Brotizolam: a sleep laboratory evaluation.

Brotizolam 0.25 mg was evaluated in a sleep laboratory study of 10 normal subjects. The study covered 10 consecutive nights and included 4 placebo-baseline nights, 3 nights on the drug and 3 placebo-withdrawal nights, which permitted assessment of initial drug effects, side effects and withdrawal phenomena, such as rebound insomnia. There was a significant increase in total sleep time with drug administration; the improvement in sleep occurred primarily in the first third of the night following the onset of sleep. During the day after nightly drug administration, the presence of rebound anxiety was suggested by an increase in reports of anxiety/tension as compared to baseline. Following drug withdrawal there was a significant increase in total wake time above baseline level, to 40% above baseline on the first and third nights of withdrawal.

RCT Entities:   Population Interventions Outcomes