In short
Bromazepam is a benzodiazepine medicine used in some countries for the short-term treatment of severe anxiety and panic symptoms in adults. In the clinical trials data provided, it appears as a comparator in one authorised low-intervention trial involving 240 patients undergoing vitrectomy and/or cataract surgery, where it is given orally before retrobulbar anaesthesia.
Key points
- Bromazepam is a benzodiazepine used for short-term severe anxiety and panic symptoms in adults.
- In the trial data, bromazepam is a comparator, not the main studied substance.
- The trial is authorised and classified as low intervention.
- The trial enrolled 240 participants undergoing vitrectomy and/or cataract surgery.
- The primary outcome is the NRS-P score 30 seconds after retrobulbar block.
- Bromazepam is given orally as a film-coated tablet in the trial.
What is bromazepam?
Bromazepam is a medicine that belongs to a group called benzodiazepines, which act on the brain to reduce anxiety and promote calm and sleepiness. It is used in some countries for the short-term treatment of severe anxiety and panic symptoms in adults. It is not available in the United States, where other benzodiazepines approved by the FDA, such as diazepam, lorazepam, or alprazolam, are used instead for anxiety or panic disorders.
Bromazepam is a chemically synthesised substance. In the European Union clinical trial records, it appears as a film-coated tablet for oral use, already authorised as a medicine in Austria. The authorisation holder is Genericon Pharma Gesellschaft m.b.H., and the product name given is bromazepam Genericon 3 mg Filmtabletten. Other foreign brand names include Lexotan, Lexomil, and many others listed in international sources.
How does bromazepam work?
Bromazepam works by acting on the brain to reduce anxiety and promote calm and sleepiness. In animal studies, bromazepam has shown anti-anxiety, sedative, muscle-relaxant, and anticonvulsant properties. It is generally prescribed for a short time to relieve severe anxiety or panic symptoms in adults, often while longer-term treatments such as antidepressants or psychological therapies begin to work.
Which conditions is bromazepam used or studied for?
- Severe anxiety and panic symptoms – bromazepam is used for the short-term treatment of severe anxiety and panic symptoms in adults.
- Perioperative anxiety and pain – in the clinical trial data, bromazepam is used as a comparator in a trial investigating perioperative anxiety and pain in patients undergoing vitrectomy and/or cataract surgery.
How is bromazepam given?
Bromazepam is given orally. In the clinical trial records, the pharmaceutical form is a film-coated tablet and the route of administration is oral. The product name in the trial is bromazepam Genericon 3 mg Filmtabletten, and the dose reported in the trial data is 1.5 mg.
What do the clinical trials show?
The clinical trial data contains one trial in which bromazepam appears. The trial is authorised and classified as low intervention. It enrolled 240 participants undergoing vitrectomy and/or cataract surgery.
The trial investigates the effect of music on perioperative pain, and the effect of herbal medicine on perioperative pain. Bromazepam is a comparator in this trial, meaning it is used as a comparison arm rather than being the main substance under investigation. The primary outcome is the NRS-P score, which measures pain, 30 seconds after retrobulbar block.
What side effects are known?
Bromazepam has important safety concerns, including dependence, withdrawal, and overdose risks.