Oxazepam

ATC code

N05BA04

Therapeutic class

Benzodiazepine · Anxiolytic

Forms

oral capsule, oral tablet

Brand names

Oxazepam (US) · Seresta (FR) · Serepax (AU)

Overall confidence

high

Regulatory sources consulted

openfda-label-26e63053-7a43-e278-e063-6394a90a23b8
ansm-rcp-69891695
PubMed PMID:35194860 ↗
PubMed PMID:37742220 ↗
PubMed PMID:35048994 ↗
OpenFDA · N05BA04
RxNorm rxcui 7781 ↗

Approved indications

Management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Anxiety associated with depression.
Management of anxiety, tension, agitation and irritability in older patients.
Management of acute tremulousness, or with anxiety associated with alcohol withdrawal.

Contraindications

Absolute

Hypersensitivity to oxazepam or other benzodiazepines.
Severe respiratory insufficiency.
Sleep apnea syndrome.
Severe hepatic insufficiency.
Myasthenia gravis.

Clinical warnings

Boxed warning · RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS: Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death. The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction. Continued use may lead to clinically significant physical dependence and life-threatening withdrawal reactions upon abrupt discontinuation. — FDA

Drug interactions

HighOpioidsN02A
Mechanism: Pharmacodynamic synergy resulting in enhanced CNS depression, with risk of profound sedation, respiratory depression, coma, and death.
Recommendation: Reserve concomitant use for patients with no alternative therapeutic options. Prescribe the lowest effective doses for the minimum duration. Closely monitor for signs of respiratory depression and sedation.
FDA labelANSM SPC
HighAlcoholV03AB
Mechanism: Increased sedative effect and psychomotor impairment due to additive CNS depressant effects.
Recommendation: Avoid intake of alcoholic beverages and medicines containing alcohol during treatment.
ANSM SPC

Adverse events

Common (≥1%)

drowsiness · dizziness · vertigo · headache · ataxia · confusion

Rare but serious

syncope · leukopenia · hepatic dysfunction · jaundice · hypotension · anterograde amnesia · paradoxical reactions

Pregnancy and lactation

FDA category: D

Use of oxazepam is not recommended during pregnancy. Exposure in the 2nd/3rd trimester can cause axial hypotonia and sucking difficulties in the newborn (floppy infant syndrome). High-dose exposure late in pregnancy can cause respiratory depression or apnea and hypothermia in the newborn. Neonatal withdrawal syndrome is possible.

Recent literature (PubMed)

Comparative efficacy and safety of pharmacotherapies for alcohol withdrawal: a systematic review and network meta-analysis.
Bahji A, et al. · Addiction · 2022 · Relevance 4/5
Meta-análisis en red de 149 ECA que evaluó farmacoterapias para el síndrome de abstinencia alcohólica. Oxazepam a pauta fija demostró ser superior al placebo en la mejora de las puntuaciones de la escala CIWA-Ar, aunque no redujo significativamente la incidencia de convulsiones o delirium tremens en comparación con placebo en este análisis.
[Assessment of alcohol withdrawal syndrome: new perspectives].
Kádár BK, et al. · Orv Hetil · 2023 · Relevance 4/5
Revisión sistemática sobre el diagnóstico y tratamiento del síndrome de abstinencia alcohólica. Confirma que las benzodiazepinas, incluyendo oxazepam, son la piedra angular del tratamiento, con evidencia suficiente para su uso en indicaciones específicas dentro de este síndrome.
A review on the forensic toxicology of global drug-facilitated sexual assaults.
Skov K, et al. · Eur Rev Med Pharmacol Sci · 2022 · Relevance 2/5
Revisión de la toxicología forense en casos de agresión sexual facilitada por drogas (DFSA). Identifica a las benzodiazepinas, incluyendo oxazepam, como sustancias frecuentemente detectadas en las víctimas, a menudo en combinación con etanol.