A multi-centre, double-blind trial in general practice comparing the hypnotic efficacy and event profiles of flunitrazepam and temazepam.

Two hundred and ninety-nine patients requiring treatment for a sleep disturbance were recruited into a double-blind multi-centre trial by 47 doctors. Patients received either 1 mg flunitrazepam or 20 mg temazepam for from 7 to 14 days. Analysis of the results of assessment in 246 patients by doctors and patients indicated that flunitrazepam was significantly better than temazepam in the improvement of onset of sleep, reduction in nocturnal awakenings and early morning awakenings. The solicited event profiles of both treatments were similar and consistent with the low risk expected of a hypnotic.

RCT Entities:   Population Interventions Outcomes