Title
Subscribe to the Magazine for free
Subscribe for free to keep reading! If you are already subscribed, enter your email address to log back in.
Thanks for subscribing!
Oops! Something went wrong while submitting the form.
Are you a healthcare practitioner?
Thanks for subscribing!
Oops! Something went wrong while submitting the form.

Unlocking the Mysteries of Melatonin: Exploring Safety and Efficacy

Why This Was Updated?

Our specialists regularly review advancements in health and wellness, ensuring our articles are updated with the newest information as it becomes accessible.
Medically Reviewed by
Updated On
October 4, 2024

More and more people are turning to melatonin supplements, which are widely used to promote sleep and circadian rhythm regulation. 

Many people turn to melatonin to address sleep disorders such as:

This article describes the hormone melatonin, its indications for use, recommended dosage, safety, and side effects. It also describes normal natural melatonin levels and functional medicine labs that measure melatonin levels. 

[signup]

What is Melatonin?

Melatonin (N-acetyl-5-methoxytryptamine) is a hormone produced by the pineal gland, which is located in the brain and is part of the endocrine system.  

  • Melatonin is produced in response to darkness and helps regulate the sleep-wake cycle and circadian rhythms. This process is initiated by photic (light)  input to the suprachiasmatic nucleus (SCN) in the brain, which serves as the primary circadian pacemaker. 
  • The pineal gland receives information about the sleep-wake cycle (day-night cycle) from the eyes' retinas. When it senses that it is dark outside, then melatonin production increases. It continues to be secreted throughout the night to help people achieve continued sleep. 
  • Melatonin is inversely related to the hormone cortisol. When a person is exposed to light, the SCN triggers the activation of the Hypothalamic Pituitary Adrenal (HPA) axis. This leads to the synthesis and release of cortisol, a glucocorticoid hormone that peaks in the morning upon waking. This is known as the Cortisol Awakening Response (CAR). As cortisol levels decrease as the day goes on, then melatonin increases. 

Melatonin is produced every night in humans. Light exposure in the evening can hinder melatonin production for the first part of the night and delay melatonin production the following night. Melatonin secretion is also determined by the day length, meaning that in short days of the winter, melatonin secretion is longer and shorter during the longer days of summer.  

Supplemental Melatonin Dosing 

Melatonin has been sold as a dietary supplement in the United States since 1994 and marketed as a cure for insomnia. Supplements are not regulated by the Food and Drug Administration (FDA), so the dose of the supplements cannot be verified. This means that the actual dose of melatonin could be more or less than what is advertised. 

Melatonin supplements come in doses of 1 mg to 10 mg. It is recommended to start with 1 mg and increase the dose by 1 mg weekly until a dose helps the person fall asleep faster. It is important to take melatonin supplements at the correct time to ensure they are most effective. 

The best time to take melatonin is when the person is feeling tired, prior to bedtime.  It is very easy to overcome the effects of melatonin. If a person starts watching television, playing video games, or using their phone and is exposed to light, the supplement may not work. That is why the timing of administration is important. 

Dosing of melatonin is dependent on age. Dosing recommendations for children are:

  • Ages 3 to 5: 1 to 3 mg
  • Ages 5 to 10: 2 to 5 mg
  • Adolescents: 5 to 10 mg

The maximum dose that should be given to children is 12 mg. The dose should start low and gradually increase. It is recommended that children only use melatonin for 2 to 3 weeks, but there are some exceptions. Children who have attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) may need long-term supplementation with melatonin. 

Some children should not be given melatonin. This includes children under 2 years of age because the brain is still maturing, children who have migraines with auras, and children with immune disorders because of melatonin’s immunomodulating properties. 

What Are Normal Melatonin Levels? 

Melatonin levels vary based on a person’s gender and age.

  • Newborn babies do not produce a substantial amount of melatonin. They receive it from the placenta in utero and through breast milk after birth. Regular melatonin production starts occurring at 2 to 3 months of age. 
  • Melatonin levels increase in childhood and peak at puberty. 
  • In all ages after puberty, melatonin levels are higher in women than men.
  • Melatonin levels gradually decline after the age of 40. 

Side Effects 

If a person takes too much melatonin or takes it late in the day, then it can cause drowsiness, sluggishness, or decreased reaction time the next day. Some common side effects of melatonin include:

Mild side effects in children include headache, dizziness, nausea, and sleepiness. 

Functional Medicine Labs That Test Melatonin Levels 

To determine if a patient would benefit from melatonin supplementation, practitioners may choose to assess melatonin levels using various methods. 

Testing via saliva and urine is the most common way to determine melatonin levels. Serum blood levels are not commonly used because they vary greatly over a 24-hour period. 

One common saliva test used is called the Melatonin Profile. This test involves collecting saliva at different times throughout the day. The report gives a reading of levels in the morning, evening, and night to determine if melatonin is produced at the appropriate levels and at the appropriate times. 

The DUTCH (Dried Urine Test for Comprehensive Hormones) Plus test uses urine samples collected over a 24-hour period to assess hormone levels and their metabolites. This includes estrogen, progesterone, and androgens and their metabolites, as well as extra markers like melatonin, which is measured as 6-OH-Melatonin-Sulfate.  

Alternatives to Melatonin 

There are other supplements that have been shown to improve sleep, but most of them, like melatonin, are only meant to be used short-term. Some of these include:

Lifestyle modifications should also be used in conjunction with any sleep supplementation. These include getting to the root cause of the sleep issue and adjusting as needed. This can include changes to sleep hygiene habits and changes in diet. 

Is Melatonin Safe?

Melatonin appears safe for short-term use, but there is insufficient information to determine long-term safety and effects. Some of the concerns regarding melatonin include:

Interactions with Medications

  • People with epilepsy and who are taking blood thinners should be under medical supervision when taking melatonin supplements. 
  • Some medicines may increase the effects of melatonin. Examples include enasidenib, used for treating leukemia, mexiletine, for the treatment of heart arrhythmias, and fluvoxamine, used for treatingf depression, increase the level of the hepatic enzyme CYP1A2.

Regulated as a Dietary Supplement 

  • The FDA less strictly regulates dietary supplements than prescription medications. In some countries, melatonin is available only with a prescription. 

Safety Concerns for Older People

Safety Concerns for Children

[signup]

Key Takeaways

  • Melatonin supplementation, when used short-term in children and adults, is safe. 
  • More long-term studies are needed to show the safety of melatonin use beyond 2-3 weeks. 
  • If melatonin is needed for longer than 3 weeks, a thorough workup should be done that includes a dietary and lifestyle assessment and lab testing to determine any underlying cause of insomnia.

More and more people are turning to melatonin supplements, which are widely used to support sleep and circadian rhythm regulation. 

Many people consider melatonin to help manage sleep disturbances such as:

This article describes the hormone melatonin, its potential uses, general dosage guidelines, safety, and possible side effects. It also describes normal natural melatonin levels and functional medicine labs that measure melatonin levels. 

[signup]

What is Melatonin?

Melatonin (N-acetyl-5-methoxytryptamine) is a hormone produced by the pineal gland, which is located in the brain and is part of the endocrine system.  

  • Melatonin is produced in response to darkness and helps regulate the sleep-wake cycle and circadian rhythms. This process is initiated by photic (light)  input to the suprachiasmatic nucleus (SCN) in the brain, which serves as the primary circadian pacemaker. 
  • The pineal gland receives information about the sleep-wake cycle (day-night cycle) from the eyes' retinas. When it senses that it is dark outside, then melatonin production increases. It continues to be secreted throughout the night to help people achieve continued sleep. 
  • Melatonin is inversely related to the hormone cortisol. When a person is exposed to light, the SCN triggers the activation of the Hypothalamic Pituitary Adrenal (HPA) axis. This leads to the synthesis and release of cortisol, a glucocorticoid hormone that peaks in the morning upon waking. This is known as the Cortisol Awakening Response (CAR). As cortisol levels decrease as the day goes on, then melatonin increases. 

Melatonin is produced every night in humans. Light exposure in the evening can hinder melatonin production for the first part of the night and delay melatonin production the following night. Melatonin secretion is also determined by the day length, meaning that in short days of the winter, melatonin secretion is longer and shorter during the longer days of summer.  

Supplemental Melatonin Dosing 

Melatonin has been sold as a dietary supplement in the United States since 1994. Supplements are not regulated by the Food and Drug Administration (FDA), so the dose of the supplements cannot be verified. This means that the actual dose of melatonin could be more or less than what is advertised. 

Melatonin supplements come in doses of 1 mg to 10 mg. It is often suggested to start with 1 mg and increase the dose by 1 mg weekly until a dose helps the person fall asleep faster. It is important to take melatonin supplements at the correct time to ensure they are most effective. 

The best time to take melatonin is when the person is feeling tired, prior to bedtime.  It is very easy to overcome the effects of melatonin. If a person starts watching television, playing video games, or using their phone and is exposed to light, the supplement may not work. That is why the timing of administration is important. 

Dosing of melatonin is dependent on age. Dosing suggestions for children are:

  • Ages 3 to 5: 1 to 3 mg
  • Ages 5 to 10: 2 to 5 mg
  • Adolescents: 5 to 10 mg

The maximum dose that should be given to children is 12 mg. The dose should start low and gradually increase. It is often suggested that children only use melatonin for 2 to 3 weeks, but there are some exceptions. Children who have attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) may need long-term supplementation with melatonin. 

Some children should not be given melatonin. This includes children under 2 years of age because the brain is still maturing, children who have migraines with auras, and children with immune disorders because of melatonin’s immunomodulating properties. 

What Are Normal Melatonin Levels? 

Melatonin levels vary based on a person’s gender and age.

  • Newborn babies do not produce a substantial amount of melatonin. They receive it from the placenta in utero and through breast milk after birth. Regular melatonin production starts occurring at 2 to 3 months of age. 
  • Melatonin levels increase in childhood and peak at puberty. 
  • In all ages after puberty, melatonin levels are higher in women than men.
  • Melatonin levels gradually decline after the age of 40. 

Side Effects 

If a person takes too much melatonin or takes it late in the day, then it can cause drowsiness, sluggishness, or decreased reaction time the next day. Some common side effects of melatonin include:

Mild side effects in children include headache, dizziness, nausea, and sleepiness. 

Functional Medicine Labs That Test Melatonin Levels 

To determine if a patient might benefit from melatonin supplementation, practitioners may choose to assess melatonin levels using various methods. 

Testing via saliva and urine is the most common way to determine melatonin levels. Serum blood levels are not commonly used because they vary greatly over a 24-hour period. 

One common saliva test used is called the Melatonin Profile. This test involves collecting saliva at different times throughout the day. The report gives a reading of levels in the morning, evening, and night to determine if melatonin is produced at the appropriate levels and at the appropriate times. 

The DUTCH (Dried Urine Test for Comprehensive Hormones) Plus test uses urine samples collected over a 24-hour period to assess hormone levels and their metabolites. This includes estrogen, progesterone, and androgens and their metabolites, as well as extra markers like melatonin, which is measured as 6-OH-Melatonin-Sulfate.  

Alternatives to Melatonin 

There are other supplements that have been shown to support sleep, but most of them, like melatonin, are only meant to be used short-term. Some of these include:

Lifestyle modifications should also be considered in conjunction with any sleep supplementation. These include getting to the root cause of the sleep issue and adjusting as needed. This can include changes to sleep hygiene habits and changes in diet. 

Is Melatonin Safe?

Melatonin appears safe for short-term use, but there is insufficient information to determine long-term safety and effects. Some of the concerns regarding melatonin include:

Interactions with Medications

  • People with epilepsy and who are taking blood thinners should be under medical supervision when taking melatonin supplements. 
  • Some medicines may increase the effects of melatonin. Examples include enasidenib, used for managing leukemia, mexiletine, for the management of heart arrhythmias, and fluvoxamine, used for managing depression, increase the level of the hepatic enzyme CYP1A2.

Regulated as a Dietary Supplement 

  • The FDA less strictly regulates dietary supplements than prescription medications. In some countries, melatonin is available only with a prescription. 

Safety Concerns for Older People

Safety Concerns for Children

[signup]

Key Takeaways

  • Melatonin supplementation, when used short-term in children and adults, is generally considered safe. 
  • More long-term studies are needed to show the safety of melatonin use beyond 2-3 weeks. 
  • If melatonin is needed for longer than 3 weeks, a thorough workup should be done that includes a dietary and lifestyle assessment and lab testing to determine any underlying cause of insomnia.
The information provided is not intended to be a substitute for professional medical advice. Always consult with your doctor or other qualified healthcare provider before taking any dietary supplement or making any changes to your diet or exercise routine.
Learn More
No items found.

Lab Tests in This Article

  1. American Psychiatric Association. (2024.) What is ADHD? https://www.psychiatry.org/patients-families/adhd/what-is-adhd
  2. American Psychiatric Association. (2024). What is autism spectrum disorder? https://www.psychiatry.org/patients-families/autism/what-is-autism-spectrum-disorder
  3. Bauer, B. (2017). Is melatonin a helpful sleep aid — and what should I know about melatonin side effects? Mayo Clinic. https://www.mayoclinic.org/healthy-lifestyle/adult-health/expert-answers/melatonin-side-effects/faq-20057874
  4. Bertagna, B. (2024). Melatonin for sleep: Unlocking the power of this hormone for restful nights. Rupa Health Magazine. https://www.rupahealth.com/post/melatonin-for-sleep-unlocking-the-power-of-this-hormone-for-restful-nights
  5. Bryan, L. and Guo, L. (2024). Circadian rhythm: What it is, what shapes it, and why it’s fundamental to getting quality sleep. https://www.sleepfoundation.org/circadian-rhythm
  6. Bryan, L. and Cotliar, D. (2024). Natural sleep aids: Which are the most effective? https://www.sleepfoundation.org/sleep-aids/natural-sleep-aids
  7. Bryant, A. 2024. The top 5 supplements to help you sleep. Rupa Health Magazine. https://www.rupahealth.com/post/the-top-5-supplements-to-help-you-sleep
  8. Children’s Healthcare of Atlanta. (2021). Do’s and don’ts of giving melatonin to kids. https://www.choa.org/parent-resources/caring-for-your-kid-at-home/melatonin-and-safe-sleep
  9. Children’s Healthcare of Atlanta. (2024). Immune systems 101: What they are and what immune disorders mean. https://www.choa.org/parent-resources/immune-systems/immune-system-disorders-in-kids
  10. Christie, J. (2023). Why you should incorporate melatonin testing into your practice? Rupa Health Magazine. https://www.rupahealth.com/post/testing-melatonin-levels-101
  11. Cleveland Clinic. (2022). Melatonin: How much should you take? https://health.clevelandclinic.org/melatonin-how-much-should-i-take-for-a-good-nights-rest
  12. Cleveland Clinic. (2022). Melatonin. https://my.clevelandclinic.org/health/articles/23411-melatonin
  13. Cloyd, J. (2023). A root cause medicine protocol for patients with insomnia: Testing, Therapeutic Diet, and Supportive Supplements. Rupa Health Magazine.https://www.rupahealth.com/post/a-root-cause-medicine-protocol-for-patients-with-insomnia-testing-therapeutic-diet-and-supportive-supplements?utm_source=google&utm_medium=cpc&utm_campaign=20893116874&utm_content=&utm_term=&gad_source=1
  14. Cloyd, J. (2024). Guide to androgens: Definition, functions, and more. Rupa Health Magazine. https://www.rupahealth.com/post/androgen-hormones
  15. Cloyd, J. (2023). The top 6 essential health benefits of magnesium that you should know. Rupa Health Magazine. https://www.rupahealth.com/post/the-top-6-therapeutic-uses-of-magnesium-you-need-to-know
  16. Dogra R, Bhatia R, Shankar R, Bansal P, Rawal RK. Enasidenib: First Mutant IDH2 Inhibitor for the Treatment of Refractory and Relapsed Acute Myeloid Leukemia. Anticancer Agents Med Chem. 2018;18(14):1936-1951. doi: 10.2174/1871520618666181025091128. PMID: 30360730.
  1. Janjua I, Goldman RD. Sleep-related melatonin use in healthy children. Can Fam Physician. 2016 Apr;62(4):315-7. PMID: 27076541; PMCID: PMC4830653.
  2. Kalaichandran, A. (2024). The Clockwork mood: Understanding our internal rhythms. Rupa Health Magazine. https://www.rupahealth.com/post/the-clockwork-mood-understanding-our-internal-rhythms
  1. Kawai, N., Sakai, N., Okuro, M., Karakawa, S., Tsuneyoshi, Y., Kawasaki, N., Takeda, T., Bannai, M., & Nishino, S. (2015). The Sleep-Promoting and Hypothermic Effects of Glycine are Mediated by NMDA Receptors in the Suprachiasmatic Nucleus. Neuropsychopharmacology, 40(6), 1405–1416. https://doi.org/10.1038/npp.2014.326
  2. Kennaway, D. J. (2022). What do we really know about the safety and efficacy of melatonin for sleep disorders? Current Medical Research and Opinion, 38(2), 211–227. https://doi.org/10.1080/03007995.2021.2000714
  3. Kresge, K. (2023). An integrative medicine team approach to treating anxiety. Rupa Health Magazine. https://www.rupahealth.com/post/an-integrative-medicine-team-approach-to-treating-anxiety
  4. Kresge, K. (2023). An integrative medicine approach to depression. Rupa Health Magazine. https://www.rupahealth.com/post/an-integrative-medicine-approach-to-depression
  5. LoBisco, S. (2022). Progesterone imbalance: Signs & treatments. Rupa Health Magazine. https://www.rupahealth.com/post/progesterone-imbalance-signs-treatments
  6. Mayo Clinic. (n.d.). Delayed sleep phase - Symptoms and causes. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/delayed-sleep-phase/symptoms-causes/syc-20353340
  7. Medscape. (2024). Luvox (fluvoxamine). https://reference.medscape.com/drug/luvox-fluvoxamine-342956
  8. Medscape. (2024). Melatonin (Herb/Suppl). https://reference.medscape.com/drug/n-acetyl-5-methoxytryptamine-pineal-hormone-melatonin-melatonin-344545#0
  9. Medscape. (2024). Mexiletine (Rx). https://reference.medscape.com/drug/mexiletine-342303
  10. Melinda, A. and Morrison, E. H. 2023. Neuroanatomy, nucleus suprachiasmatic. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK546664/
  11. National Center for Complementary and Integrative Health. (2024). Melatonin: What you need to know. https://www.nccih.nih.gov/health/melatonin-what-you-need-to-know
  12. National Institutes of Health. (2013). Valerian. https://ods.od.nih.gov/factsheets/Valerian-HealthProfessional/
  13. Smith SM, Vale WW. The role of the hypothalamic-pituitary-adrenal axis in neuroendocrine responses to stress. Dialogues Clin Neurosci. 2006;8(4):383-95. doi: 10.31887/DCNS.2006.8.4/ssmith. PMID: 17290797; PMCID: PMC3181830.
  14. Sweetnich, J. (2023). Integrative medicine treatments for migraine sufferers. Rupa Health Magazine. https://www.rupahealth.com/post/integrative-medicine-treatments-for-migraines
  15. Sweetnich, J. (2023). Top evidence-based supplements and herbs for restful nights, backed by specialty lab testing to personalize treatment. Rupa Health Magazine. https://www.rupahealth.com/post/top-evidence-based-supplements-and-herbs-that-help-with-sleep-plus-specialty-lab-testing-that-can-help-identify-which-one-is-best-for-your-patients
  16. Thorn CF, Aklillu E, Klein TE, Altman RB. PharmGKB summary: very important pharmacogene information for CYP1A2. Pharmacogenet Genomics. 2012 Jan;22(1):73-7. doi: 10.1097/FPC.0b013e32834c6efd. Erratum in: Pharmacogenet Genomics. 2019 Nov;29(9):224. PMID: 21989077; PMCID: PMC3346273.
  17. Weinberg, J. (2022). How to tell if you have an estrogen imbalance. Rupa Health Magazine. https://www.rupahealth.com/post/a-functional-medicine-approach-to-estrogen-imbalance
  18. Weinberg, J. (2023). The science of sleep: Functional medicine for restorative sleep. Rupa Health Magazine. https://www.rupahealth.com/post/the-science-of-sleep-functional-medicine-for-restorative-sleep
Subscribe to the Magazine for free to keep reading!
Subscribe for free to keep reading, If you are already subscribed, enter your email address to log back in.
Thanks for subscribing!
Oops! Something went wrong while submitting the form.
Are you a healthcare practitioner?
Thanks for subscribing!
Oops! Something went wrong while submitting the form.
See All Magazine Articles
Trusted Source
Rupa Health
Medical Education Platform
Visit Source
American Cancer Society
Foundation for Cancer Research
Visit Source
National Library of Medicine
Government Authority
Visit Source
Journal of The American College of Radiology
Peer Reviewed Journal
Visit Source
National Cancer Institute
Government Authority
Visit Source
World Health Organization (WHO)
Government Authority
Visit Source
The Journal of Pediatrics
Peer Reviewed Journal
Visit Source
CDC
Government Authority
Visit Source
Office of Dietary Supplements
Government Authority
Visit Source
National Heart Lung and Blood Institute
Government Authority
Visit Source
National Institutes of Health
Government Authority
Visit Source
Clinical Infectious Diseases
Peer Reviewed Journal
Visit Source
Brain
Peer Reviewed Journal
Visit Source
The Journal of Rheumatology
Peer Reviewed Journal
Visit Source
Journal of the National Cancer Institute (JNCI)
Peer Reviewed Journal
Visit Source
Journal of Cardiovascular Magnetic Resonance
Peer Reviewed Journal
Visit Source
Hepatology
Peer Reviewed Journal
Visit Source
The American Journal of Clinical Nutrition
Peer Reviewed Journal
Visit Source
The Journal of Bone and Joint Surgery
Peer Reviewed Journal
Visit Source
Kidney International
Peer Reviewed Journal
Visit Source
The Journal of Allergy and Clinical Immunology
Peer Reviewed Journal
Visit Source
Annals of Surgery
Peer Reviewed Journal
Visit Source
The Journal of Neurology, Neurosurgery & Psychiatry
Peer Reviewed Journal
Visit Source
Chest
Peer Reviewed Journal
Visit Source
Blood
Peer Reviewed Journal
Visit Source
Gastroenterology
Peer Reviewed Journal
Visit Source
The American Journal of Respiratory and Critical Care Medicine
Peer Reviewed Journal
Visit Source
The American Journal of Psychiatry
Peer Reviewed Journal
Visit Source
Diabetes Care
Peer Reviewed Journal
Visit Source
The Journal of the American College of Cardiology (JACC)
Peer Reviewed Journal
Visit Source
The Journal of Clinical Oncology (JCO)
Peer Reviewed Journal
Visit Source
Journal of Clinical Investigation (JCI)
Peer Reviewed Journal
Visit Source
Circulation
Peer Reviewed Journal
Visit Source
JAMA Internal Medicine
Peer Reviewed Journal
Visit Source
PLOS Medicine
Peer Reviewed Journal
Visit Source
Annals of Internal Medicine
Peer Reviewed Journal
Visit Source
Nature Medicine
Peer Reviewed Journal
Visit Source
The BMJ (British Medical Journal)
Peer Reviewed Journal
Visit Source
The Lancet
Peer Reviewed Journal
Visit Source
Journal of the American Medical Association (JAMA)
Peer Reviewed Journal
Visit Source
Pubmed
Comprehensive biomedical database
Visit Source
Harvard
Educational/Medical Institution
Visit Source
Cleveland Clinic
Educational/Medical Institution
Visit Source
Mayo Clinic
Educational/Medical Institution
Visit Source
The New England Journal of Medicine (NEJM)
Peer Reviewed Journal
Visit Source
Johns Hopkins
Educational/Medical Institution
Visit Source