The influence on objective and subjective sleep variables and tolerance of lofepramine (140 mg) given as a single night time dose was compared with placebo in a double-blind cross-over study. Four healthy male volunteers on the same 2 nights of 2 consecutive weeks took either lofepramine or placebo in a randomized order. On 2 successive mornings of the third week all subjects took 140 mg lofepramine after breakfast. The main variables were electrophysiological measures of all night sleep. Supplementary, scores on a sleep questionnaire after each night, and scores on a side-effect questionnaire every morning and evening of the experiment were obtained. Lofepramine reduced paradoxical sleep and increased REM latency. There was a tendency for more intra-sleep restlessness but no relevant changes in sleep continuity variables. In these subjects lofepramine did not change subjective judgement of sleep quality and of feeling refreshed after sleep. No side-effects were reported.
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