Efficacy and tolerance: comparative studies with brotizolam and flunitrazepam.

Efficacy of and tolerance to 0.25 mg brotizolam and 2.0 mg flunitrazepam were compared over a period of 6 days in ambulatory patients complaining of sleep disturbance. The study was double-blind and randomised with a parallel group design. Both drugs improved sleep. More patients assessed sleep latency as shorter during the first night of ingestion with flunitrazepam than with brotizolam, but assessments were comparable over the next 5 days. The number of patients who considered that the frequency of nocturnal awakenings was less did not differ significantly between drugs. Tolerance to brotizolam (0.25 mg) was assessed more favourably than with flunitrazepam (2.0 mg). The study suggests that brotizolam (0.25 mg) is indicated for patients who have difficulty in falling asleep and staying asleep, and who must preserve their alertness during the early part of the next day. Flunitrazepam (2.0 mg) is equally effective, but at this dose there is a higher incidence of adverse effects.

RCT Entities:   Population Interventions Outcomes