From the Guidelines
The recommended dose of melatonin for isolated REM sleep behavior disorder is usually 3 mg taken at bedtime, which can be titrated up to 15 mg in 3-mg increments to address dream enactment. This recommendation is based on the most recent and highest quality study available, which was published in 2023 by the American Academy of Sleep Medicine 1. The study suggests that melatonin binds to the M1 and M2 receptors, suppressing REM sleep motor tone and renormalizing other circadian features of REM sleep.
Some key points to consider when prescribing melatonin include:
- The dose may need to be adjusted based on the patient's response to treatment and the presence of any side effects
- Melatonin is considered a dietary supplement and is available over the counter in the United States and Canada, but its bioavailability and content may vary across formulations
- Combination therapy using clonazepam and melatonin is common in clinical practice if response to monotherapy is inadequate, although there is limited data on the effectiveness of combination therapies 1
- Other studies have investigated the use of melatonin in different populations, such as children and adolescents, but the evidence is limited and the benefits and harms of treatment are uncertain 1
It's essential to note that the use of melatonin should be individualized and monitored by a healthcare provider, especially in patients with underlying medical conditions or those taking other medications. Additionally, patients should be informed about the potential side effects of melatonin, such as headache, dizziness, or daytime drowsiness, and the importance of purchasing melatonin from reputable sources.
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
Recommended Dose of Melatonin
The recommended dose of melatonin varies depending on the individual and the specific condition being treated.
- Studies have investigated the safety and efficacy of different melatonin doses, ranging from 0.3 mg to 10 mg 2, 3, 4, 5.
- A review of clinical studies found that doses of melatonin between 1 mg and 6 mg appear to be effective for improving sleep in older adults, but further studies are needed to determine the optimal minimum effective dose 5.
- Another study found that a high dose of 5 mg melatonin significantly increased sleep efficiency during both biological day and night in older adults 3.
- The optimal dosage of melatonin is unknown, and routinely used amounts vary substantially, with some studies suggesting that low to moderate dosages (approximately 5-6 mg daily or less) appear safe 4.
Safety and Efficacy
- 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 2.
- A narrative review found that melatonin's short-term negative effects are minimal, resolve at medicine cessation, and do not usually prevent usage overall, but long-term effects have been insufficiently studied and warrant additional investigation 4.
- A systematic review and network meta-analysis found that melatonin is effective in improving sleep-onset difficulties, but none of the considered interventions received superior evidence to Cognitive-Behavior Therapy for Insomnia (CBT-I) 6.