Journal of General Internal Medicine

, Volume 20, Issue 12, pp 1151–1158 | Cite as

The efficacy and safety of exogenous melatonin for primary sleep disorders a meta-analysis

  • Nina BuscemiEmail author
  • Ben Vandermeer
  • Nicola Hooton
  • Rena Pandya
  • Lisa Tjosvold
  • Lisa Hartling
  • Glen Baker
  • Terry P. Klassen
  • Sunita Vohra
Clinical Review


BACKGROUND: Exogenous melatonin has been increasingly used in the management of sleep disorders.

PURPOSE: To conduct a systematic review of the efficacy and safety of exogenous melatonin in the management of primary sleep disorders.

DATA SOURCES: A number of electronic databases were searched. We reviewed the bibliographies of included studies and relevant reviews and conducted hand-searching.

STUDY SELECTION: Randomized controlled trials (RCTs) were eligible for the efficacy review, and controlled trials were eligible for the safety review.

DATA EXTRACTION: One reviewer extracted data, while the other verified data extracted. The Random Effects Model was used to analyze data.

DATA SYNTHESIS: Melatonin decreased sleep onset latency (weighted mean difference [WMD]: −11.7 minutes; 95% confidence interval [CI]: −18.2, −5.2)); it was decreased to a greater extent in people with delayed sleep phase syndrome (WMD: −38.8 minutes; 95% CI: −50.3, −27.3; n=2) compared with people with insomnia (WMD: −7.2 minutes; 95% CI: −12.0, −2.4; n=12). The former result appears to be clinically important. There was no evidence of adverse effects of melatonin.

CONCLUSIONS: There is evidence to suggest that melatonin is not effective in treating most primary sleep disorders with short-term use (4 weeks or less); however, additional large-scale RCTs are needed before firm conclusions can be drawn. There is some evidence to suggest that melatonin is effective in treating delayed sleep phase syndrome with short-term use. There is evidence to suggest that melatonin is safe with short-term use (3 months or less).

Key Words

melatonin sleep primary review 


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Copyright information

© Society of General Internal Medicine 2005

Authors and Affiliations

  • Nina Buscemi
    • 1
    Email author
  • Ben Vandermeer
    • 1
  • Nicola Hooton
    • 1
  • Rena Pandya
    • 1
  • Lisa Tjosvold
    • 1
  • Lisa Hartling
    • 1
  • Glen Baker
    • 2
  • Terry P. Klassen
    • 1
  • Sunita Vohra
    • 3
  1. 1.University of Alberta Capital Health Evidence-based Practice Centre, Department of PediatricsUniversity of AlbertaEdmontonCanada
  2. 2.Department of PsychiatryUniversity of AlbertaEdmontonCanada
  3. 3.Complementary and Alternative Research and Education Program, Department of PediatricsUniversity of AlbertaEdmontonCanada

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