Polygraphic sleep recordings before and after the administration of flunitrazepam.

By means of polygraphic sleep recordings (EEG, EOG, EMG, ECG, EDG, Respirogram, Positogram), neurologic-psychologic investigation and questionnaires on subjective feeling, ten patients aged from 22 to 40 years (mean: 29 years), who suffered from irregular disturbances in falling asleep and in sleeping continuously, were examined over a period of ten consecutives nights. The first investigation night was reserved for adaptation of the patients and could therefore not be evaluated. On the following three evenings placebo (Placebo I) was given, then 2 mg of flunitrazepam for the ensuing three nights and placebo again (Placebo II) for the last three nights. Thus, 90 investigation nights could be evaluated. 1. Latency times until the patients fell asleep and up to the first deep sleep were reduced significantly by the active preparation. Latency times up to the first REM-phase were prolonged. 2. The frequency of nocturnal awakenings was lessened significantly. Thus, disturbances in sleeping continuously disappeared for the duration of the treatment. Duration of wakefulness after having woken during the night decreased considerably. 3. Duration of wakefulness during the total night was reduced considerably, deeper sleep stages, such as D (stage III) and E(stage IV) were prolonged. 4. Duration of the REM-phases was reduced slightly. This reduction was not significant according to the t-test. 5. According to these results, the preparation showed a clear effect. A placebo-effect can be excluded, since the improvements mentioned were not found when placebo was given before administration of the medication and afterwards (Placebo I and II). 6. When comparing our results to those of other authors, who described the effects of various preparations, we found that the substance flunitrazepam showed different effects.

RCT Entities:   Population Interventions Outcomes