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Melatonin for Insomnia: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines

Last updated: February 22, 2019
Project Number: RC1073-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of melatonin for the treatment of insomnia in adults?
  2. What is the cost-effectiveness of melatonin for the treatment of insomnia in adults?
  3. What are the evidence-based guidelines regarding the use of melatonin for the treatment of insomnia in adults?

Key Message

Evidence of limited quality from four systematic reviews and two randomized controlled trials suggested modest favourable effects of melatonin on global sleep outcomes, specific sleep outcomes, and outcomes related to functioning and mood, as well as unclear effects on quality of life for adults with primary and comorbid insomnia. Evidence from one systematic review showed no statistical difference between melatonin and placebo for safety outcomes. No evidence-based guidelines or evidence regarding the cost-effectiveness of melatonin for the treatment of insomnia were identified.