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Eur Psychiatry. 1995;10:173s-9s. doi: 10.1016/0924-9338(96)80100-3.

Effects of hypnotics on sleep quality and daytime well-being. Data from a comparative multicentre study in outpatients with insomnia.

European psychiatry : the journal of the Association of European Psychiatrists

G Hajak, P Clarenbach, W Fischer, W Haase, B Bandelow, L Adler, E Rüther

Affiliations

  1. Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075 Göttingen, Germany.

PMID: 19698415 DOI: 10.1016/0924-9338(96)80100-3

Abstract

The effect of treatment (28 days) with zopiclone, triazolam, flunitrazepam and placebo on sleep quality and daytime well-being was proven in a randomised, double-blind, parallel group, multicentre study in private practice. Results of an exploratory statistic of treatment efficacy in a subgroup of 1,291 patients suffering from insomnia are presented. Patients met the following criteria: insomnia lasting at least four weeks and the presence of at least two of the following: 1) sleep latency >/= 45 minutes, 2) total sleep time /=3 times. Treatment efficacy was assessed according to the following factors: either a shortening of sleep latency by at least 15 minutes, or prolongation of total sleep time by at least 20%, or reduction of the number of nocturnal awakenings to three or less and a refreshed feeling in the morning as well as no impairment in daytime well-being due to tiredness or anxiety. The total response rate was markedly higher with zopiclone (42.3%; p = 0.0003) than with placebo (29.0%). Triazolam (36.6%; p = 0.0905) and flunitrazepam (33.1%; p = 0.3401) were also more effective than the placebo, but they both tended to have a lower response rate than with zopiclone (p = 0.1199 and 0.0151, respectively). Total response was found to be essentially a reflection of the response of the socially important parameter of daytime well-being. These results suggest that zopiclone is more effective in the treatment of insomnia than either triazolam or flunitrazepam. Since the response of daytime well-being to therapy was generally poor, this parameter embodies the next main therapeutic challenge in the treatment of patients with insomnia.

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