Melatonin Dosing Recommendations
For circadian rhythm disorders like delayed sleep-wake phase disorder, use 3-5 mg of immediate-release melatonin taken between 19:00-21:00 for adults, or 0.15 mg/kg taken 1.5-2 hours before bedtime for children; however, melatonin should NOT be used for chronic insomnia as first-line therapy due to minimal efficacy. 1, 2
Primary Insomnia: Not Recommended
- The American Academy of Sleep Medicine explicitly recommends AGAINST using melatonin for chronic insomnia in adults due to minimal efficacy—only a 9-minute reduction in sleep latency compared to placebo. 2
- Melatonin performs poorly for sleep onset or maintenance insomnia, with very low quality evidence supporting its use. 2, 3
- If treating primary insomnia, use FDA-approved hypnotics (zolpidem, eszopiclone) instead of melatonin. 2
Delayed Sleep-Wake Phase Disorder (DSWPD)
Adults with DSWPD
- Start with 3-5 mg immediate-release melatonin taken between 19:00-21:00 for at least 28 days. 1, 2, 3
- This regimen increased total sleep time by 56 minutes and decreased sleep latency by 37.7 minutes in non-depressed adults. 1, 3
- The timing window of 19:00-21:00 is critical—taking melatonin at the wrong time (morning/afternoon) worsens circadian misalignment. 2, 4
Children with DSWPD (No Comorbidities)
- Use weight-based dosing: 0.15 mg/kg taken 1.5-2.0 hours before habitual bedtime for at least 6 nights. 1, 2, 3
- This dose showed optimal results in children aged 6-12 years with moderate quality evidence. 1
- For a 30 kg child, this equals approximately 4.5 mg. 1
Children with DSWPD and Psychiatric Comorbidities
- Give 3 mg if <40 kg or 5 mg if ≥40 kg, administered at 18:00-19:00 for 4 weeks. 2, 3
- This applies to children with autism spectrum disorders or other psychiatric conditions. 3
Elderly Patients
- Prolonged-release melatonin 2 mg taken 1-2 hours before bedtime may provide modest benefit for elderly insomniacs (≥55 years), though evidence quality is low. 1, 3, 5
- The American Academy of Sleep Medicine's recommendation against melatonin for primary insomnia still applies to elderly patients. 2, 3
- Elderly patients with documented low melatonin levels or those chronically using benzodiazepines may respond better. 6
- Treatment duration of 3-12 weeks is recommended for elderly patients. 5
Jet Lag
- Take 0.5-5 mg melatonin close to target bedtime (22:00-midnight) at the destination for flights crossing 5 or more time zones. 7
- Daily doses between 0.5-5 mg are similarly effective, though 5 mg helps people fall asleep faster than 0.5 mg. 7
- The number needed to treat is 2, making this remarkably effective. 7
- Benefit is greater for eastward flights and when crossing more time zones. 7
- Timing is critical: taking melatonin early in the day causes sleepiness and delays adaptation to local time. 7
Shift-Work Sleep Disorder
- No high-quality guideline evidence was provided for shift-work disorder dosing.
- Based on circadian principles, 3-5 mg taken before the desired sleep period would be reasonable, though this extrapolates from DSWPD data. 2
Dose Escalation and Maximum Dosing
- If 3 mg is ineffective after 1-2 weeks, increase by 3 mg increments up to a maximum of 10-15 mg. 2, 4
- The typical effective range is 3-5 mg for most adults. 2, 3
- Doses above 10 mg risk receptor desensitization with no additional benefit. 2, 3
- Lower doses (0.5-3 mg) can paradoxically be more effective than higher doses due to receptor physiology. 4
Formulation Selection
- Immediate-release formulations are more effective than slow-release for sleep onset. 3, 4, 7
- Slow-release 2 mg melatonin showed relative ineffectiveness compared to immediate-release in DSWPD trials. 1
- Choose United States Pharmacopeial Convention (USP) Verified formulations when possible for reliable dosing and purity. 4
Safety Precautions and Contraindications
- Use extreme caution in patients taking warfarin—documented case reports show potential interactions. 4, 7
- Exercise caution in patients with epilepsy based on case reports. 1, 4, 7
- Monitor for impaired glucose tolerance in patients with diabetes risk factors. 4
- Common mild side effects include morning headache, morning sleepiness, and gastrointestinal upset. 2, 3
- No serious adverse reactions have been documented across age groups in short-term use. 1, 2, 3
- Avoid long-term use beyond 3-4 months for chronic insomnia due to insufficient safety data. 4
Critical Pitfalls to Avoid
- Do not use melatonin as first-line treatment for chronic insomnia—the evidence is weak and FDA-approved hypnotics are superior. 2, 4
- Do not take melatonin in the morning or afternoon except for specific circadian disorders—this worsens circadian misalignment. 4, 7
- Avoid alcohol consumption and excessive caffeine after 14:00 as these interact with melatonin. 4
- Do not use in elderly patients with dementia and irregular sleep-wake rhythm disorder—evidence shows potential harm. 1
- Medications like tricyclic antidepressants, MAOIs, and SSRIs can induce or exacerbate REM sleep behavior disorder when combined with melatonin. 1
Special Populations
Non-24-Hour Sleep-Wake Rhythm Disorder (Blind Adults)
- Use 0.5-10 mg melatonin taken either 1 hour before preferred bedtime or at a fixed time (21:00) for 26-81 days. 2
- This shows an odds ratio for entrainment of 21.18 (95% CI: 3.22-39.17). 2
REM Sleep Behavior Disorder
- Doses of 3-12 mg at bedtime are used, though clonazepam remains first-line. 1, 3
- Melatonin has good efficacy on clinical symptoms and is well tolerated. 5
Alzheimer's Disease and Mild Cognitive Impairment
- Use 2-5 mg or up to 10 mg as add-on treatment for sleep disorders, prescribed as early as possible for long periods. 5
- Light therapy used 12 hours before melatonin has positive synergistic effects. 5
- May have beneficial effects on cognitive function in MCI but shows no effect in moderate to severe Alzheimer's disease. 5