melatonin (Advanced Sleep Melatonin)

Brand Names: Advanced Sleep Melatonin, Dual Spectrum Melatonin, Melatonin, Melatonin Time Release, Nature's Bounty Dual Spectrum Melatonin

Generic Name: melatonin

• What is melatonin?
• What are the possible side effects of melatonin?
• What is the most important information I should know about melatonin?
• What should I discuss with my health care provider before taking melatonin?
• How should I take melatonin?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking melatonin?
• What other drugs will affect melatonin?
• Where can I get more information?

Melatonin is a manmade form of a hormone produced in the brain that helps regulate your sleep and wake cycle.

Melatonin has been used in alternative medicine as a likely effective aid in treating insomnia (trouble falling asleep or staying asleep). Melatonin is also likely effective in treating sleep disorders in people who are blind.

Melatonin is also possibly effective in treating jet lag, high blood pressure, tumors, low blood platelets (blood cells that help your blood to clot), insomnia caused by withdrawal from drug addiction, or anxiety caused by surgery. A topical form of melatonin applied to the skin is possibly effective in preventing sunburn.

Melatonin has also been used to treat infertility, to improve sleep problems caused by shift work, or to enhance athletic performance. However, research has shown that melatonin may not be effective in treating these conditions.

Other uses not proven with research have included treating depression, bipolar disorder, dementia, macular degeneration, attention deficit hyperactivity disorder, enlarged prostate, chronic fatigue syndrome, fibromyalgia, restless leg syndrome, stomach ulcers, irritable bowel syndrome, nicotine withdrawal, and many other conditions.

It is not certain whether melatonin is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Melatonin should not be used in place of medication prescribed for you by your doctor.

Melatonin is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be 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 be used for purposes not listed in this product guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although not all side effects are known, melatonin is thought to be possibly safe when taken for a short period of time (up to 2 years in some people).

Common side effects may include:

• daytime drowsiness;
• depressed mood, feeling irritable;
• stomach pain;
• headache; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use melatonin if you are allergic to it.

Before using melatonin, talk to your healthcare provider. You may not be able to use melatonin if you have certain medical conditions, especially:

• diabetes;
• depression;
• a bleeding or blood clotting disorder such as hemophilia;
• high or low blood pressure;
• epilepsy or other seizure disorder; or
• if you are using any medicine to prevent organ transplant rejection.

Ask a doctor before using this product if you are pregnant or breastfeeding.

High doses of melatonin may affect ovulation, making it difficult for you to get pregnant.

Do not give any herbal/health supplement to a child without medical advice.

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use melatonin, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Use the lowest dose of melatonin when you first start taking this product.

Take melatonin at bedtime, or when you are getting ready for sleep. If you use this product to treat jet lag, take the melatonin at bedtime on the day you arrive at your destination and keep using this product for 2 to 5 days.

If you take this product to treat other conditions not related to sleep, follow your healthcare provider's instructions about when and how to take melatonin.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Do not swallow the orally disintegrating tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if the condition you are treating with melatonin does not improve, or if it gets worse while using this product.

Store at room temperature away from moisture and heat.

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow

Since melatonin is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Melatonin may impair your thinking or reactions. Avoid driving or operating machinery for a least 4 hours after taking melatonin. This product may also affect your sleep-wake cycle for several days if you are traveling through many different time zones.

Avoid using melatonin with other herbal/health supplements. Melatonin and many other herbal products can increase your risk of bleeding, seizures, or low blood pressure. Using certain products together can increase these risks.

Avoid coffee, tea, cola, energy drinks, or other products that contain caffeine.

Using melatonin with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, medicine for anxiety or seizures, or herbal/health supplements may also cause drowsiness (tryptophan, California poppy, chamomile, gotu kola, kava, St. John's wort, skullcap, valerian, and others).

Do not take melatonin without medical advice if you are using any of the following medications:

• an antibiotic;
• aspirin or acetaminophen (Tylenol);
• birth control pills;
• insulin or oral diabetes medicine;
• narcotic pain medicine;
• stomach medicine--lansoprazole (Prevacid), omeprazole (Prilosec), ondansetron (Zofran);
• ADHD medication--methylphenidate, Adderall, Ritalin, and others;
• heart or blood pressure medicine--mexiletine, propranolol, verapamil;
• medicine to treat or prevent blood clots--clopidogrel (Plavix), warfarin (Coumadin, Jantoven);
• NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• steroid medicine--prednisone, and others.

This list is not complete. Other drugs may affect melatonin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your doctor, pharmacist, or health care provider may have more information about melatonin.

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