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.

Comparative study on the efficacy of and the tolerance to the triazolodiazepines, triazolam and brotizolam.

Efficacy of and tolerance to 0.25 mg brotizolam and 0.25 mg triazolam were compared in hospitalised patients (aged 20 to 69 years) with sleep difficulties. Over 6 days there were no differences in efficacy and tolerance. The physicians reported the effectiveness of the drugs as good-to-satisfactory in 88.6% with brotizolam and 92.0% with triazolam. The patients reported with both drugs reduced time to fall asleep, less awakenings, increased duration of sleep and improved condition on awakening.