Melatonin oral dosage forms

What are melatonin oral dosage forms?

MELATONIN is a hormone that the body produces. Melatonin performs many functions; some functions are not well understood. It is known that the melatonin in the body contributes to the natural regulation of sleep during night hours. Melatonin products are used to help some people who have difficulty maintaining normal sleep patterns. While melatonin is claimed to be helpful for other problems related to hormones and aging, there is no proof at this time that melatonin is effective for such uses. Melatonin products are either chemically synthesized or are from animal sources, such as cattle. The use melatonin products from animal sources is not recommended due to the risk of viral contamination of these products. Melatonin is available over-the-counter as a nutritional supplement from many manufacturers.

What should my health care professional know before I use melatonin?

It is important for you to tell your prescriber or other health care professional that you are using melatonin. Some hormones exert potent effects and may interact with other drugs you are taking.

You should discuss melatonin with your health care professional BEFORE taking it if you have any of these conditions:

• are a frequent user of alcohol or have a history of drug abuse

• difficulty sleeping

• heart, kidney or liver disease

• history of emotional illness, such as anxiety or depression

• immunosuppression, or if you are receiving treatment for cancer

• seizure disorder (convulsions) or any other neurologic condition

• an unusual or allergic reaction to melatonin, hormones, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Follow the directions on the package labeling, or talk to your health care professional. Most forms of this medicine should be taken orally (i.e., swallowed). Sublingual tablets should be placed under the tongue or between the cheek and gum and allowed to dissolve. Do not chew sublingual tablets. If you are taking an extended release form of melatonin, do not crush or chew the tablets or capsules. Aerosol spray forms of this medication should not be inhaled into the lungs, but sprayed into the mouth.

Self-treatment with melatonin should not continue for longer than 2 weeks without the advice of a health care professional.

Contact your pediatrician or health care professional regarding the use of this hormone in children. Special care may be needed.

What if I miss a dose?

Missing a dose is probably not harmful. If you miss a dose, simply resume taking it on your previous schedule. Do not take double doses to catch up, however.

What drug(s) may interact with melatonin?

• amphetamine and dextroamphetamine

• blood pressure medicines such as nifedipine

• herbal dietary supplements like kava kava or valerian

• hormonal medications

• medications for depression, anxiety, or other emotional or psychiatric problems.

• medications for treating seizures (convulsions)

• medications for sleep

• tamoxifen

• treatments for cancer or immune disorders

For many over the counter products sold as nutritional supplements, interactions with other medications are unknown. That is why you should always be careful when mixing these remedies with traditional medications. If you take any other medications, consult with your health care professional prior to taking melatonin.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking melatonin?

Since some melatonin products can be derived from animals, particularly cattle, allergic reactions are possible. Stop using this hormone if you develop a rash. You may want to see your health care professional, or inform them that this occurred.

Melatonin may cause drowsiness. Driving or operating machinery, or performing other tasks that require mental alertness requires caution when taking melatonin. You should not participate in these activities until you determine how melatonin affects you.

Do not drink alcohol while taking melatonin. Alcohol might increase side effects.

Do not use melatonin without approval from your health care professional if you are currently being treated for a mental or emotional problem such as depression or anxiety. Melatonin might interfere with your treatments. Also do not stop your prescribed treatments without talking to your prescriber or health care professional.

Self treatment should continue for no longer than 2 weeks. You should contact your health care professional for advice prior to prolonged use.

Different brands of melatonin might contain different amounts of active ingredient so be careful to use the same brand. It is recommended that you use a brand from a reliable manufacturer and one that has been standardized. A standardized product is more likely to contain the same amount of hormone from dose to dose. Your health care professional or pharmacist can assist you in finding a standardized product.

What side effects may I notice from using melatonin?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• confusion, forgetfulness

• depressed mood, nervousness, or other mood changes

• difficulty staying awake or alert during the day

• rash

• rapid heartbeat or "palpitations"

• shortness of breath or difficulty breathing

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

• drowsiness, dizziness

• headache

• upset stomach

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature; do not freeze. Throw away any unused medicine after the expiration date.

GENERAL INFORMATION REGARDING DIETARY SUPPLEMENTS:

Dietary supplements include amino acids, hormones, vitamins, minerals, herbs, and other plant-derived substances, and extracts of these substances. Products are easy to identify as they must state "Dietary Supplement" on the label. A "Supplement Facts" panel is provided on the label for most products. Supplements are not drugs and are not regulated like pharmaceuticals. You should note that rigid quality control standards are not required for dietary supplements. Differences in the potency and purity of these products can occur. Scientific data to support the use of a dietary supplement for a certain condition may not be available. 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.

• Look for products containing ingredients with the "USP" notation. This indicates the manufacturer followed the standards of the US Pharmacopoeia.

• "Natural" doesn't mean a product is safe for humans to consume.

• Supplements produced or distributed by a nationally known food or drug company are more likely to be made under tight controls as these companies have standards in place for their other products. You can write to the company or manufacturer for more information about the conditions under which the products are made.