None of the authors have any conflicts of interest to declare.
The Efficacy and Safety of Exogenous Melatonin for Primary Sleep Disorders
Article first published online: 20 SEP 2005
Journal of General Internal Medicine
Volume 20, Issue 12, pages 1151–1158, December 2005
How to Cite
Buscemi, N., Vandermeer, B., Hooton, N., Pandya, R., Tjosvold, L., Hartling, L., Baker, G., Klassen, T. P. and Vohra, S. (2005), The Efficacy and Safety of Exogenous Melatonin for Primary Sleep Disorders. Journal of General Internal Medicine, 20: 1151–1158. doi: 10.1111/j.1525-1497.2005.0243.x
- Issue published online: 22 DEC 2005
- Article first published online: 20 SEP 2005
- Received for publication June 20, 2005 , and in revised form July 22, 2005 , Accepted for publication July 25, 2005
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).