Maximum Recommended Dose of Melatonin
The maximum recommended dose of melatonin is 15 mg, though lower doses (3-5 mg) are often more effective and should be tried first before escalating to higher doses. 1
Dosing Recommendations by Age Group
- For adults with sleep disorders, start with 3 mg of immediate-release melatonin, with dose titration in 3 mg increments only if needed, up to a maximum of 15 mg 1
- For elderly patients (>55 years), a lower dose of 2 mg prolonged-release melatonin has shown benefit 2
- For children with Delayed Sleep-Wake Phase Disorder (DSWPD) without comorbidities, a weight-based dose of 0.15 mg/kg is recommended 2
- For children with DSWPD and psychiatric comorbidities, 3-5 mg is recommended (3 mg if <40 kg and 5 mg if >40 kg) 1, 2
Optimal Dosing Considerations
- Lower doses of melatonin (0.3-3 mg) are often more effective than higher doses for phase advancement and sleep improvement 1, 3
- Higher doses (10 mg+) may cause receptor desensitization or saturation, potentially disrupting normal circadian signaling mechanisms 1
- For REM sleep behavior disorder, doses range from 3-12 mg at bedtime 4
- In elderly insomniacs, doses between 1-6 mg appear effective for improving sleep 5
Timing of Administration
- Administer melatonin 1.5-2 hours before desired bedtime for optimal effect 1, 2, 3
- For adults with DSWPD, administration between 19:00-21:00 for 28 days is recommended 2
- Consistency in timing is crucial for effectiveness 3
Safety Considerations
- No serious adverse reactions have been documented with melatonin use across age groups 1, 2
- Higher doses (≥10 mg) may increase risk of mild adverse effects such as drowsiness, headache, and dizziness 6
- Morning grogginess and "hangover" effects are more commonly reported with higher doses 1
- Gastrointestinal upset occurs more frequently at higher melatonin doses 1
Formulation Considerations
- Immediate-release formulations appear more effective than slow-release formulations for sleep onset 2, 3
- Choose United States Pharmacopeial Convention Verified formulations when possible for more reliable dosing 1, 3
Special Populations and Precautions
- Use with caution in patients taking warfarin or those with epilepsy due to potential interactions 1, 2
- Patients with liver disease may experience enhanced sensitivity to melatonin, making lower doses more appropriate 1
- Concurrent medications may interact with melatonin metabolism, potentially amplifying effects of higher doses 1
Dose Escalation Algorithm
- Start with 3 mg of immediate-release melatonin taken 1.5-2 hours before desired bedtime 1, 2
- Assess response after 1-2 weeks of consistent use 1
- If ineffective and no adverse effects, increase by 3 mg increments 1
- Continue dose escalation as needed, up to a maximum of 15 mg 1
- If adverse effects occur, return to the previous well-tolerated dose 1