A Method for the Evaluation of Hypnotics in Man.

IN THIS study, the principle of using a physiological fluid load to produce a disturbance in the sleep of normal subjects has been utilized both for the evaluation of the non-barbiturate hypnotic, ethchlorvynol ('Arvynol': Pfizer) and to compare its hypnotic effect with glutethimide ('Doriden': Ciba). The technique, which is based on the work of Isaacs (1957 a,b.) and Condouris, Costa and Bonnycastle (I960), has been adapted to provide a simple reproducible method for evaluating and comparing hypnotics in man. Ethchlorvynol, ethyl-p-chlorovinyl ethinyl carbinol, has been shown to produce hypnotic effects in animals (P'An, Kodet, Gardocki, McLamore and Bavley, 1955) and to be as effective as glutethimide (Cuthbert, I963) thalidomide, butobarbitone (Woodd-Walker, I963) and dichloralphenazone (Tsapogas, Modle & Wheeler, I962) in clinical trial.In addition, when compared with an equivalent dose of thalidomide in rabbits, ethchlorvynol produced no teratogenic effects whereas thalidomide in the same experiment produced either stillbirth or teratogenic effects in the great majority of the offspring (Reinert, I962). No effect on the human fcetus has been noted in the U.S.A. where this hypnotic has been available for over 6 years.