Xanax XR - Drug Monograph

Comprehensive information about Xanax XR including mechanism, indications, dosing, and safety information.

Introduction

Xanax XR (extended-release alprazolam) is a benzodiazepine medication primarily used for the management of panic disorder with or without agoraphobia. It is the extended-release formulation of alprazolam, designed to provide sustained therapeutic effects with less frequent dosing compared to the immediate-release formulation.

Mechanism of Action

Alprazolam potentiates the effects of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. It binds to specific sites on the GABA-A receptor complex, enhancing GABA-mediated chloride ion channel opening. This results in increased neuronal membrane hyperpolarization and reduced neuronal excitability, producing anxiolytic, sedative, muscle relaxant, and anticonvulsant effects.

Indications

Xanax XR is FDA-approved for:

  • Treatment of panic disorder with or without agoraphobia
  • Maintenance therapy after initial stabilization with immediate-release alprazolam

Dosage and Administration

Initial dosage: 0.5-1 mg orally once daily, preferably in the morning Dosage adjustment: May be increased every 3-4 days by no more than 1 mg daily Maximum dosage: 10 mg daily (though typically not exceeding 4 mg daily for most patients) Special populations:
  • Geriatric patients: Initial dose 0.5 mg once daily
  • Hepatic impairment: Reduce dose by 50% or more
  • Renal impairment: Use with caution; no specific dosage adjustment recommended

Pharmacokinetics

Absorption: Bioavailability approximately 90%; peak concentration reached 5-11 hours after dosing Distribution: Volume of distribution 0.8-1.3 L/kg; 80% protein-bound Metabolism: Extensive hepatic metabolism via cytochrome P450 3A4 (CYP3A4) to active metabolites including α-hydroxyalprazolam Elimination: Half-life 10.7-15.8 hours; primarily renal excretion (80% as metabolites)

Contraindications

  • Hypersensitivity to alprazolam, other benzodiazepines, or any component of the formulation
  • Acute narrow-angle glaucoma
  • Concomitant use with strong CYP3A inhibitors (ketoconazole, itraconazole)
  • Myasthenia gravis
  • Severe respiratory insufficiency
  • Sleep apnea syndrome
  • Severe hepatic impairment

Warnings and Precautions

Boxed Warning:
  • Risk of abuse, misuse, and addiction which can lead to overdose or death
  • Physical dependence and withdrawal reactions
  • Risks from concomitant use with opioids
Additional warnings:
  • Sedation and impaired coordination: Caution when operating machinery or driving
  • Depression and suicidal ideation: Monitor for emergence or worsening of depression
  • Paradoxical reactions: Including excitement, stimulation, and acute rage
  • Elderly patients: Increased risk of falls and cognitive impairment
  • Pregnancy: Potential neonatal withdrawal syndrome and teratogenic effects
  • Withdrawal symptoms: Can be life-threatening; taper gradually

Drug Interactions

Major interactions:
  • CYP3A4 inhibitors (azole antifungals, macrolide antibiotics, protease inhibitors): Increased alprazolam levels
  • CYP3A4 inducers (carbamazepine, phenytoin, rifampin): Decreased alprazolam levels
  • Opioids: Increased risk of respiratory depression, sedation, and death
  • Alcohol: Enhanced CNS depression
  • Other CNS depressants: Additive effects
Moderate interactions:
  • Oral contraceptives: May decrease alprazolam clearance
  • Digoxin: Increased digoxin levels possible
  • Imipramine/desipramine: Increased plasma concentrations

Adverse Effects

Common (≥10%):
  • Somnolence (41%)
  • Fatigue (14%)
  • Impaired coordination (8-12%)
  • Memory impairment (6-12%)
  • Depression (6-12%)
Less common (1-10%):
  • Dizziness, lightheadedness
  • Headache
  • Cognitive disorder
  • Constipation
  • Dry mouth
  • Weight changes
Serious (<1%):
  • Respiratory depression
  • Dependence and withdrawal
  • Suicidal ideation
  • Jaundice
  • Seizures (upon withdrawal)
  • Hypomania/mania

Monitoring Parameters

  • Efficacy: Panic attack frequency and severity, anxiety symptoms
  • Safety: Sedation level, coordination, cognitive function
  • Psychiatric: Depression, suicidal thoughts, paradoxical reactions
  • Addiction potential: Signs of misuse, abuse, or dependence
  • Withdrawal symptoms: Especially during dose reduction
  • Hepatic function: Periodically in long-term therapy
  • Renal function: In patients with renal impairment

Patient Education

  • Take exactly as prescribed; do not increase dose without medical supervision
  • Swallow tablets whole; do not crush, chew, or break
  • Avoid alcohol and other CNS depressants
  • Do not abruptly discontinue; taper under medical supervision
  • Be aware of potential impairment of mental and physical abilities
  • Report any thoughts of self-harm or worsening depression
  • Use effective contraception if of reproductive potential
  • Store securely to prevent misuse by others
  • Keep all medical appointments for monitoring

References

1. Xanax XR [package insert]. New York, NY: Pfizer; 2021. 2. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). 3. Baldwin DS, et al. Benzodiazepines: risks and benefits. Int J Psychiatry Clin Pract. 2013;17(2):85-90. 4. Guina J, et al. Benzodiazepines for PTSD: A systematic review and meta-analysis. J Psychiatr Pract. 2015;21(4):281-303. 5. Lader M. Benzodiazepines revisited—will we ever learn? Addiction. 2011;106(12):2086-2109. 6. FDA Drug Safety Communication: FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class. September 2020. 7. Schatzberg AF, et al. Manual of Clinical Psychopharmacology. 9th ed. American Psychiatric Publishing; 2019.

Medical Disclaimer

The information provided in this article is for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

The content on MedQuizzify is designed to support, not replace, the relationship that exists between a patient and their healthcare provider. If you have a medical emergency, please call your doctor or emergency services immediately.

How to Cite This Article

admin. Xanax XR - Drug Monograph. MedQuizzify [Internet]. 2025 Sep 10 [cited 2025 Sep 10]. Available from: http://medquizzify.pharmacologymentor.com/blog/drug-monograph-xanax-xr

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