What is the safety of melatonin (N-acetyl-5-methoxytryptamine) supplements for insomnia?

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Last updated: May 18, 2025View editorial policy

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From the Guidelines

Melatonin supplements are generally considered safe for short-term use to help with sleep problems, with a typical dose ranging from 1-5 mg taken 30-60 minutes before bedtime, as evidenced by a study published in the Journal of Clinical Sleep Medicine in 2017 1. For adults, it's best to start with the lowest effective dose (0.5-1 mg) to minimize potential side effects. Melatonin is a hormone naturally produced by your pineal gland that helps regulate your sleep-wake cycle, and supplements can be helpful for jet lag, shift work sleep disorder, or occasional insomnia. Some key points to consider when using melatonin supplements include:

  • Side effects are usually mild and may include headache, dizziness, nausea, or daytime drowsiness, as reported in a study published in the Annals of Internal Medicine in 2016 1.
  • Melatonin is not recommended for pregnant or breastfeeding women, and those with autoimmune disorders, seizure disorders, or depression should consult a doctor first, as advised in a clinical practice guideline from the American College of Physicians in 2016 1.
  • It may interact with certain medications including blood thinners, immunosuppressants, and some diabetes medications.
  • While melatonin is available over-the-counter in many countries, it's best used for short periods rather than as a long-term solution for chronic sleep problems, as recommended in a study published in the Journal of Clinical Sleep Medicine in 2017 1. If sleep issues persist beyond a few weeks, consult a healthcare provider to address underlying causes. Additionally, cognitive behavioral therapy for insomnia (CBT-I) and other non-pharmacological interventions, such as stimulus control and relaxation strategies, may be effective in managing chronic insomnia disorder, as suggested in a clinical practice guideline from the American College of Physicians in 2016 1.

From the Research

Safety of Melatonin Pills for Sleep

  • Melatonin is considered to be well-tolerated and has no obvious short- or long-term adverse effects 2
  • It has been shown to synchronize the circadian rhythms, and improve the onset, duration, and quality of sleep 2
  • Melatonin slightly improves sleep onset and sleep duration, but product quality and efficacy may vary 3
  • Valerian and melatonin are unregulated products that have a small impact on sleep latency and can produce residual sedation 4

Comparison with Other Sleep Medications

  • Benzodiazepines are discouraged in the geriatric population, especially for long-term use, due to the risk of dependence and addiction 3, 4
  • Non-benzodiazepine receptor agonists have improved safety profiles compared with benzodiazepines, but their side effects include dementia, serious injury, and fractures 4
  • Ramelteon has a minimal adverse effect profile and is effective for sleep-onset latency and increased total sleep time, making it a valuable first-line option 4
  • Melatonin offers an alternative treatment to the currently available pharmaceutical therapies for sleep disorders with significantly less side effects 2

Recommendations for Use

  • Cognitive behavioral therapy should always be the first-line treatment for insomnia 4, 5
  • Melatonin may be considered as a treatment option for insomnia, especially in patients who are unable to pursue cognitive behavioral therapies or have comorbid mental disorders 3, 2, 4
  • The choice of a hypnotic agent, including melatonin, should be symptom-based and take into account the patient's individual needs and medical history 3

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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