Melatonin oral solid dosage forms

What is this medicine?

MELATONIN (mel uh TOH nin) is a dietary supplement. It is mostly 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.

How should I use this medicine?

Take this supplement by mouth with a glass of water. Do not take with food. 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. Some products may be chewed or dissolved in the mouth before swallowing. Some tablets or capsules must be swallowed whole; do not cut, crush or chew. 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.

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

• confusion

• 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):

• dizziness

• drowsiness

• headache

• hot flashes

• nausea

• tiredness

• unusual dreams or nightmares

• upset stomach

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• fluvoxamine

• ramelteon

• tasimelteon

This medicine may also interact with the following medications:

• alcohol

• caffeine

• carbamazepine

• certain antibiotics like ciprofloxacin

• certain medicines for depression, anxiety, or psychotic disturbances

• cimetidine

• female hormones, like estrogens and birth control pills, patches, rings, or injections

• methoxsalen

• nifedipine

• other medications for sleep

• other herbal or dietary supplements

• phenobarbital

• rifampin

• smoking tobacco

• tamoxifen

• warfarin

What if I miss a dose?

If you miss taking your dose at the usual time, skip that dose. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature or as directed on the package label. Protect from moisture. Throw away any unused supplement after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cancer

• depression or mental illness

• diabetes

• 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

• breast-feeding

What should I watch for while using this medicine?

See your doctor if your symptoms do not get better or if they get worse. Do not take this supplement for more than 2 weeks unless your doctor tells you to.

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.

Talk to your doctor before you use this supplement if you are currently being treated for an emotional, mental, or sleep problem. This medicine may interfere with your treatment.

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.