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Bromazepam

AEMPS

Anxiolytics, benzodiazepine derivatives

ATC code: N05BA08

Brand names: Lexotan, Lectopam, Lexilium, Lexatin

Updated · Methodology

Indications

B

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.

Sources

  1. AEMPS: Ficha técnica de Bromazepam (2024)

ICD-10: F41.1 · ICD-11: 6B00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

C

Insomnia and sleep disorders

Not recommended

For insomnia, bromazepam is used off-label at 1.5–3 mg at bedtime. and ESRS guidelines list CBT-I as first-line for chronic insomnia; pharmacotherapy is second-line. Among hypnotics, z-drugs (zopiclone, zolpidem) and sedating antidepressants (trazodone, mirtazapine) are preferred. Benzodiazepines with long half-life (bromazepam, diazepam) are not recommended for insomnia due to daytime residual sedation and cognitive risk in older adults.

Sources

  1. AEMPS: Ficha técnica de Bromazepam (2024)
  2. Cochrane: Melatonin for sleep disorders (2018)

ICD-10: G47.0 · ICD-11: 7A00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

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.

Safety

Contraindications

  • Myasthenia gravis
  • Acute alcohol, opioid, or barbiturate intoxication
  • Severe respiratory failure
  • Sleep apnea syndrome
  • Severe hepatic impairment
  • Narrow-angle glaucoma
  • Pregnancy and breastfeeding
  • Age under 18

Serious adverse effects

  • Respiratory depression (especially with opioids)
  • Psychological and physical dependence
  • Withdrawal syndrome: anxiety, insomnia, tremor, in severe cases seizures
  • Paradoxical reactions (agitation, aggression) – more common in older adults and children

Common adverse effects

  • Drowsiness, daytime sedation
  • Ataxia, impaired coordination
  • Muscle weakness
  • Dizziness
  • Anterograde amnesia
  • Cognitive impairment

Pregnancy: can you take Bromazepam?

AEMPS summary of product characteristics (section 4.6): the toxicological safety of bromazepam in pregnant women has not been established, although a review of spontaneous reports found that the incidence of side effects was no higher than expected in a similar untreated population. Several studies have linked first-trimester use of minor tranquillisers (diazepam, meprobamate and chlordiazepoxide) to an increased risk of congenital malformations. Bromazepam should be avoided in pregnancy unless there is no toxicologically safer alternative, and treatment is withdrawn when a pregnancy is planned or detected. If it is given late in pregnancy or at high doses during labour for strict medical reasons, the newborn may develop hypothermia, hypotonia and moderate respiratory depression. Infants of mothers who took benzodiazepines chronically in late pregnancy may develop physical dependence and a postnatal withdrawal syndrome.

Breastfeeding: can you take Bromazepam?

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

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

In Russia, bromazepam is listed as a controlled psychotropic substance (Schedule III). Strict prescription on form 148–1/u-88. Monthly cost (60 tablets of 1.5 mg) is 800–1500 ₽. In Spain and Portugal, bromazepam (Lexatin, Lexotan) is one of the most prescribed benzodiazepines. Course duration should not exceed 4–12 weeks due to tolerance and dependence. Gradual taper: 25% dose reduction every 1–2 weeks to prevent withdrawal. In older adults, dose is halved due to increased fall and cognitive impairment risk.

Drug interactions

Additive CNS depression with other depressants – alcohol (prohibited), opioids, barbiturates, antipsychotics, first-generation antihistamines. Severe respiratory depression risk with opioid combination – black box warning issued in 2016. Metabolized by CYP3A4 – inhibitors (ketoconazole, itraconazole, clarithromycin, grapefruit) raise bromazepam concentration. Benzodiazepines reduce levodopa efficacy.

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Frequently asked

What is Bromazepam used for?

Bromazepam is evaluated for the following indications with varying evidence strength: Generalized anxiety disorder (evidence tier B), Insomnia and sleep disorders (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?

AEMPS summary of product characteristics (section 4.6): the toxicological safety of bromazepam in pregnant women has not been established, although a review of spontaneous reports found that the incidence of side effects was no higher than expected in a similar untreated population. Several studies have linked first-trimester use of minor tranquillisers (diazepam, meprobamate and chlordiazepoxide) to an increased risk of congenital malformations. Bromazepam should be avoided in pregnancy unless there is no toxicologically safer alternative, and treatment is withdrawn when a pregnancy is planned or detected. If it is given late in pregnancy or at high doses during labour for strict medical reasons, the newborn may develop hypothermia, hypotonia and moderate respiratory depression. Infants of mothers who took benzodiazepines chronically in late pregnancy may develop physical dependence and a postnatal withdrawal syndrome.

Is Bromazepam compatible with breastfeeding?

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

Can you drink alcohol while taking Bromazepam?

Additive CNS depression with other depressants – alcohol (prohibited), opioids, barbiturates, antipsychotics, first-generation antihistamines.

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.

Official sources

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