Effects of brotizolam, flurazepam and placebo upon nocturnal auditory arousal thresholds.

Auditory awakening thresholds (AAT) and the back-to-sleep latency (BSL) after nocturnal awakenings from Stage 2 sleep were studied in normal male subjects after placebo, brotizolam (0.25, 0.375 and 0.50 mg) and flurazepam (30 mg). AAT (dB) was measured in five trials spaced across the night in a 'double awakening' procedure with the second awakening in each trial made from Stage 2 sleep. Each drug condition was associated with elevated mean AAT across the five trials in comparison with placebo. In a trial-by-trial analysis only 0.50 mg brotizolam and 30 mg flurazepam were consistently higher in the first three trials compared with placebo. All active drug conditions decreased the mean BSL across all trials in comparison with placebo, but only 30 mg flurazepam and 0.50 mg brotizolam consistently shortened BSL in the first three trials. Brotizolam (0.50 mg) and 30 mg flurazepam are similar in their effects. The subjective improvement reported in insomniac subjects following hypnotic administration may be related to elevation in arousal thresholds and a quick return to sleep after nocturnal sleep disruption.

RCT Entities:   Population Interventions Outcomes