What is the recommended dosage and treatment duration of melatonin for insomnia?

Melatonin for Insomnia: Dosage and Treatment Duration

Melatonin is not recommended for the treatment of sleep onset or sleep maintenance insomnia in adults, based on clinical trials of 2 mg doses. 1

Evidence-Based Recommendations

The American Academy of Sleep Medicine (AASM) provides a weak recommendation against using melatonin for insomnia treatment, with very low quality evidence suggesting that harms outweigh benefits 1. This recommendation is based on trials using 2 mg doses of melatonin, which failed to demonstrate sufficient efficacy for either sleep onset or maintenance insomnia.

Preferred Alternatives for Insomnia

Instead of melatonin, the AASM suggests the following medications for insomnia:

• For sleep onset insomnia:

  • Zolpidem 10 mg (5 mg in elderly)
  • Zaleplon 10 mg
  • Ramelteon 8 mg
  • Triazolam 0.25 mg

• For sleep maintenance insomnia:

  • Doxepin 3-6 mg
  • Eszopiclone 2-3 mg
  • Temazepam 15 mg
  • Suvorexant 10-20 mg 1, 2

Special Considerations for Melatonin Use

Despite the AASM's recommendation against melatonin for primary insomnia treatment, there are specific situations where melatonin may be considered:

1. Elderly patients: Melatonin prolonged release 2 mg has been studied specifically in patients aged ≥55 years and may improve sleep quality and latency in this population 3. Treatment duration in these studies was up to 13 weeks, with no evidence of dependence, tolerance, or withdrawal symptoms.

2. Hospital-acquired insomnia: Small doses of melatonin may be appropriate for inpatients when insomnia persists despite non-pharmacological interventions, particularly given its favorable safety profile compared to sedative-hypnotics 4.

3. Age-specific dosing: When melatonin is used (despite guideline recommendations against it), effective doses have been reported to vary by age group:

   • Children: 0.5-3 mg
   • Adolescents: 3-5 mg
   • Adults: 1-5 mg
   • Elderly: 1-6 mg 5

Important Clinical Considerations

• Melatonin has not demonstrated efficacy in improving total sleep time, sleep efficiency, or wake time after sleep onset in patients with age-related sleep-maintenance insomnia 6.

• Melatonin PR 2 mg has minimal effects on psychomotor functions, memory recall, or driving skills during the night or next morning, showing significantly less impairment compared to zolpidem 10 mg 3.

• The timing of administration is crucial - melatonin is typically taken 1-2 hours before bedtime to mimic natural secretion patterns 3.

Treatment Duration Considerations

While the AASM does not recommend melatonin for insomnia treatment, studies that have examined melatonin use suggest:

• Short-term use (3 weeks) has been studied for efficacy 3
• Longer-term use (up to 13 weeks) has been studied for safety 3
• For pharmacological treatments in general, the American College of Physicians recommends limiting treatment to 4-5 weeks 2

Monitoring and Follow-up

If melatonin is used despite guideline recommendations against it:

• Assess sleep parameters within 2-4 weeks of starting treatment 2
• Monitor for side effects, though these are generally mild with melatonin 5
• Consider referral to a sleep specialist if insomnia persists 2

Conclusion

While melatonin is widely available as an over-the-counter supplement, current clinical guidelines from the American Academy of Sleep Medicine do not support its use for treating insomnia in adults. Other pharmacological options with stronger evidence bases should be considered first for patients requiring medication for insomnia.