Diazepam

ATC code

N05BA01

Therapeutic class

Anxiolytic, benzodiazepine derivative · Benzodiazepine

Forms

oral tablet

Brand names

Diazepam (US) · Valium (US) · DIAZEPAM CINFA (ES) · DIAZEPAM ACCORD (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-842dfa9a-8c93-4c77-8f6b-95dd175df191
aemps-ft-80699
ansm-rcp-69998003
PubMed PMID:36853245 ↗
PubMed PMID:39025858 ↗
PubMed PMID:36533637 ↗
PubMed PMID:39174250 ↗
PubMed PMID:40280782 ↗
OpenFDA · N05BA01
RxNorm rxcui 3322 ↗

Approved indications

Management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Symptomatic relief in acute alcohol withdrawal (acute agitation, tremor, impending or acute delirium tremens and hallucinosis).
Adjunct for the relief of skeletal muscle spasm, including Stiff-Person Syndrome.
Adjunctive therapy in convulsive disorders.
Treatment of catatonia. · off-label
Treatment of vulvodynia (intravaginal formulation). · off-label

Contraindications

Absolute

Known hypersensitivity to diazepam or other benzodiazepines.
Myasthenia gravis.
Severe respiratory insufficiency.
Severe hepatic insufficiency.
Sleep apnea syndrome.
Acute narrow-angle glaucoma.
Pediatric patients under 6 months of age.

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. Use of benzodiazepines exposes users to risks of abuse, misuse, and addiction. Continued use may lead to physical dependence and life-threatening withdrawal reactions upon abrupt discontinuation. — FDA

Drug interactions

HighOpioids (e.g., morphine, oxycodone)N02A
Mechanism: Additive CNS depression via different receptors (GABA-A for benzodiazepines, μ-opioid for opioids), increasing the risk of severe respiratory depression.
Recommendation: Reserve concomitant use for patients with no alternatives. Use the lowest effective doses for the shortest possible duration. Closely monitor for sedation and respiratory depression.
FDA label Boxed Warning
ModerateCYP3A4/2C19 inhibitors (e.g., cimetidine, ketoconazole, fluvoxamine)A02BA01
Mechanism: Inhibition of CYP3A4 and CYP2C19-mediated metabolism of diazepam, leading to increased plasma concentrations and prolonged sedation.
Recommendation: Monitor for increased sedation. Consider a dose reduction of diazepam.
FDA labelANSM RCP
HighAlcoholV03AB16
Mechanism: Additive CNS depressant effect, enhancing the sedative effect of diazepam.
Recommendation: Concomitant use is not recommended.
FDA labelANSM RCP

Adverse events

Common (≥1%)

drowsiness · fatigue · muscle weakness · ataxia · headache · confusion · vertigo

Rare but serious

respiratory depression · paradoxical reactions (agitation, aggression) · anterograde amnesia · hypotension · hepatotoxicity · neutropenia · falls and fractures

Pregnancy and lactation

FDA category: D (historical)

Use of diazepam late in pregnancy can result in neonatal sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal syndrome. Exposed neonates should be monitored.

Recent literature (PubMed)

Stiff person syndrome.
Cullinane PW, et al. · Handb Clin Neurol · 2024 · Relevance 5/5
Revisión sobre el síndrome de la persona rígida (SPS) que confirma que el diazepam y el baclofeno son los tratamientos de primera línea para este raro trastorno autoinmune, actuando sobre la hiperexcitabilidad central.
Catatonia.
Hirjak D, et al. · Nat Rev Dis Primers · 2024 · Relevance 5/5
Revisión exhaustiva sobre la catatonia, destacando que las benzodiazepinas como el lorazepam y el diazepam son la piedra angular del tratamiento, junto con la TEC y los antagonistas de NMDA.
Evaluation and Treatment of Vulvodynia: State of the Science.
Schlaeger JM, et al. · J Midwifery Womens Health · 2023 · Relevance 4/5
Revisión sobre el tratamiento de la vulvodinia que identifica los comprimidos de diazepam intravaginales como un tratamiento con un alto nivel de evidencia (ensayo controlado aleatorizado), a menudo en combinación con otras terapias.
Borderline Personality Disorder: A Review.
Leichsenring F, et al. · JAMA · 2023 · Relevance 3/5
Revisión sobre el Trastorno Límite de la Personalidad (TLP) que señala que no hay evidencia de que los fármacos psicoactivos mejoren los síntomas centrales. Para crisis agudas, se prefieren antipsicóticos de baja potencia o antihistamínicos sedantes sobre las benzodiazepinas como el diazepam.
Drug-Induced Liver Injury.
Reinhart JM · Vet Clin North Am Small Anim Pract · 2025 · Relevance 3/5
Artículo de revisión en medicina veterinaria que discute la lesión hepática inducida por fármacos (DILI) y menciona al diazepam como uno de los medicamentos con potencial tóxico para el hígado en animales pequeños, lo que corrobora el riesgo de hepatotoxicidad.