Pharmacopsychiatry 2002; 35(5): 165-174
DOI: 10.1055/s-2002-34119
Original Paper

© Georg Thieme Verlag Stuttgart · New York

Trimipramine in Primary Insomnia: Results of a Polysomnographic Double-Blind Controlled Study

D. Riemann1 , U. Voderholzer1 , S. Cohrs2 , A. Rodenbeck2 , G. Hajak2 , E. Rüther2 , M. H. Wiegand3 , G. Laakmann4 , T. Baghai4 , W. Fischer5 , M. Hoffmann6 , F. Hohagen7 , G. Mayer8 , M. Berger1
  • 1Department of Psychiatry and Psychotherapy, University of Freiburg, Germany
  • 2Department of Psychiatry and Psychotherapy, University of Göttingen, Germany
  • 3Department of Psychiatry and Psychotherapy, Technical University of Munich, Germany
  • 4Department of Psychiatry, University of Munich, Germany
  • 5Aventis Pharma GmbH, Bad Soden, Germany
  • 6Department of Psychiatry, University of Erlangen-Nuremberg, Germany
  • 7Department of Psychiatry and Psychotherapy, University of Lübeck, Germany
  • 8Neurological Hospital Hephata, Schwalmstadt-Treysa, Germany
The study was supported and sponsored by Aventis Pharma GmbH, Bad Soden, Germany (formerly Rhône Poulenc Rorer GmbH, Cologne, Germany)
Further Information

Publication History

Received: 20. 8. 2001 Revised: 8. 3. 2002

Accepted: 8. 3. 2002

Publication Date:
18 September 2002 (online)

In recent years, sedating antidepressants have been increasingly used to treat primary insomnia. Up to now, only one open pilot study with trimipramine and one double-blind placebo-controlled study with doxepin have leant scientific support for this approach in treating primary insomnia.

In order to test the hypothesis that sedating antidepressants are useful in the treatment of primary insomnia, the effect of trimipramine on objectively and subjectively measured parameters of sleep was investigated in a double-blind placebo- and lormetazepam-controlled study in a sample of 55 patients with primary insomnia attending outpatient sleep-disorder clinics.

Trimipramine was selected since it has shown positive effects on sleep continuity with a lack of REM sleep suppression in studies on depressed patients and in one pilot study on patients with primary insomnia.

Trimipramine at an average dose of 100 mg over a period of 4 weeks significantly enhanced sleep efficiency, but not total sleep time (which had been the primary target variable) compared to placebo as measured by polysomnography. Changes in objective sleep parameters were paralleled by changes in subjective sleep parameters. Trimipramine did not suppress REM sleep. Lormetazepam decreased wake time and sleep stage 3 and increased REM sleep compared to placebo.

After switching trimipramine to placebo, sleep parameters returned to baseline. There was no evidence of any rebound effect from trimipramine. Side effects from trimipramine were only marginal.

This first double-blind placebo-controlled study with trimipramine suggests its efficacy in the treatment of primary insomnia. However, due to the large intra- and interindividual variance in the parameters of interest before and during treatment a larger sample size would have been necessary to strengthen the validity of our findings.


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Prof. Dr. Dieter Riemann

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University of Freiburg

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