From the Guidelines
The recommended starting dose of immediate-release melatonin for isolated REM sleep behavior disorder is 3 mg taken at bedtime, which can be titrated up to 15 mg in 3-mg increments if needed. This dosage is based on the most recent clinical practice guideline from the American Academy of Sleep Medicine, published in the Journal of Clinical Sleep Medicine in 2023 1. The guideline suggests that melatonin can help suppress REM sleep motor tone and renormalize other circadian features of REM sleep, leading to improvements in symptoms. It's essential to note that melatonin is considered a dietary supplement in the United States and Canada, but its bioavailability and content may vary across formulations.
Some key points to consider when using melatonin for isolated REM sleep behavior disorder include:
- The dose may be increased up to 15 mg if the initial dose is not effective, but data on higher dosing is not available 1
- Melatonin requires a prescription in the European Union and the United Kingdom, but it is available over the counter in the United States and Canada 1
- Combination therapy using clonazepam and melatonin is common in clinical practice if response to monotherapy is inadequate, but there is limited data on the effectiveness of combination therapies 1
- Patients should be aware of potential side effects, such as headache, dizziness, and nausea, and consult a healthcare provider if they have any concerns or questions.
It's crucial to consult a healthcare provider before starting melatonin, especially for long-term use or if the patient has any underlying medical conditions or takes certain medications. The healthcare provider can help determine the best course of treatment and monitor the patient's response to melatonin.
From the FDA Drug Label
PRINCIPAL DISPLAY PANEL - Vitamin Bottle Label Safrel Melatonin 3mg Tablets: The recommended dose of melatonin is 3mg.
From the Research
Melatonin Dosage
The recommended dosage of melatonin varies depending on the individual and the specific condition being treated.
- Studies have investigated the safety and efficacy of different melatonin dosages, ranging from 0.1 mg to 50 mg 2.
- A systematic review of melatonin supplementation in older adults found that doses between 1 mg and 6 mg may be effective for improving sleep 3.
- Another study suggested that the lowest possible dose of immediate-release formulation melatonin should be used to mimic the normal physiological circadian rhythm of melatonin and avoid prolonged, supra-physiological blood levels 2.
- High-dose melatonin (≥10 mg) has been investigated in several studies, with some finding an increased risk of adverse events such as drowsiness, headache, and dizziness 4.
Factors Influencing Dosage
Several factors can influence the optimal dosage of melatonin, including:
- Age: Older adults may require lower doses of melatonin due to decreased melatonin levels and altered circadian rhythms 3, 2.
- Condition being treated: Different conditions, such as insomnia or jetlag, may require different melatonin dosages 5.
- Individual tolerance: People may have different sensitivities to melatonin, and some may experience adverse events at higher doses 4.
Safety and Efficacy
The safety and efficacy of melatonin have been investigated in several studies, with most finding that it is generally well-tolerated and effective for improving sleep 4, 3, 5.
- A systematic review and meta-analysis found that melatonin did not cause a detectable increase in serious adverse events or withdrawals due to adverse events, but did appear to increase the risk of adverse events such as drowsiness, headache, and dizziness 4.
- Another study found that melatonin was effective in improving sleep-onset difficulties and self-report sleep efficiency and severity of insomnia disorder 5.