Bromazepam is indicated for:

• Emotional disturbances such as acute tension, anxiety, difficulty in interpersonal relationships, agitation, insomnia, and anxious or agitated depressive states.
• Functional disorders of the cardiovascular and respiratory systems, including pseudoangina pectoris, cardiac anxiety, tachycardia, stress-related hypertension, dyspnea, and hyperventilation.
• Gastrointestinal disorders such as irritable bowel syndrome, epigastric pain, spasms, bloating, and diarrhea.
• Urinary tract disturbances including increased frequency, irritable bladder, and dysmenorrhea.
• Psychosomatic conditions such as psychogenic headache, asthma, gastric and duodenal ulcers.
• Emotional reactions associated with chronic organic diseases.

Bromazepam is a potent psychotropic agent. At lower doses, it primarily reduces anxiety and tension. At higher doses, it exhibits sedative and muscle-relaxant effects. It acts by binding to the GABA-A receptor, enhancing inhibitory neurotransmission through conformational changes. Other neurotransmitter systems remain largely unaffected.

Standard dosage: Average dosage for outpatient therapy is 1.5–3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6–12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8–12 weeks. In certain cases extension beyond the maximum treatment period may be necessary: if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1–0.3 mg/kg bodyweight)

Administration

Bromazepam tablets are for oral administration

When bromazepam is used together with other centrally acting drugs, its sedative effect may be enhanced. These include antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptics, sedating antihistamines, and anesthetics. Co-administration with cimetidine may prolong the elimination half-life of bromazepam. Alcohol should be avoided during treatment, as it can further increase the sedative effects of bromazepam.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic impairment, or sleep apnea syndrome.

Common side effects include fatigue, drowsiness, muscle weakness, muscle numbness, reduced alertness, confusion, headache, and ataxia.
These effects are more common at the beginning of treatment and usually decrease with continued use. Anterograde amnesia may occur even at therapeutic doses.

The safety of bromazepam during pregnancy has not been established. Since bromazepam is excreted in breast milk, its use should be avoided during breastfeeding.

Benzodiazepines and similar agents may lead to physical and psychological dependence. The risk increases with higher doses and prolonged use, especially in patients with a history of alcohol use. Abrupt discontinuation after dependence has developed may result in withdrawal symptoms such as headache, muscle pain, severe anxiety, tension, confusion, and irritability. Therefore, gradual dose reduction is recommended. Bromazepam is not suitable for the primary treatment of insomnia related to psychotic disorders. Patients should exercise caution when driving or operating machinery.

Benzodiazepine sedatives

Store in a dry place, away from heat and light. Keep out of reach of children.