What is Bromazepam used for?

Bromazepam is evaluated for the following indications with varying evidence strength: Generalized anxiety disorder (evidence tier B), Insomnia (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Bromazepam?

Common side effects of Bromazepam (≥ 1 in 100): Drowsiness, daytime sedation, Ataxia, impaired coordination, Muscle weakness, Dizziness, Anterograde amnesia, Cognitive impairment. See the Safety section for uncommon and serious reactions.

Is Bromazepam safe during pregnancy?

FDA category D. Category D. Contraindicated: linked to birth defects (cleft palate) in trimester 1; «floppy infant» syndrome (hypotonia, neonatal respiratory depression) in trimester 3.

Is Bromazepam compatible with breastfeeding?

Contraindicated: drug is excreted in breast milk, causing infant sedation and weight loss.

Who should not take Bromazepam?

Bromazepam is contraindicated in: Myasthenia gravis; Acute alcohol, opioid, or barbiturate intoxication; Severe respiratory failure; Sleep apnea syndrome; Severe hepatic impairment. Full list in the Safety section.

Bromazepam

AEMPS

Anxiolytics, benzodiazepine derivatives

ATC code: N05BA08 (Bromazepam)

Brand names

Lexotan, Lectopam, Lexilium, Lexatin

Mechanism of action

Bromazepam is a medium-acting benzodiazepine. It potentiates GABA action at GABA-A receptors, increasing chloride channel opening frequency. Effects include anxiolytic, sedative, muscle-relaxant, and anticonvulsant activity. Half-life 10-20 hours; active metabolites are not significantly formed. Widely used in Spain, Portugal, Italy, and Germany for anxiety disorders. Registered in Russia but used less than phenazepam and tofisopam.

Indications

Generalized anxiety disorder

Second line

Bromazepam is second-line therapy for generalized anxiety disorder (GAD), used for short-term (up to 2-4 weeks) control of severe anxiety and panic symptoms. The Reinhold 2015 meta-analysis (benzodiazepines in GAD) shows efficacy comparable to other short and intermediate-acting benzodiazepines. CG113, WFSBP, and GAD guidelines list SSRIs/SNRIs and CBT as first-line; benzodiazepines are reserved for short-term use in severe anxiety until antidepressant effect develops. Dose 1.5-9 mg/day in 2-3 doses. Continuous treatment should not exceed 8-12 weeks due to dependence risk.

Bromazepam

Mechanism of action

Indications

Generalized anxiety disorder

Marketing claims without evidence base

Insomnia

Practical notes

Russian practice note

Drug interactions

Check interaction with another drug

Official sources

Safety

Contraindications

Serious adverse effects

Common adverse effects

PregnancyFDA D

Breastfeeding

Frequently asked