Abstract
Study Objectives To investigate the efficacy of melatonin compared to placebo in improving sleep parameters in patients with primary sleep disorders. Design PubMed was searched for randomized, placebo-controlled trials examining the effects of melatonin for the treatment of primary sleep disorders. Primary outcomes examined were improvement in sleep latency, sleep quality and total sleep time. Meta-regression was performed to examine the influence of dose and duration of melatonin on reported efficacy. Participants Adults and children diagnosed with primary sleep disorders. Interventions Melatonin compared to placebo. Results Nineteen studies involving 1683 subjects were included in this meta-analysis. Melatonin demonstrated significant efficacy in reducing sleep latency (weighted mean difference (WMD) = 7.06 minutes [95% CI 4.37 to 9.75], Z = 5.15, p < 0.001) and increasing total sleep time (WMD = 8.25 minutes [95% CI 1.74 to 14.75], Z = 2.48, p < 0.013). Trials with longer duration and using higher doses of melatonin demonstrated greater effects on decreasing sleep latency and increasing total sleep time. Overall sleep quality was significantly improved in subjects taking melatonin (standardized mean difference = 0.22 [95% CI: 0.12 to 0.32], Z = 4.52, p < 0.001) compared to placebo. No significant effects of trial duration and melatonin dose were observed on sleep quality. Conclusion This meta-analysis demonstrates that melatonin decreases sleep onset latency, increases total sleep time and improves overall sleep quality. The effects of melatonin on sleep are modest but do not appear to dissipate with continued melatonin use. Although the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile compared to these agents. (Reprinted with permission from PLOS ONE 2013; 8(5):1–6)
Highlights
Primary sleep disorders are those not associated with a medical condition, substance use or concurrent psychological disorder
Melatonin demonstrated significant efficacy in reducing sleep latency (weighted mean difference (WMD) = 7.06 minutes [95% CI 4.37 to 9.75], Z = 5.15, p,0.001) and increasing total sleep time (WMD = 8.25 minutes [95% CI 1.74 to 14.75], Z = 2.48, p = 0.013)
Overall sleep quality was significantly improved in subjects taking melatonin compared to placebo
Summary
Primary sleep disorders are those not associated with a medical condition, substance use or concurrent psychological disorder. In order to be diagnosed with a primary sleep disorder, the sleep disturbance must cause significant distress or impairment in social, occupational, or other areas of functioning [1]. Nine percent of Americans report having insomnia [2]. Thirty-five to forty percent of Americans report having problems falling asleep or excessive daytime sleepiness [3]. Primary sleep disorders are often comorbid with psychiatric disorders, neurological and cardiovascular diseases [4]. Average medical expenses of individuals with insomnia in the United States is nearly $2000 greater annual than those without sleep problems [5]. Poor sleep is associated with an increased risk of mortality, hospitalization and traffic accidents [6,7,8]
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