Melatonin Dosing Recommendations
Direct Answer by Clinical Indication
For adults with Delayed Sleep-Wake Phase Disorder (DSWPD), use 5 mg of melatonin taken between 19:00-21:00 (7-9 PM) for at least 28 days; for children with DSWPD without comorbidities, use 0.15 mg/kg taken 1.5-2.0 hours before habitual bedtime; and melatonin should NOT be used for chronic insomnia in adults as it provides no clinically significant benefit. 1, 2, 3
Adult Dosing Algorithm
Step 1: Identify the Sleep Disorder
For DSWPD (Delayed Sleep-Wake Phase Disorder):
- Administer 5 mg of melatonin between 19:00-21:00 (7-9 PM) for a minimum of 28 days 1, 2, 3
- This timing is critical: the dose must be given 1.5-2 hours before desired sleep onset, not at actual bedtime 2, 3
- This recommendation applies equally to adults with or without comorbid depression 1, 2
- Expected benefits include reduction in sleep latency by 37-44 minutes and increase in total sleep time by 41-56 minutes 1, 3
For Chronic Insomnia:
- Do NOT use melatonin - the American Academy of Sleep Medicine explicitly advises against melatonin for chronic insomnia based on trials showing no clinically significant benefit at 2 mg doses 2, 3
- The benefits were judged approximately equal to harms, with no improvements in sleep latency, total sleep time, wake after sleep onset, or sleep quality 2
- Consider FDA-approved hypnotics or cognitive behavioral therapy for insomnia (CBT-I) instead 2
Step 2: Dosing Considerations
Standard dosing range:
- Start with 3-5 mg for most sleep disorders 3
- Doses between 0.5-5 mg are similarly effective for DSWPD, except that 5 mg produces faster sleep onset and better sleep quality than 0.5 mg 1
- Doses above 5 mg appear no more effective and may cause receptor desensitization 3
- Maximum recommended dose is typically 12-15 mg, though doses above 10 mg risk receptor desensitization 3
Formulation matters:
- Use immediate-release melatonin, not slow-release formulations 1, 3
- The 2 mg slow-release formulation is relatively ineffective, suggesting that a short-lived higher peak concentration works better 1
Pediatric Dosing Algorithm
For Children with DSWPD WITHOUT Comorbidities:
Use weight-based dosing at 0.15 mg/kg taken 1.5-2.0 hours before habitual bedtime 1, 3
- This translates to approximately 4.4 mg for an average child in the studied population 1
- Treatment duration as short as 6 nights has demonstrated effectiveness 1, 3
- This represents moderate-quality evidence from randomized controlled trials 1
For Children with DSWPD WITH Psychiatric Comorbidities:
Use fast-release melatonin with weight-based approach: 3
- 3 mg if child weighs <40 kg
- 5 mg if child weighs >40 kg
- Administer at 18:00-19:00 for 4 weeks 3
General Pediatric Dosing Ranges:
Critical Timing Considerations
The timing of melatonin administration is as important as the dose itself:
- For DSWPD: administer between 19:00-21:00 or 1.5-2 hours before desired sleep time 1, 2, 3
- If taken at the wrong time (early in the day), melatonin causes sleepiness and delays adaptation to local time 5
- Maintain consistent nightly timing throughout the treatment period 1
Common Pitfalls and Caveats
Avoid these mistakes:
- Do not use melatonin for chronic insomnia - it is ineffective and represents inappropriate prescribing 2, 3
- Do not use slow-release formulations for sleep onset problems - they are less effective than immediate-release 1, 3
- Do not administer at bedtime - timing must be 1.5-2 hours before desired sleep 2, 3
- Do not exceed 5 mg for DSWPD unless treating other conditions, as higher doses offer no additional benefit and increase side effects 1, 3
Safety concerns:
- Exercise caution in patients taking warfarin due to potential interactions 3, 5
- Use caution in patients with epilepsy based on case reports of potential harm 3, 5
- Common mild side effects include morning headache, morning sleepiness, drowsiness, dizziness, and gastrointestinal upset 3, 6
- No serious adverse reactions have been documented across age groups when used at recommended doses 1, 3
Quality control:
- Choose United States Pharmacopeial Convention Verified formulations for most reliable dosing 3
- Many over-the-counter melatonin products have variable quality and actual melatonin content 3
Evidence Quality and Strength
The recommendation for DSWPD is based on low-to-moderate quality evidence but represents the strongest available data 1, 2, 3. The American Academy of Sleep Medicine provides a weak recommendation FOR melatonin in DSWPD but a weak recommendation AGAINST melatonin in chronic insomnia 1, 2, 3. This divergence reflects the condition-specific efficacy: melatonin works by resetting circadian rhythms in DSWPD but does not address the underlying pathophysiology of chronic insomnia 2.