What is melatonin?

The use of melatonin in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal/health supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Melatonin is also known as MEL. Melatonin is naturally produced in the body in response to the perception of light.

Melatonin has been used to ease insomnia, combat jet lag, protect cells from free-radical damage, boost the immune system, prevent cancer, and extend life.

Melatonin has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of melatonin may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Melatonin may also have uses other than those listed in this product guide.


Talk to your doctor before taking melatonin if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Melatonin may not be recommended in some situations.

Do not take melatonin without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether melatonin will harm an unborn baby.

Do not take melatonin without first talking to your doctor if you are breast-feeding a baby. It is also not known whether melatonin will harm a nursing infant.

There is no information available regarding the use of melatonin by children. Do not give any herbal/health supplement to a child without first talking to the child’s doctor.

There are no known restrictions on food, beverages, or activity while taking melatonin, unless otherwise directed by your health care provider.

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Seek emergency medical attention.

Symptoms of a melatonin overdose may include headache, drowsiness, and upset stomach.

No information is available regarding a missed dose of melatonin. Consult your doctor, pharmacist, or health care provider if you require further information.

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Side effects

Although uncommon, allergic reactions to melatonin have been reported. Stop taking melatonin and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Other less serious side effects have also been reported. Talk to your doctor or pharmacist if you experience

  • headache;
  • drowsiness; or
  • stomach upset.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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No drugs have been reported to interact with melatonin. Talk to your doctor, pharmacist, or health care provider before taking any prescription or over-the-counter medicines or other herbal/health supplements.

Other Names

Bio-Melatonin, Health Aid Melatonin, Melatonin, Melatonin Time Release, S.Gard, VesPro Melatonin, and melatonin

Available Strengths & Dosages

Route Form Strength
oral tablet, extended release 3 mg

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Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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