Section 01 · Monograph

Clorazepate

Reviewed Nov 2026FDA label
Tranxene T-TabBenzodiazepine
Forms
Tab: 3.75, 7.5, 15mg
Dose
Adjunct partial seizures: start 7.5mg TID, increase 7.5mg weekly, max 90mg/day
MOA
↑GABA-A Cl- channel frequency

Black Box Warning

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma and death
  • Abuse, misuse and addiction risk
  • Dependence and withdrawal reactions

Indications

  • Adjunctive therapy for partial seizuresFDA-labeled
  • Anxiety disordersFDA-labeled
  • Acute alcohol withdrawalFDA-labeled

Mechanism of Action

  • Prodrug converted to the active metabolite desmethyldiazepam; benzodiazepine positive modulation of GABA-A receptors

Full Dosing

Adult / usual

  • Adjunct for partial seizures, adults and age over 12: start 7.5mg TID, increase by no more than 7.5mg weekly; maximum 90mg/day
  • Ages 9-12: start 7.5mg BID; maximum 60mg/day
  • Taper gradually to avoid withdrawal seizures

Contraindications

  • Acute narrow-angle glaucoma
  • Known hypersensitivity

Drug Interactions

  • Opioids and other CNS depressants: profound sedation
  • CYP inhibitors may raise levels

Adverse Effects

  • Sedation, dizziness, ataxia
  • Dependence and withdrawal
  • Respiratory depression with opioids

Monitoring Parameters

  • Sedation and cognitive effects
  • Misuse risk
  • Seizure control and gradual taper

Pregnancy & Lactation

  • Late-pregnancy exposure can cause neonatal sedation or withdrawal
  • Present in milk; monitor infants

References

  1. TRANXENE T-TAB (clorazepate) Prescribing Information — DailyMed (NIH) search

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