What is this medicine?
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.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
- depression or mental illness
- hormone problems
- if you often drink alcohol
- immune system problems
- liver disease
- lung or breathing disease, like asthma
- organ transplant
- seizure disorder
- an unusual or allergic reaction to melatonin, other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
How should I use this medicine?
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.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
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.
What may interact with this medicine?
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
- smoking tobacco
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
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.
After taking this medicine, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening. Do not take it if you have taken another medicine for sleep. The risk of doing these sleep-related activities is higher.
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.
What side effects may I notice from receiving this medicine?
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
- breathing problems
- 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):
- hot flashes
- unusual dreams or nightmares
- upset stomach
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store as directed on the package label. Throw away any unused supplement after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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