From the Guidelines
The recommended dosage limit for melatonin is generally 10 mg per day for adults, though most people should start with a much lower dose of 0.5-3 mg taken 30-60 minutes before bedtime. For sleep issues, lower doses of 0.5-5 mg are typically effective and preferred [ 1 ]. Children should use even lower doses, ranging from 0.5-1 mg for young children to 1-3 mg for adolescents. Melatonin is a hormone naturally produced by the pineal gland that regulates sleep-wake cycles, and supplemental melatonin works by reinforcing these natural circadian rhythms.
Important Considerations
- Short-term use is generally considered safe, but long-term safety data is limited [ 1 ].
- Some people may experience side effects like headaches, dizziness, nausea, or daytime drowsiness, particularly at higher doses.
- It's best to use the lowest effective dose for the shortest duration needed.
- If sleep problems persist beyond a few weeks of melatonin use, consult a healthcare provider as this could indicate an underlying condition requiring different treatment.
Special Populations
- Children and adolescents:
- Start with lower doses (0.5-1 mg for young children, 1-3 mg for adolescents) [ 1 ].
- Monitor closely for side effects and adjust dose as needed.
- Pregnant or breastfeeding women:
- Consult a healthcare provider before using melatonin, as safety data is limited [ 1 ].
- Patients with underlying medical conditions:
- Consult a healthcare provider before using melatonin, as it may interact with other medications or worsen certain conditions [ 1 ].
From the FDA Drug Label
PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label Safrel Melatonin 3mg Tablets: The FDA drug label does not answer the question.
From the Research
Melatonin Dosage Limit
The recommended dosage limit for melatonin varies depending on the individual and the specific condition being treated.
- Studies have shown that daily doses of melatonin between 0.5 and 5mg are similarly effective for preventing or reducing jet-lag 2.
- Doses above 5mg appear to be no more effective for this purpose 2.
- For older adults, doses of melatonin between 1 mg and 6 mg appear to be effective for improving sleep 3.
- A study found that 5mg of melatonin significantly increased sleep efficiency during both biological day and night in older adults 4.
- Another study found that melatonin at low to moderate dosages (approximately 5-6 mg daily or less) appears safe 5.
Safety Considerations
- High-dose melatonin (≥10mg) has been found to increase the risk of adverse events such as drowsiness, headache, and dizziness 6.
- However, the overall safety profile of melatonin appears to be good, with limited adverse event reporting from high-dose melatonin studies 6.
- Long-term usage of melatonin has been found to be beneficial for certain patient populations, such as those with autism spectrum disorder 5.
- Further studies are needed to determine the optimal minimum effective dose of melatonin for improving sleep in older adults 3.