Double-blind evaluation of the safety and hypnotic efficacy of temazepam in insomniac outpatients.

1 Efficacy of temazepam 30 mg at night as an hypnotic was compared with placebo in 55 out-patients with insomnia. The study was double blind, with two comparable groups of patients established by random allocation. Placebo and medication were taken for 4 consecutive nights and sleep questionnaires were completed the next day. 2 Patients reported that temazepam was more effective than placebo in reducing the difficulty of falling asleep and improving sleep maintenance. They also indicated that they awoke less and were less disturbed by early morning awakenings reported as a group that the average duration of sleep was increased by 1 hour. 3 The patients receiving temazepam reported being more alert in the morning and for the entire day than with placebo.

RCT Entities:   Population Interventions Outcomes