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lüll The efficacy and safety of exogenous melatonin for primary sleep disorders A meta-analysis Buscemi N; Vandermeer B; Hooton N; Pandya R; Tjosvold L; Hartling L; Baker G; Klassen TP; Vohra SJ Gen Intern Med 2005[Dec]; 20 (12): 1151-8BACKGROUND: 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).|Humans[MESH]|Hypnotics and Sedatives/*therapeutic use[MESH]|Melatonin/*therapeutic use[MESH]|Sleep Wake Disorders/*drug therapy[MESH]|Treatment Outcome[MESH] |