Is Melatonin Recommended for Insomnia?
No, melatonin is not recommended for the treatment of chronic insomnia in adults due to insufficient efficacy and safety data. 1
Guideline-Based Recommendation
The American Academy of Sleep Medicine explicitly states that melatonin is not recommended for chronic insomnia treatment. 1 This recommendation is based on:
Lack of clinically significant benefit: Meta-analysis of 2 mg melatonin doses showed only a 9-minute reduction in sleep latency compared to placebo (95% CI: 2-15 minutes), with small improvement in subjective sleep quality but no meaningful impact on total sleep time or wake after sleep onset. 1
Insufficient evidence base: The 2008 and 2017 AASM guidelines consistently categorize melatonin alongside other herbal/nutritional substances as lacking adequate efficacy and safety data for chronic insomnia. 1
Benefits equal to harms: The risk-benefit profile does not favor melatonin use for this indication. 2
Recommended Treatment Alternatives
When pharmacotherapy is indicated for chronic insomnia, the evidence-based sequence is: 1
First-line: Short-intermediate acting benzodiazepine receptor agonists (zolpidem, eszopiclone, zaleplon, temazepam) or ramelteon 1
Second-line: Alternative BzRAs or ramelteon if initial agent unsuccessful 1
Third-line: Sedating antidepressants (trazodone, doxepin, mirtazapine), particularly when comorbid depression/anxiety exists 1
Cognitive-behavioral therapy for insomnia (CBT-I) should accompany pharmacotherapy whenever possible and represents the standard of treatment. 1
Important Caveats
When Melatonin IS Appropriate
Melatonin has a role in circadian rhythm disorders, not primary insomnia:
- Delayed Sleep-Wake Phase Disorder (DSWPD): Use 5 mg administered between 19:00-21:00 (1.5-2 hours before desired sleep onset) for minimum 28 days. 2 This showed 38-44 minute reduction in sleep latency and 41-56 minute increase in total sleep time. 2
Common Pitfall to Avoid
Do not confuse melatonin's role in circadian rhythm regulation with efficacy for chronic insomnia. 2 While melatonin is the endogenous hormone controlling sleep-wake cycles, exogenous supplementation does not translate to meaningful clinical benefit in primary insomnia patients. 1, 3
Quality of Evidence Considerations
The 2017 AASM guideline rated melatonin evidence as "very low quality," based primarily on trials in adults >55 years using 2 mg doses. 1, 2 Even studies showing some objective improvements (like one trial demonstrating reduced sleep latency in elderly patients) 4 did not change the overall recommendation against its use, as the clinical significance remained questionable and the evidence base too limited. 1