Melatonin Capsules or Tablets

What is this medication?

MELATONIN (mel uh TOH nin) is promoted for sleep disorders, such as insomnia or jet lag. Melatonin helps regulate your sleep cycle. This supplement is not intended to diagnose, treat, cure, or prevent any disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Melatonex

What should I tell my care team before I take this medication?

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Do not take with food. This medication is usually taken 1 or 2 hours before bedtime. After taking this medication, 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 care team. Do not take this medication more often than directed.

Talk to your care team the use of this medication in children. Special care may be needed. This medication 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 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.

What may interact with this medication?

Do not take this medication with any of the following:

• Fluvoxamine
• Ramelteon
• Tasimelteon

This medication may also interact with the following:

• Alcohol
• Caffeine
• Carbamazepine
• Certain antibiotics like ciprofloxacin
• Certain medications for depression, anxiety, or psychotic disturbances
• Cimetidine
• Female hormones, like estrogens and birth control pills, patches, rings, or injections
• Methoxsalen
• Nifedipine
• Other herbal or dietary supplements
• Other medications for sleep
• Phenobarbital
• Rifampin
• Smoking tobacco
• Tamoxifen
• Warfarin

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 medication?

See your care team if your symptoms do not get better or if they get worse. Do not take this medication for more than 2 weeks unless your care team 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 medication 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 medication. Avoid alcoholic drinks.

After taking this medication, 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 care team right away if you find out you have done any of these activities. Do not take this medication if you have used alcohol that evening. Do not take it if you have taken another medication for sleep. The risk of doing these sleep-related activities is higher.

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

Herbal or dietary supplements are not regulated like medications. 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 medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bedwetting in children
• Dizziness
• Drowsiness the day after use
• Headache
• Nausea

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 medication?

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 medication 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.