Starting Dose of Melatonin for Adults
For adults, start with 3-5 mg of immediate-release melatonin if treating a circadian rhythm disorder like Delayed Sleep-Wake Phase Disorder, but do not use melatonin at all for chronic insomnia—it doesn't work. 1, 2, 3
Critical First Decision: What Are You Treating?
The starting dose depends entirely on the indication, as melatonin's efficacy varies dramatically by condition:
For Chronic Insomnia: DO NOT USE
- The American Academy of Sleep Medicine explicitly recommends AGAINST using melatonin for chronic insomnia in adults. 1, 3
- Trials using 2 mg doses showed no clinically significant benefit for sleep onset, maintenance, or quality—only a 9-minute reduction in sleep latency compared to placebo. 1, 3
- The evidence quality is very low, and benefits approximately equal harms. 1
- Instead, use FDA-approved hypnotics (zolpidem, eszopiclone) or cognitive behavioral therapy for insomnia (CBT-I). 1, 3
For Delayed Sleep-Wake Phase Disorder (DSWPD): START WITH 3-5 MG
- Begin with 3-5 mg of immediate-release melatonin taken between 19:00-21:00 (7-9 PM) for at least 28 days. 1, 2, 3
- The American Academy of Sleep Medicine specifically recommends 5 mg for this indication. 1, 2
- Timing is critical: administer 1.5-2 hours before desired sleep onset, NOT at bedtime. 1, 2
- This regimen reduced sleep latency by 38-44 minutes and increased total sleep time by 41-56 minutes in trials. 1
- This is a weak recommendation based on low-quality evidence, but represents the best available option. 1
For Non-24-Hour Sleep-Wake Rhythm Disorder (Blind Adults): START WITH 5 MG
- Use 5 mg taken either 1 hour before preferred bedtime or at a fixed time (21:00) for 26-81 days. 3
- This showed an odds ratio for entrainment of 21.18 (95% CI: 3.22-39.17). 3
Dosing Principles and Boundaries
Effective Dose Range
- The optimal therapeutic range for most circadian disorders is 3-5 mg. 3
- Doses between 0.5-5 mg are similarly effective for jet lag, except people fall asleep faster with 5 mg than 0.5 mg. 4
- Lower doses (0.3 mg) may work for daytime sleep but are less effective for nighttime sleep in older adults. 5
Maximum Dose Considerations
- The maximum recommended dose is 12-15 mg, reserved only for specific conditions like REM sleep behavior disorder (3-12 mg range). 2, 3
- Doses above 10 mg risk receptor desensitization with no additional benefit. 2, 3
- Higher doses (≥10 mg) increase adverse effects like drowsiness, headache, and dizziness without improving efficacy. 6
Formulation Matters
- Use immediate-release formulations, not slow-release. 1, 2
- Slow-release melatonin (2 mg) appears less effective than immediate-release for sleep onset. 2
- The 2 mg prolonged-release formulation showed minimal benefit even in elderly patients (>55 years). 2, 3
Special Population: Elderly Adults
- For elderly patients with insomnia, melatonin still should NOT be used based on American Academy of Sleep Medicine guidelines. 2, 3
- If treating a circadian disorder in elderly patients, use the same 3-5 mg dose as younger adults. 2, 3
- One study showed 5 mg increased sleep efficiency during both day and night in older adults (>55 years), primarily by increasing Stage 2 sleep. 5
Common Pitfalls to Avoid
Wrong Timing = Treatment Failure
- If taken early in the day at the wrong time, melatonin causes sleepiness and delays adaptation to local time. 3, 4
- For DSWPD, must take between 19:00-21:00, not at actual bedtime. 1, 2
Wrong Indication = Wasted Treatment
- Using melatonin for primary insomnia wastes time and delays effective treatment with FDA-approved hypnotics or CBT-I. 1, 3
Insufficient Treatment Duration
- Must continue for at least 28 days to assess efficacy in DSWPD. 1, 2
- Stopping too early may lead to false conclusion of treatment failure. 1
Safety Considerations
- No serious adverse reactions documented across age groups. 2, 3
- Common mild side effects include morning headache, morning sleepiness, and gastrointestinal upset. 2, 3
- Exercise caution in patients taking warfarin or with epilepsy due to potential interactions. 2, 3
- Choose reputable formulations (United States Pharmacopeial Convention Verified) for reliable dosing. 2
Practical Starting Algorithm
Step 1: Identify the condition
- Chronic insomnia → Do NOT use melatonin; use FDA-approved hypnotics or CBT-I 1, 3
- DSWPD or circadian rhythm disorder → Proceed to Step 2 1, 2
Step 2: Start 3-5 mg immediate-release melatonin
- Administer between 19:00-21:00 (or 1.5-2 hours before desired sleep time) 1, 2, 3
- Continue for minimum 28 days before assessing efficacy 1, 2
Step 3: If inadequate response after 28 days