said Robert Almonte, a law enforcement consultant who gives training seminars to police nationwide on Mexican drug cartels.

Archives: Drug cartels seek help from Catholic saints, Santa Muerte, expert says

Almonte is a former U.S. marshal for the Western District of Texas and a retired deputy chief with the El Paso Police Department. He started researching saints revered by Mexican drug traffickers in the 1980s while working as an El Paso police narcotics officer.

"I think a lot of it (the spread of the Santa Muerte cult) is word of mouth and what people have had all their life hasn’t been enough. They believe in the Catholic saints and Jesus Christ and they believe that’s not enough. They hear that someone’s prayers were answered by Santa Muerte and they decide why not give it a shot," Almonte said.

There is no one standard set of beliefs and practices and rituals can vary among followers of " La Flaquita ," the Skinny Lady.

Word of mouth and books are not as necessary as in the past with extensive information on Santa Muerte worship easily available to anyone on internet videos, blogs and social media. Music videos on YouTube sing her praises.

“When I do my training with law enforcement officers, I emphasize that there are a lot of people who are not involved in criminal activity who pray to Santa Muerte," Almonte said in a phone interview on Monday while traveling to give a seminar in the Minneapolis area.

Believers view Santa Muerte as "neutral" spiritual entity, a nonjudgmental protector, accepting of anyone regardless of nationality, skin color, gender, sexual orientation and socio-economic status.

Devotees pray to her for things such as health, help finding a job and protection, but can also pray for vengeance, recovering a wayward love, wealth and for luck beating a criminal court case.

" Mi querida Santa Muerte siempre guia mi camino, dame fortaleza para vencer el enemigo ," the Mexican rap duo La Familia Hemafia pray in their music video for "Mi Santa Mu3rte" asking the skeletal spirit to guide their path and give them strength to defeat their enemy. The video has over 1.1 million views.

Santa Muerte human sacrifice in the U.S.?

Santa Muerte has references in Mexican culture since Spanish colonial times as the colonizers' Catholicism mixed with belief in the death deities of the native Aztec and Mayan cultures, according to a Catholic News Agency report in 2017.

There was a minor resurfacing of belief in the 1940s in historical records before popularity started growing by the turn of the millennium as devotion became intertwined with Mexico's drug-trafficking culture, the report stated.

More: FBI arrests 'El Alaska' after kidnapped migrant found at El Paso area stash house

"I’ve heard of the offering of hearts to Santa Muerte occurring more often in Mexico. As far as the United States, I have not heard of any heart offerings. I am aware of only one human offering in the United States," Almonte said.

The supposed Santa Muerte human sacrifice case referenced by Almonte was the killing of 6-year-old Nathan Alexander Sanchez, who was stabbed to death by his father in the Los Angeles area in 2014.

Deputies found the boy's father in the front yard covered in blood and "speaking incoherently," the Los Angeles Times reported. The father, who was allegedly under the influence of drugs, pleaded no contest to a murder charge.

Almonte said that a prosecutor and detective contacted him, telling him that the father was frequenting a local Santa Muerte temple and praying for hours before stabbing his son to death allegedly as an offering to Santa Muerte. Almonte wrote about the case in a column last fall in the magazine of the National Narcotics Officers' Coalition.

There is no mention of Santa Muerte in news accounts of the boy's death and no motive was given in the killing.

The Santa Muerte does not require human or animal blood offerings. “She’s not Dracula," said the narrator in a video on the YouTube channel "Todo sobre La Santa Muerte" (Everything about the Santa Muerte). The Spanish-language channel has more than 260 videos answering a wide range of questions about the cult.

There are some Santa Muerte believers who make blood pacts in seeking favors and there are some involved in devil worship and black magic rituals, but those are "microscopic" in number compared to all followers, the narrator said.

The Santa Muerte is a protector who requires faith, respect and gratitude, the unnamed video narrator said. "The Santa Muerte is not evil. Evil only exists in people."

'They are not afraid to die'

The heart offerings case in Juárez is a twist of dark spirituality entwined with the blood-soaked drug cartel-related violence and crime that have been a major problem in Mexico for decades.

"I’m seeing these drug traffickers who pray to Santa Muerte are becoming more bold," Almonte commented.

More: Who is Jesus Malverde? Other narco-saints of Mexico

"The drug traffickers truly believe that no matter what they do in life, including cutting hearts out, beheading people, that they will go to heaven," Almonte said.

"They are not afraid to die. They truly believe that because they worship Santa Muerte she will take them to heaven."

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