Sleep Medicine
Volume 7, Issue 5 , Pages 397-406, August 2006

Efficacy and safety of zolpidem-MR: A double-blind, placebo-controlled study in adults with primary insomnia

  • Thomas Roth

      Affiliations

    • Henri Ford Hospital, 2799 West Grand Boulevard Detroit, MI 48202, USA
    • ,
  • Christina Soubrane

      Affiliations

    • Henri Ford Hospital, 2799 West Grand Boulevard Detroit, MI 48202, USA
    • Clinical Development, sanofi-aventis Research Chilly Mazarin, France
    • Drs Soubrane and Titeux are employed by sanofi-aventis.
    • Corresponding Author InformationCorresponding author. Address: Henry Ford Sleep Disorders Center, 2799 West Grand Boulevard CFP-3, Detroit, MI 48202, USA. Tel.: +1 69 79 42 36; fax: +1 69 79 48 05.
    • ,
  • Laurence Titeux

      Affiliations

    • Clinical Biostatistics, sanofi-aventis Research Chilly Mazarin, France
    • Drs Soubrane and Titeux are employed by sanofi-aventis.
    • ,
  • James K. Walsh

      Affiliations

    • St Luke's Hospital 232 South Woods Mill Road, Chesterfield, MO 63017, USA
    • ,
  • on behalf of the Zoladult Study Group

Received 10 November 2005; received in revised form 11 April 2006; accepted 13 April 2006.

Abstract 

Background and purpose

To evaluate the clinical efficacy and safety of modified-release zolpidem (zolpidem-MR 12.5mg) for the treatment of primary insomnia in adults.

Patients and methods

Two hundred and twelve (123 women, 89 men; mean age 44.3±SD 3.0 years), Diagnostic and Statistical Manual of Mental Disorders—4th Edition (DSM-IV)-defined primary insomnia patients were randomized in a double-blind, placebo-controlled, parallel-group study. The study was completed by 192 patients. Patients received 3 weeks of nightly treatment with either zolpidem-MR 12.5mg or placebo, preceded and followed by two nights of single-blind placebo. The main outcome measures were mean polysomnographic (PSG) sleep parameters of nights 1/2 and nights 15/16 of double-blind treatment and daily subjective sleep estimates from sleep questionnaires to assess efficacy, and PSG parameters of nights 22 and 23 of single-blind placebo substitution to assess the effect of drug discontinuation.

Results

Relative to placebo, zolpidem-MR 12.5mg improved sleep maintenance by significantly reducing PSG wake time after sleep onset (WASO) during the first 6h of sleep as well as the number of awakenings. Consistent with the effects of standard zolpidem, zolpidem-MR also significantly reduced latency to persistent sleep, and significantly increased sleep efficiency, both at the beginning and after 2 weeks of double-blind treatment. There was no evidence of next-day residual effects as measured objectively by psychometric tests. Rebound insomnia on the first night after abrupt discontinuation resolved the following night. Overall, zolpidem-MR was well tolerated.

Conclusions

Zolpidem-MR 12.5mg is effective and safe in treating primary insomnia in adults and improves sleep maintenance, induction and duration of sleep.

Keywords: Primary insomnia, Modified-release zolpidem, Sleep maintenance, Hypnotic medication, Polysomnographic sleep parameters, Single-blind placebo

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PII: S1389-9457(06)00114-6

doi:10.1016/j.sleep.2006.04.008

Sleep Medicine
Volume 7, Issue 5 , Pages 397-406, August 2006

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