A METHOD FOR THE EVALUATION OF HYPNOTIC AGENTS IN MAN. THE COMPARATIVE HYPNOTIC EFFECTS OF SECOBARBITAL, METHAQUALONE AND A PLACEBO IN NORMAL SUBJECTS AND IN PSYCHIATRIC PATIENTS

¹ Departments of Pharmacology and Psychiatry, Faculty of Medicine, University of Montreal, Montreal, Canada

Comparative drug trials were performed in 40 normal volunteer medical students and 27 psychiatric patients with insomnia in an attempt to determine the predictive value of hypnotic efficacy data obtained in normal volunteers for patients with insomnia. The same drugs and investigators and similar methods were used in both trials. The comparative effects of randomly administered secobarbital (100 and 200 mg), methaqualone (150 and 300 mg or 300 mg alone) and a placebo on induction and maintenance of sleep and on reawakening were studied by means of subjective evaluations, i.e., self-responding and interview questionnaires, using a double-blind, cross-over design. Both normal subjects and psychiatric patients with insomnia reported secobarbital (200 mg) effective in rapidly inducing and prolonging sleep and in suppressing disturbing dream recall. In contrast, normal volunteers, but not psychiatric patients, had significant hangover effect with this drug. Neither the normal subjects nor patients with insomnia found the effects of methaqualone (150 or 300 mg) distinguishable from those of the placebo. Briefly, in these two widely different populations, the comparative hypnotic effects of the forms of treatment tested were very similar, but the hangover effects were not. Therefore the experimental data on the efficacy of hypnotic drugs in normal subjects were predictive of results observed in patients with insomnia and imply that normal volunteers might be useful subjects in the early clinical evaluation of new drugs with potential hypnotic activity.