Comparison of the short-acting benzodiazepines midazolam and triazolam with placebo.

The hypnotic effect of midazolam (Dormicum, 15 mg) and triazolam (0.5 mg) were compared with each other and with a placebo. Their effects on the quality of dreams and of morning awaking were also evaluated. 30 out-patients were included in a double-blind cross-over study for a period of 11 consecutive nights in which the order of the drugs was randomized according to the Latin squares method. The active substances and the placebo were each administered in 3-night blocks separated from each other by an intercalary placebo night. On waking each morning the patients answered a questionnaire concerning the previous night. Some of the responses were recorded on a visual analogue scale. Midazolam and triazolam significantly decreased the latency of onset of sleep and the number of nocturnal and premature morning awakenings. The patients' overall impression of their night was better under the active drugs than under placebo. However, there were no differences between placebo and the benzodiazepines as far as side effects or the quality of dreams and of morning awakening were concerned. The two drugs had an identical effect on sleep latency, but under midazolam the patients woke more frequently during the night and slightly earlier in the morning, suggesting that the duration of action is shorter. The intercalary placebo nights were better after 3 nights of placebo than after 3 nights of benzodiazepine. This rebound effect was more marked after triazolam than after midazolam. In conclusion the two benzodiazepines were both effective and well tolerated but midazolam is slightly shorter acting and has slightly less rebound effect than triazolam.

RCT Entities:   Population Interventions Outcomes