Alprazolam

ATC code

N05BA12

Therapeutic class

Anxiolytic · Benzodiazepine derivative

Forms

oral tablet

Brand names

Xanax (US) · Tafil (MX) · Alprazolam Cinfa (ES) · Xanax (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-2ad46bf8-1d4d-2bc8-e063-6294a90a9ef0
aemps-cima-ft-64214
ansm-bdpm-rcp-69847791
PubMed PMID:38014714 ↗
PubMed PMID:34475580 ↗
OpenFDA · N05BA12
RxNorm rxcui 596 ↗

Approved indications

Acute treatment of generalized anxiety disorder (GAD) in adults.
Treatment of panic disorder (PD), with or without agoraphobia in adults.

Contraindications

Absolute

Known hypersensitivity to alprazolam or other benzodiazepines.
Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole).
Severe respiratory insufficiency.
Sleep apnea syndrome.
Severe hepatic impairment.
Myasthenia gravis.

Clinical warnings

Boxed warning · Risks from concomitant use with opioids (profound sedation, respiratory depression, coma, death); abuse, misuse, and addiction; dependence and life-threatening withdrawal reactions. — FDA

Drug interactions

HighOpioidsN02A
Mechanism: Additive CNS depressant effects at different receptors (GABA-A and mu-opioid), increasing the risk of respiratory depression, profound sedation, and coma.
Recommendation: Limit dosage and duration to the minimum required. Closely monitor for sedation and respiratory depression. Reserve for patients with no alternative treatment options.
FDA label
HighStrong CYP3A4 inhibitors (e.g., Ketoconazole)J02AB02
Mechanism: Inhibition of alprazolam metabolism via CYP3A4, resulting in a significant increase in its plasma concentrations and risk of toxicity.
Recommendation: Concomitant use is contraindicated.
FDA label
ModerateDigoxinC01AA05
Mechanism: Increased digoxin concentrations, especially in elderly patients. The exact mechanism is not fully elucidated.
Recommendation: Monitor serum digoxin concentrations and watch for signs of digitalis toxicity when starting or stopping alprazolam.
FDA label

Adverse events

Common (≥1%)

sedation · drowsiness · ataxia · memory impairment · dysarthria · dizziness · headache · fatigue · irritability · decreased libido · constipation

Rare but serious

respiratory depression · dependence · withdrawal syndrome · abuse · paradoxical reactions (agitation, anger) · hepatitis · angioedema · anterograde amnesia

Pregnancy and lactation

FDA category: D

Use during pregnancy, especially in the third trimester, may cause neonatal sedation and withdrawal syndrome. Breastfeeding is not recommended due to the risk of sedation and other adverse effects in the infant.

Recent literature (PubMed)

Pharmacological treatments in panic disorder in adults: a network meta-analysis.
Guaiana G, et al. · Cochrane Database Syst Rev · 2023 · Relevance 5/5
Revisión sistemática y metaanálisis en red de Cochrane que compara la eficacia y aceptabilidad de diversos fármacos (antidepresivos y benzodiazepinas) frente a placebo para el tratamiento agudo del trastorno de pánico en adultos. El objetivo es clasificar los fármacos individuales y las clases de fármacos según su efectividad y aceptabilidad.
A review of pre-appointment medications to reduce fear and anxiety in dogs and cats at veterinary visits.
Erickson A, et al. · Can Vet J · 2021 · Relevance 1/5
Revisión de la literatura sobre medicamentos pre-cita (gabapentina, trazodona, dexmedetomidina y alprazolam) para disminuir el miedo y la ansiedad situacional aguda en perros y gatos durante las visitas veterinarias. Revisa el uso, mecanismo de acción y farmacocinética en estas especies.