A Double-Blind Controlled Trial of S-1530 in Patients with Insomnia

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In a controlled double-blind study the hypnotic effect of S-1530 (5 mg q.d. for 7 consecutive nights) was investigated in comparison with that of nitrazepam (5mg) and a matching placebo in a series of 156 insomniac patients divided into three groups. Twenty-one eventually dropped out, then data were analyzed for evidence of hypnotic efficacy.<BR>By the Kruskal-Wallis H-test, there was no evidence of significant difference in effectiveness of drugs among the three groups according to global judgement by the physicians.<BR>The data were further assessed among the three groups by Discrimination Analysis (one of Multi-variate Analysis). No statistically significant difference was demonstrated among the three regimens in hypnotic efficacy of the initial dose, nor in promptness of effect, whereas both S-1530 and nitrazepam were significantly more effective than placebo on day 7 of medication with respect to induction and depth of sleep, number of awakenings before rising, dreaming, and feeling or mood on the following morning. It is suggested from the findings that the moode-levating and tranquilizing effects of S-1530, as well as nitrazepam, were beneficial at least partly in inducing and deepening sleep. The stochastical test, however, failed to reveal any significant difference in efficacy between S-1530 and nitrazepam. Nor was there significant difference among the three regimens with regard to incidence of side effects.
一般社団法人日本臨床薬理学会の論文

A Double-Blind Controlled Trial of S-1530 in Patients with Insomnia

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