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Pharmacy Author:

Annette (Gbemudu) Ogbru, PharmD, MBA

Annette (Gbemudu) Ogbru, PharmD, MBA

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Melissa Conrad Stöppler, MD, Chief Medical Editor

Melissa Conrad Stöppler, MD, Chief Medical Editor

Melissa Conrad Stöppler, MD, is a U.S. board-certified Anatomic Pathologist with subspecialty training in the fields of Experimental and Molecular Pathology. Dr. Stöppler's educational background includes a BA with Highest Distinction from the University of Virginia and an MD from the University of North Carolina. She completed residency training in Anatomic Pathology at Georgetown University followed by subspecialty fellowship training in molecular diagnostics and experimental pathology.

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Pineal Gland Hormones

Pineal gland hormones include melatonin and ramelteon (Rozerem).

How pineal gland hormones work

Melatonin is a hormone produced by the pineal gland (located in the brain) during the dark hours of the day-night cycle (circadian rhythm). Melatonin levels in the body are low during daylight hours. The pineal gland responds to darkness by increasing melatonin levels in the body. This process is thought to be integral to maintaining circadian rhythm. Ramelteon is a prescription drug that stimulates melatonin receptors. It promotes the onset of sleep and helps normalize circadian rhythm disorders. It is approved by the US Food and Drug Administration for insomnia characterized by difficulty falling asleep.

Melatonin has been reported to be useful in the treatment of jet lag. Melatonin is believed to be effective when crossing five or more time zones, and is less effective when traveling in a westward direction.

Melatonin is also used in the treatment of insomnia in elderly patients who are melatonin deficient and have trouble falling asleep.

Melatonin has also been used for treatment of circadian rhythm sleep disorders in people who are blind and have no light perception.

Melatonin is available as over-the-counter and is not approved by the FDA for sleep disorders as it is considered an alternative medicine. Caution is advised that variations in quality, purity, and quantity of the active ingredient in natural pharmaceuticals make interpretation of clinical studies difficult and raises concerns about appropriate dose, drug interactions, and possible contaminants. Individual patients may or may not experience the reported benefits of melatonin. Slow-release melatonin products are reported to be less effective.

Who should not use these medications?

• Individuals who are allergic to melatonin products or ramelteon
• Individuals with severe liver impairment (cirrhosis)

Use: Swallow prescribed dose 30 minutes before bedtime on an empty stomach.

Drug or food interactions: Drugs that inhibit metabolism of melatonin and ramelteon, such as fluvoxamine (Luvox), may increase the risk for toxicity. Rifampin increases the metabolism of ramelteon, therefore decreasing its effectiveness. Melatonin has been reported to interfere with warfarin (Coumadin).

Side effects:

• Melatonin side effects may include low body temperature, headache, nightmares, and worsening of depression. It should be used with caution in individuals who have epilepsy, are taking warfarin (Coumadin), have autoimmune or endocrine disorders, or are pregnant or breastfeeding.
• Ramelteon side effects may include liver toxicity, dizziness, nausea, fatigue, headache, and worsening insomnia.

Pregnancy: Penal gland hormones are in Pregnancy Category C. This means there are no adequate and well-controlled studies in pregnant women for pineal gland hormones. Consult a physician to determine if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman as the effect of on a nursing infant is not known.