Starting Dose for Melatonin
The recommended starting dose for melatonin is 3 mg of immediate-release formulation, taken 30-60 minutes before bedtime. 1
Adult Dosing Algorithm
For most adults with sleep disorders, begin with 3 mg of immediate-release melatonin. 1 The American Academy of Sleep Medicine specifically recommends this starting dose, with titration in 3 mg increments if needed after 1-2 weeks of treatment. 1, 2
Dose Escalation Strategy
- If 3 mg is ineffective after 1-2 weeks, increase by 3 mg increments 2
- Maximum recommended dose is typically 12-15 mg 3, 2
- Lower doses (3-5 mg) are often more effective than higher doses due to receptor desensitization that can occur with doses of 10 mg or higher 2
Special Adult Populations
- For elderly patients (>55 years), prolonged-release melatonin at 2 mg has shown benefit, though evidence quality is considered low 1
- For REM sleep behavior disorder specifically, doses range from 3-12 mg at bedtime 3, 4
Pediatric Dosing Algorithm
For children, dosing depends on the presence of comorbidities:
Children WITHOUT Psychiatric Comorbidities
- Use weight-based dosing: 0.15 mg/kg 1, 2
- Administer 1.5-2.0 hours before habitual bedtime 1, 2
- This typically results in doses of 1.6-4.4 mg 2, 4
- Treatment duration as short as 6 nights has demonstrated effectiveness 1
Children WITH Psychiatric Comorbidities (including autism spectrum disorder)
- Use fixed dosing based on weight: 1, 2
- 3 mg if <40 kg
- 5 mg if >40 kg
- Administer at 18:00-19:00 1
- Continue for 4 weeks before assessing efficacy 1
Timing Considerations
Administration timing is critical for effectiveness:
- Take 30-60 minutes before desired bedtime for most sleep disorders 4
- For Delayed Sleep-Wake Phase Disorder specifically, take between 19:00-21:00 1
- Taking melatonin at the wrong time (early in the day) can cause sleepiness and delay adaptation to local time 5
Why Lower Doses May Be Superior
Starting with lower doses (3 mg) is preferable because higher doses can cause receptor desensitization or saturation, potentially disrupting normal circadian signaling. 2 Additionally:
- Morning grogginess and "hangover" effects are more common with higher doses due to melatonin's half-life extending into morning hours 2
- Gastrointestinal upset occurs more frequently at higher doses 2
- Immediate-release formulations are more effective than slow-release for sleep onset 1, 5
Safety Profile and Monitoring
No serious adverse reactions have been documented across age groups at recommended doses. 1, 2 However:
- Use caution in patients taking warfarin or those with epilepsy due to potential interactions 1, 2, 5
- Common mild side effects include morning headache, morning sleepiness, and gastrointestinal upset 3, 2
- Side effects are generally mild and resolve with medication cessation 6
Critical Formulation Considerations
Melatonin is regulated as a dietary supplement in the U.S., raising concerns about purity and reliability of stated doses. 2, 4
- Choose United States Pharmacopeial Convention Verified formulations when possible for more reliable dosing 1, 4
- Melatonin concentration varies widely between product labels and manufacturers 6
Common Pitfalls to Avoid
- Do not start with doses higher than 3-5 mg unless treating specific conditions like REM sleep behavior disorder 1, 2
- Avoid slow-release formulations for sleep onset issues, as immediate-release is more effective 1, 5
- Do not administer too early in the evening (before 19:00 for most patients), as this can worsen circadian misalignment 1, 5
- Do not assume higher doses are better—receptor desensitization makes this counterproductive 2