From the Guidelines
The recommended starting dose of immediate-release melatonin for isolated RBD is 3 mg taken at bedtime, which can be titrated up to 15 mg in 3-mg increments to address dream enactment. According to the American Academy of Sleep Medicine clinical practice guideline 1, melatonin binds to the M1 and M2 receptors, suppressing REM sleep motor tone and renormalizing other circadian features of REM sleep. The dose may need to be adjusted based on the patient's response, but there is no evidence to support doses higher than 15 mg. It is 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 taking melatonin include:
- The dose may be increased in 3-mg increments to a maximum of 15 mg to address dream enactment
- Melatonin requires a prescription in the European Union and the United Kingdom
- Combination therapy using clonazepam and melatonin is common in clinical practice if response to monotherapy is inadequate, as reported in the Journal of Clinical Sleep Medicine 1
- Patients should be aware of the potential side effects of melatonin, although they are generally mild, and consult a healthcare provider if they have ongoing sleep problems.
It is crucial to prioritize the patient's safety and well-being when prescribing melatonin, considering their comorbidities and potential interactions with other medications, as emphasized in the guideline 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
- The ideal dose of melatonin is not explicitly stated in the provided studies, but one study 2 investigated the safety of higher doses of melatonin (≥10 mg) in adults.
- This study found that melatonin appeared to have a good safety profile, but the evidence was limited due to poor adverse event reporting in high-dose melatonin studies.
- The study 2 did find that higher doses of melatonin increased the risk of adverse events such as drowsiness, headache, and dizziness.
Alternative Treatments
- Other studies 3, 4, 5 focused on the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) and other interventions, such as light exposure, exercise, and complementary and alternative medicine.
- These studies found that CBT-I was an effective treatment for adults with chronic insomnia, and that melatonin was effective in improving sleep-onset difficulties.
- Study 6 found that controlled-release melatonin, singly and combined with cognitive behavioral therapy, was effective in treating persistent insomnia in children with autism spectrum disorders.
Considerations
- When considering melatonin dosage, it is essential to consult with a healthcare professional, as the optimal dose may vary depending on individual factors, such as age, medical conditions, and sleep disorders.
- More research is needed to determine the long-term safety and efficacy of high-dose melatonin, as well as the optimal dosage for different populations and sleep disorders 2.