MELATONIN (mel uh TOH nin) is a dietary supplement. It is promoted to help maintain normal sleep patterns. The FDA has not approved this supplement for any medical use.
This supplement may be used for other purposes; ask your health care provider or pharmacist if you have questions.
Take this supplement by mouth with a glass of water. Do not take with food. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. This supplement is usually taken 1 or 2 hours before bedtime. After taking this supplement, limit your activities to those needed to prepare for bed. Follow the directions on the package labeling, or take as directed by your health care professional. Do not take this supplement more often than directed.
Talk to your pediatrician regarding the use of this supplement in children. Special care may be needed. This supplement is not recommended for use in children without a prescription.
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
depressed mood, irritable, or other changes in moods or behaviors
feeling faint or lightheaded, falls
increased blood pressure
irregular or missed menstrual periods
signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
trouble staying awake or alert during the day
unusual activities while you are still asleep like driving, eating, making phone calls
unusual bleeding or bruising
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
unusual dreams or nightmares
Do not take this medicine with any of the following medications:
This medicine may also interact with the following medications:
certain antibiotics like ciprofloxacin
certain medicines for depression, anxiety, or psychotic disturbances
female hormones, like estrogens and birth control pills, patches, rings, or injections
other medications for sleep
other herbal or dietary supplements
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Keep out of the reach of children.
Store as directed on the package label. Throw away any unused supplement after the expiration date.
They need to know if you have any of these conditions:
depression or mental illness
if you often drink alcohol
immune system problems
lung or breathing disease, like asthma
an unusual or allergic reaction to melatonin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
If you are already being treated for insomnia use this supplement only by your doctor's direction. This supplement may interfere with other treatments. See your doctor if your symptoms do not get better or if they get worse.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
Herbal or dietary supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.
The Food and Drug Administration suggests the following to help consumers protect themselves:
Always read product labels and follow directions.
Natural does not mean a product is safe for humans to take.
Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.
Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.