What are the guidelines for using melatonin (N-acetyl-5-methoxytryptamine) for sleep?

From the Guidelines

Melatonin should be used for sleep issues with caution, starting with the lowest effective dose of 0.5-1 mg, 30-60 minutes before bedtime, and gradually increasing if needed, as evidenced by the American Academy of Sleep Medicine clinical practice guideline 1. When considering melatonin for sleep, it's essential to weigh the benefits and potential harms. The American Academy of Sleep Medicine guideline suggests that the benefits of melatonin use appear to outweigh any potential harms, with no serious adverse reactions described to date 1.

Key Considerations

• Typical adult dosages range from 0.5-5 mg, with short-term use generally preferred, though some people with chronic insomnia or certain conditions may use it longer.
• Melatonin is most effective for circadian rhythm disorders like jet lag, shift work sleep disorder, or delayed sleep phase syndrome rather than general insomnia.
• Common side effects include headache, dizziness, nausea, and daytime drowsiness.
• Melatonin should be avoided by pregnant or breastfeeding women, those with autoimmune disorders, seizure disorders, or depression, and people taking certain medications including blood thinners, immunosuppressants, and some psychiatric medications.

Dosage and Administration

• The dosage of melatonin can change its effect, with 0.5 mg used to advance bedtime, and higher dosing (1-5 mg) given for a sedating effect 30 minutes before bed 1.
• Patient preference would be expected to favor the use of easily obtained and inexpensive melatonin that requires once daily dosing 1.

Combination with Sleep Hygiene Practices

• For best results, combine melatonin with good sleep hygiene practices like maintaining a regular sleep schedule, avoiding screens before bed, and creating a comfortable sleep environment.
• Melatonin works by supplementing the body's natural sleep hormone, which helps regulate the sleep-wake cycle by signaling to the brain when it's time to sleep.

From the FDA Drug Label

Helps establish normal sleep patterns nighttime sleep aid for occassional sleeplessness

The guidelines for using melatonin for sleep are to use it as a nighttime sleep aid for occasional sleeplessness to help establish normal sleep patterns 2.

• Dosage: The label mentions 3mg Tablets.
• Key characteristics: It is 100% drug-free and non-habit forming.

From the Research

Guidelines for Using Melatonin for Sleep

• Melatonin is a hormonal product of the pineal gland, and its primary role in humans is to maintain synchrony of sleep with the day/night cycle 3.
• When administered as a drug, melatonin affects a wide range of physiological systems and has clinically important drug interactions 3.
• The efficacy of melatonin for treating sleep disorders is modest and variable, but it can advance the time of sleep onset 3, 4.
• Melatonin appears to have the greatest impact on sleep onset in children with neurodevelopmental disabilities, but little effect on sleep efficiency 3.

Dosage and Administration

• The optimal dose of melatonin for promoting sleep is around 4 mg/day, and advancing the timing of administration to 3 hours before the desired bedtime may optimize its efficacy 5.
• The time of day and insomnia status are significant predictors of sleep onset latency, while the time of day is the only significant predictor of total sleep time 5.

Alternative Treatments

• Cognitive Behavioral Therapy for Insomnia (CBT-I) is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep, and is recommended as the first-line intervention for insomnia 6, 7.
• CBT-I has a large evidence base and has been shown to be effective in improving sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency 6.
• Other interventions, such as light exposure, exercise, and complementary and alternative medicine, may also be effective in improving sleep, but the evidence is less strong 4.