What is the recommended approach for using melatonin (melatonin) to treat sleep difficulties?

Melatonin for Sleep Difficulties

The American Academy of Sleep Medicine recommends against using melatonin for chronic insomnia in adults, though it may be considered for specific circadian rhythm disorders at doses of 3-5 mg taken 1.5-2 hours before bedtime. 1

Primary Insomnia: Not Recommended

The 2017 American Academy of Sleep Medicine clinical practice guideline explicitly suggests that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia in adults. 1 This weak recommendation is based on:

• Very low quality evidence showing minimal efficacy at 2 mg doses 1
• Benefits approximately equal to harms 1
• More effective alternatives available (zolpidem, ramelteon, temazepam) 1

The guideline notes that while the majority of patients would not use melatonin over no treatment, many still would—reflecting the equivocal nature of the evidence. 1

When Melatonin May Be Appropriate

Circadian Rhythm Sleep Disorders

Melatonin has a more established role for delayed sleep-wake phase disorder and other circadian rhythm disturbances rather than primary insomnia:

• Adults with DSWPD: 5 mg taken between 19:00-21:00 for 28 days 2
• Children without comorbidities: 0.15 mg/kg taken 1.5-2 hours before habitual bedtime 2
• Children with psychiatric comorbidities: 3 mg if <40 kg or 5 mg if >40 kg 2

Elderly Patients (Special Consideration)

In elderly patients (>55 years) with documented low melatonin production, prolonged-release melatonin 2 mg may provide modest benefit, though evidence quality remains low. 1, 3 The 2009 American Geriatrics Society guidelines note this may be most effective in elderly insomniacs chronically using benzodiazepines or with documented low nocturnal melatonin levels. 1

Optimal Dosing Strategy

Start low and go slow—lower doses may actually be more effective than higher doses:

• Initial dose: 3 mg immediate-release melatonin 4, 2
• Timing: 1.5-2 hours before desired bedtime 4, 2
• Titration: If ineffective after 1-2 weeks, increase by 3 mg increments 4
• Maximum dose: 15 mg (doses above 10 mg may cause receptor desensitization) 4, 2

The rationale for lower dosing: Higher doses (10 mg) may cause receptor saturation and desensitization, disrupting normal circadian signaling mechanisms. 4 Clinical trials show more frequent adverse effects (morning headache, sleepiness) with higher doses. 4

Important Safety Considerations

Adverse Effects

• Morning grogginess and "hangover" effects more common with higher doses 4
• Gastrointestinal upset reported at higher doses 4
• Impaired motor function possible with excessive dosing 4

Drug Interactions and Contraindications

• Use caution in patients taking warfarin 4, 2
• Use caution in patients with epilepsy 4, 2
• Avoid in older adults with dementia and irregular sleep-wake rhythm disorder (detrimental effects on mood and daytime functioning observed) 4

Product Quality Concerns

Melatonin is regulated as a dietary supplement in the US, raising concerns about purity and reliability of stated doses. 1, 4 Choose United States Pharmacopeial Convention Verified formulations when possible for more reliable dosing. 4, 2

Long-Term Use: Not Recommended

The American Academy of Sleep Medicine explicitly states that long-term use of melatonin for chronic insomnia is not recommended because efficacy and safety data is limited to short-term studies. 4 Safety and efficacy in long-term treatment remains unknown. 4

If long-term use is necessary for circadian rhythm disorders:

• Periodic attempts to reduce frequency and dose every 3-6 months 4
• Consider tapering to every other or every third night rather than daily use 4
• Taper gradually over several weeks to months if discontinuing after prolonged use 4

Critical Care Setting

In critically ill adults, the 2018 Critical Care Medicine guidelines make no recommendation regarding melatonin use due to very low quality evidence from small trials showing no discernible difference in sleep duration. 1

Clinical Algorithm

For primary insomnia in adults:

1. Do not use melatonin as first-line treatment 1
2. Consider FDA-approved alternatives (zolpidem, ramelteon, temazepam) 1
3. Implement cognitive-behavioral therapy for insomnia 1

For circadian rhythm disorders:

1. Start with 3 mg immediate-release melatonin 4, 2
2. Administer 1.5-2 hours before desired bedtime 4, 2
3. Assess response after 1-2 weeks 4
4. If ineffective, increase by 3 mg increments up to maximum 15 mg 4
5. Reassess need for continued therapy every 3-6 months 4

For elderly patients with documented low melatonin:

1. Consider 2 mg prolonged-release formulation 1, 3
2. Particularly if chronically using benzodiazepines 3
3. Monitor for morning sedation and falls risk 1