From the Guidelines
Melatonin should be dosed between 0.5-5 mg for adults, with a starting dose of 3 mg taken at bedtime, as recommended by the most recent and highest quality study 1. When considering melatonin dosing, it's essential to prioritize the patient's specific needs and conditions.
- For sleep onset insomnia, lower doses (0.5-1 mg) are often effective, while sleep maintenance issues may require slightly higher doses (2-5 mg).
- Children generally need lower doses, ranging from 0.5-3 mg based on age and weight.
- Extended-release formulations are better for maintaining sleep throughout the night, while immediate-release forms help with falling asleep. The American Academy of Sleep Medicine recommends melatonin for the treatment of intrinsic circadian rhythm sleep-wake disorders, including advanced sleep-wake phase disorder, delayed sleep-wake phase disorder, non-24-hour sleep-wake rhythm disorder, and irregular sleep-wake rhythm disorder 2, 3. Melatonin works by binding to receptors in the brain that regulate the sleep-wake cycle, reinforcing your natural circadian rhythm, and is most effective for jet lag, delayed sleep phase syndrome, and certain types of insomnia 1, 4. It's crucial to start with the lowest effective dose to minimize side effects like morning grogginess, headaches, or vivid dreams, and to consult a healthcare provider before using melatonin regularly for more than a few weeks, especially if you take other medications or have underlying health conditions.
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 Dosing
- The ideal dose of melatonin for sleep disorders is not clearly defined, with studies using a broad range of doses (0.1-2000 mg) 5.
- A systematic review and meta-analysis found that higher doses of melatonin (≥10 mg) appear to have a good safety profile, but may increase the risk of adverse events such as drowsiness, headache, and dizziness 6.
- The timing of melatonin treatment is also important, with evidence suggesting that it is most effective when taken at the right time to synchronize the circadian rhythms 7, 8.
- The suitable dose ranges and pharmaceutical preparations for melatonin administration are yet to be clearly defined, with more research needed to determine the optimal dosing regimen 9.
- Melatonin has been shown to be effective in improving sleep quality, duration, and onset, but the evidence is not yet conclusive, and more studies are needed to fully understand its effects 7, 5.