Melatonin is a hormone secreted by the pineal gland in a 24-hour circadian rhythm, regulating the normal sleep/wake cycle. Increased secretion occurs during the hours after dark. It decreases neopterin release, counteracts apoptosis, and increases thymus activity. Adults experience a 37% decline in daily melatonin output between 20-70 years of age. Melatonin has been effectively used by individuals suffering from insomnia, particularly when adjusting to staggered work cycles or jet lag. In addition to promoting sleep, the physiological role of melatonin includes regulation of the secretion of the growth and gonadotropic hormones. It also possesses antioxidant activity.

Pharmaceutical Form:
Tablet.
White-colored coated round tablet with bisect on one side of the tablet.
NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.

Pharmotherapeutic Group & Information:
Melatonin is a hormone secreted from the pineal gland in a 24 hour circadian rhythm, regulating the normal sleep/wake cycle. Increased secretion occurs during dark hours; decreases neopterin release; counteracts apoptosis; increases thymus activity. Adults experience a 37% decline in daily melatonin output between 20-70 years of age. It has been used by individuals suffering from insomnia, particularly when adjusting to shift-work cycles or jet lag.
In addition to promoting sleep, physiological function of of melatonin include regulation of the secretion of growth hormone and gonadotropic hormones. It also possesses antioxidant activity.

Therapeutic Indications:
Therapy for jet lag and insomnia. Can be taken by children 15 years and older as directed.

Contradictions:
This drug is contraindicated in the case of history of allergy to any of the ingredients.
The use of this drug is inadvisable during pregnancy or when nursing.

Warnings:
No known toxicity or serious side effects. Excessive dosages may cause morning sedation or drowsiness.
Keep this product out of reach and sight of children. In case of accidental overdose, call a doctor or poison control center immediately.

Special Warnings:
Because no data are available, the use of this drug by pregnant women or nursing mothers is unadvisable.
Central nervous system: Drowsiness, dysphoria (especially in depressed patients), giddiness
Gastrointestinal: Nausea
Miscellaneous: Fixed drug eruption.

Interactions:
Drugs that deplete vitamin B6 may inhibit the body's ability to synthesize melatonin from the tryptophan-serotonin-melatonin pathway. These include oral contraceptives, estrogen, hydralazine, loop diuretics, penicillamine, and theophylline. In addition, beta-blockers and benzodiazepines may deplete melatonin by enzyme inhibition. Isoniazid alters vitamin B6 metabolism, limiting formation of melatonin. Theoretically, effects may be additive with medications which cause CNS sedation.
A deficiency of pyridoxine inhibits the synthesis of melatonin.

Recommended Intake:
Jet lag: 1-2 tablets (at 18:00 hours) for 1 week starting 3 days before the flight
Insomnia: 1-4 tablets 30-40 minutes before sleep.
Tablets must be swallowed with water.

Expiration Date:
Manufacturing and expiration dates appear on the label and box. After the expiration date some of the products ingredients may diminish in strength.

How Supplied:
Bottles of 30 tablets: NDC 362900-1624-30; blisters of 12 tablets: NDC 362900-1624-12 and 2 blisters of 12 tablets or one blister of 24 tablets: NDC 362900-1624-24. Tamper-evident seal under the cap and a full-body clear seal are used for bottles.

Storage Condition:
Store this product in its original packaging for 3 years. Do not expose to temperatures above 30^oC (86^oF).


These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.