Melatonin (Meloset) is NOT Recommended for Treating Insomnia
The American Academy of Sleep Medicine explicitly recommends against using melatonin for the treatment of either sleep onset or sleep maintenance insomnia in adults. 1
Evidence Against Melatonin Use
The guideline recommendation is based on very limited clinical benefit:
- Sleep latency reduction: Only 9 minutes greater than placebo (95% CI: 2 to 15 min reduction) 1
- Quality of sleep: Only small improvement compared to placebo 1
- Total sleep time: Not significantly improved 1
- Recommendation strength: WEAK, with very low quality of evidence 1
The clinical effect is so minimal that it does not justify routine use for chronic insomnia in adults. 1
Recommended Alternatives for Insomnia
For Both Sleep Onset AND Maintenance Insomnia:
For Sleep Onset Insomnia Only:
- Zaleplon 10 mg at bedtime 1, 2
- Triazolam 0.25 mg at bedtime 1, 2
- Ramelteon 8 mg at bedtime (melatonin receptor agonist, NOT melatonin itself) 1, 2, 3
For Sleep Maintenance Insomnia Only:
Important Clinical Caveats
All pharmacological recommendations for insomnia are rated as "WEAK" according to GRADE methodology, meaning that while benefits outweigh harms, many patients might reasonably choose not to use these treatments. 2
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the preferred first-line treatment and should be considered before or alongside any pharmacotherapy due to sustained benefits without tolerance or adverse effects. 2
When Melatonin Might Be Considered
While not recommended for primary insomnia, melatonin may have a role in:
- Circadian rhythm disorders (delayed sleep phase syndrome) using immediate release formulations <1 mg 4
- Neuropsychiatric disorders with comorbid insomnia (mood disorders, schizophrenia, autism spectrum disorders) using prolonged release 2-10 mg, 1-2 hours before bedtime 4
- Neurocognitive disorders and dementia with sleep disturbances, where 2-5 mg may improve sleep quality 5
However, these are distinct clinical scenarios from primary chronic insomnia in otherwise healthy adults. 4, 5
Dosing Information (If Used Off-Label)
If melatonin is prescribed despite guideline recommendations, typical dosing ranges are:
- Adults: 1-5 mg 6
- Elderly: 1-6 mg 6
- Prolonged release formulation: 2 mg, 1-2 hours before bedtime for 3-12 weeks 5
The FDA-labeled product shows 3 mg as a common over-the-counter dose. 7
Safety Profile
Melatonin demonstrates mild side effects at usual doses with no evidence of dependence even at high doses. 6 However, the lack of significant efficacy in primary insomnia outweighs any safety advantages. 1