From the Guidelines
A 60mg dose of melatonin is excessive and potentially harmful, with the recommended dosage for isolated RBD typically starting at 3 mg taken at bedtime and titrated up to 15 mg as needed 1. The use of high-dose melatonin may lead to increased risk of side effects, including severe drowsiness, headaches, dizziness, nausea, irritability, and disruption of the natural sleep-wake cycle. Key considerations for melatonin dosing include:
- Starting with a low dose, such as 3 mg, to minimize side effects and assess efficacy
- Gradually increasing the dose in 3-mg increments as needed and tolerated, up to a maximum of 15 mg
- Being aware of potential interactions with other medications, including blood thinners, anticonvulsants, immunosuppressants, and diabetes medications
- Monitoring for severe symptoms and seeking medical attention if concerned, especially in cases of high-dose ingestion It is essential to follow established guidelines and consult with a healthcare professional to determine the appropriate melatonin dosage for individual patients, as excessive doses may not provide proportional benefits and may increase the risk of adverse effects 1.
From the Research
Melatonin Toxicity Potential
- The provided studies do not specifically address the toxicity potential of 60mg melatonin 2, 3, 4, 5, 6.
- However, the studies suggest that melatonin is generally considered safe and well-tolerated, even at high doses 3, 4.
- A study found that daily melatonin doses ranged from 0.15mg to 12mg, and most adverse events were mild to moderate, with no life-threatening or major clinical significance reported 3.
- Another study reported that the mean maximal tolerated dose of melatonin was 11.9mg/day, with infrequent and not statistically different adverse events compared to placebo 5.
- It is essential to note that the safety of prolonged use of melatonin is not well-established, and there may be factors that increase the risk of adverse effects in certain populations, such as older adults 4.
Adverse Events Associated with Melatonin
- The most frequently reported adverse events associated with melatonin include daytime sleepiness, headache, other sleep-related adverse events, dizziness, and hypothermia 3.
- Serious or clinically significant adverse events, such as agitation, fatigue, mood swings, nightmares, skin irritation, and palpitations, were rare and usually resolved spontaneously or upon withdrawal of treatment 3.
Melatonin Dosage and Efficacy
- The efficacy of melatonin for sleep disorders is modest and variable, with the ability to advance the time of sleep onset but little effect on sleep efficiency 6.
- A study found that 5mg melatonin significantly increased sleep efficiency during both biological day and night, mainly by increasing the duration of Stage 2 non-rapid eye movement sleep and slightly shortening awakenings 2.