What is the maximum recommended dose of melatonin (melatonin) per day?

Maximum Recommended Dose of Melatonin

The maximum recommended dose of melatonin is 15 mg per day, which may be used in patients with REM Sleep Behavior Disorder after titrating up from an initial dose of 3 mg. 1

Dosage Recommendations by Population

Melatonin dosing varies significantly based on the patient population and condition being treated:

Adults

• General adults: 1-5 mg approximately 1-2 hours before bedtime 1
• Adults with Delayed Sleep-Wake Phase Disorder (DSWPD): 5 mg taken between 7:00-9:00 PM 1
• Patients with REM Sleep Behavior Disorder: Start with 3 mg at bedtime, may be titrated up to 15 mg if needed 1
• Elderly patients: Start with lower doses (1-2 mg) and titrate as needed 1

Children and Adolescents

• Children with DSWPD and no comorbidities: 0.15 mg/kg taken 1.5-2 hours before habitual bedtime 1
• Children with DSWPD and psychiatric comorbidities: 3-5 mg (weight-based) taken at 18:00 or 19:00 1
• Extended-release formulations may be considered for adolescents with neurodevelopmental disorders 1

Efficacy and Safety Considerations

Efficacy

• For jet lag: Doses between 0.5 and 5 mg are similarly effective, with 5 mg showing better sleep onset and quality than 0.5 mg 2, 3
• Doses above 5 mg do not appear to provide additional benefits for jet lag 2, 3
• Short-acting formulations with higher peak concentrations appear more effective than slow-release formulations 2, 3

Safety Profile

• Low to moderate doses (≤5-6 mg daily) appear generally safe for long-term use 4
• Higher doses (≥10 mg) may increase the risk of minor adverse events such as drowsiness, headache, and dizziness 5
• Short-term negative effects are typically minimal and resolve upon discontinuation 4

Special Precautions

Patient Populations Requiring Caution

• Patients with epilepsy: Case reports suggest potential harm 2, 3
• Patients taking warfarin: Potential interaction reported 2, 3
• Patients with hepatic impairment: Require special monitoring 1
• Children: Monitor for potential effects on growth hormone regulation and reproductive function/development 1

Timing Considerations

• Taking melatonin at the wrong time (early in the day) can cause sleepiness and delay adaptation to local time 2, 3
• Consistency in taking melatonin at the same time each night is crucial for reinforcing circadian rhythm 1

Monitoring Recommendations

• Regular monitoring for efficacy and side effects is essential 1
• Watch for adverse effects including:
  • Daytime drowsiness
  • Headache
  • Dizziness
  • Changes in mood
  • Potential hormonal effects with long-term use 1
• Periodic attempts to discontinue melatonin treatment should be made to assess continued need 1

Quality Control Issues

In the United States, melatonin is classified as a dietary supplement without regulatory oversight, leading to significant variation in concentration between products 4. This inconsistency should be considered when recommending specific doses.