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

Published online by Cambridge University Press:  16 April 2020

G Hajak ,
P Clarenbach ,
W Fischer ,
W Haase ,
B Bandelow ,
L Adler  and
E Rüther
G Hajak
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
P Clarenbach
Affiliation:
Department of Neurology, Evangelisches Johannes-Krankenhaus, Bielefeld, Germany
W Fischer
Affiliation:
Rhone-Poulenc Rarer GmbH, Köln, Germany
W Haase
Affiliation:
Institute for Numeric Statistic, Köln, Germany
B Bandelow
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
L Adler
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
E Rüther
Affiliation:
Department of Psychiatry, University of Göttingen, von-Siebold-Str 5, 57075Göttingen, Germany
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Summary

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 ≤ 6 hours, and 3) nocturnal awakening ≥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.

Keywords

zopicloneflunitrazepamtriazolaminsomniasleep disorderhypnotics
Type
Research Article
Information
European Psychiatry , Volume 10 , Issue S3: Satellite Symposium to the AEP Congress , 1995 , pp. 173s - 179s
Copyright
Copyright © Elsevier, Paris 1995

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