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Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis

BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.38731.532766.F6 (Published 16 February 2006) Cite this as: BMJ 2006;332:385
  1. Nina Buscemi, research associate (nina.buscemi{at}ualberta.ca)1,
  2. Ben Vandermeer, statistician1,
  3. Nicola Hooton, project coordinator1,
  4. Rena Pandya, project manager1,
  5. Lisa Tjosvold, research librarian1,
  6. Lisa Hartling, administrative director1,
  7. Sunita Vohra, director2,
  8. Terry P Klassen, director1,
  9. Glen Baker, professor and chair3
  1. 1 University of Alberta/Capital Health Evidence-based Practice Centre, Department of Pediatrics, University of Alberta, Edmonton, AB, Canada T6G 2J3
  2. 2 Complementary and Alternative Research and Education Program, Department of Pediatrics, University of Alberta
  3. 3 Department of Psychiatry, University of Alberta
  1. Correspondence to: N Buscemi
  • Accepted 18 November 2005

Abstract

Objective To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder.

Data sources 13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003).

Study selection The efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials.

Quality assessment Randomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist.

Data extraction and synthesis One reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data.

Main results Six randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference −13.2 (95% confidence interval −27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (−1.0 (−2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less).

Conclusions There is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.

Footnotes

  • Embedded Image Search terms used are on bmj.com

    We thank the National Centre for Complementary and Alternative Medicine, National Institutes of Health for sponsoring this research, through the Agency for Healthcare Research and Quality. We are grateful to members of our technical expert panel for providing input on the direction and scope of the review. We are especially grateful to Manisha Witmans for her input on the manuscript.

  • Contributors NB planned, oversaw, and participated in all steps of the systematic review process and in writing and editing the manuscript. BV performed all statistical analyses and participated in writing and editing the manuscript. NH participated in most steps of the systematic review process and in writing and editing the manuscript. RP participated in all steps of the systematic review process and reviewed the manuscript. LT conducted the literature search, provided technological expertise for the inclusion process, and participated in editing the manuscript. LH participated in writing the proposal, provided methodological expertise, and participated in writing and editing the manuscript. SV participated in writing the proposal, provided methodological and content expertise, and participated in editing the manuscript. TK participated in writing the proposal, provided methodological expertise, and provided feedback on the manuscript. GB participated in writing the proposal, provided content expertise, and participated in writing and editing the manuscript. Michelle Tubman, Mia Lang, Maria Ospina, Victor Juorio, and Ellen Crumley were involved in study selection, quality assessment, and data extraction or entry. TK is guarantor.

  • Funding This study was conducted under contract to the Agency for Healthcare Research and Quality (contract No 290-02-0023), Rockville, MD, and support from the National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD. SV is supported by Agency for Healthcare Research and Quality (AHRQ), USA; Canadian Institutes of Health Research; Change Foundation; Department of Pediatrics; National Health Products Directorate, Health Canada; Ontario Mental Health Foundation; Stollery Children's Hospital and Foundation; The Hospital for Sick Children Foundation; and the University of Alberta. GB is supported by AHRQ; Canadian Institutes of Health Research; Canada Research Chairs Program; Stanley Foundation; University of Alberta Hospital Foundation; Bebensee Schizophrenia Research Fund; Davey Endowment; and Zyprexa Research Foundation. The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality, the National Center for Complementary and Alternative Medicine or the US Department of Health and Human Services.

  • Competing interests None declared.

  • Ethical approval Not required.

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