Melatonin Therapy for Insomnia in Adults

Guideline Recommendations and Evidence Quality

The American Academy of Sleep Medicine recommends against using melatonin for insomnia due to very low quality evidence, with a weak recommendation based on trials using 2 mg doses 1
The American Academy of Sleep Medicine provides a weak recommendation against melatonin for sleep onset or maintenance insomnia in adults, based on very low quality evidence showing a modest benefit of approximately 19 minutes reduction in sleep latency compared to placebo in elderly patients 1

Start with 2 mg of prolonged-release melatonin taken 1-2 hours before bedtime, as this dose has the strongest evidence base in patients over 55 years and mimics normal physiological circadian rhythm, according to the American Academy of Sleep Medicine 1
The maximum dose studied is 5 mg, though most evidence supports 2 mg as optimal in elderly patients, with dose escalation only considered after 3 weeks of inadequate response, as recommended by the American Academy of Sleep Medicine 1

The American Academy of Sleep Medicine supports the use of low-dose doxepin 3-6 mg for sleep maintenance insomnia, which has stronger evidence (moderate quality) 1
The American Academy of Sleep Medicine supports the use of Ramelteon 8 mg (a melatonin receptor agonist) for sleep onset insomnia, which has more consistent efficacy data than melatonin itself 1
The American Geriatrics Society recommends cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment before any pharmacotherapy 3