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- Patient Comments: Insomnia Treatment - OTC Medicine
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Quick GuideInsomnia Pictures Slideshow: 20 Tips for Better Sleep
Melatonin (for example, Melatonex) is the only hormone available OTC for insomnia. Melatonin is a hormone produced by the pineal gland that helps regulate the body's clock or sleep-wake cycle. The secretion of melatonin is increased by darkness and decreased by light. The exact mechanism of how melatonin induces sleep has not been determined. Melatonin also decreases mental alertness and body temperature.
Melatonin is sold as a dietary supplement and is, therefore, not regulated by the FDA. It is commonly used for jet lag, insomnia, and sleep disturbances related to working night shifts. Some limited evidence suggests melatonin may be useful for treating sleep disturbances.
In 2005, MIT analyzed 17 peer-reviewed studies using melatonin. The analysis showed that melatonin was effective in helping people fall asleep at doses of 0.3 milligrams (mg). In some preparations the dosage of melatonin is significantly higher and these larger doses have shown to be less effective after only a few days of use. If possible, patients may want to stay with the same formulation or brand if it is effective for them.
If a person would like to try melatonin tablets, consult a doctor first.
Dosing: There is no established dose or time of administration. Individuals should follow the product labeling for dosing and administration.
Pregnancy and lactation: The use of melatonin during pregnancy or lactation has not been studied adequately. Based on past experience with other agents and the possibility of unknown risks to the fetus, melatonin should be avoided during pregnancy while breastfeeding. Consult your doctor before you use melatonin if you are pregnant or breastfeeding.
Children: The use of melatonin in children may be effective, particularly in children with disturbed sleep due to autism spectrum disorders. However, it should not be used as a first-choice treatment in children. Consult your pediatrician before giving your child melatonin for sleep.
Drug interactions: Although melatonin is sold as a dietary supplement, it should be thought of as a drug. It has side effects and may have drug interactions that have not been identified. The level of melatonin that the body produces is increased by certain drugs, such as selective serotonin reuptake inhibitor antidepressants or SRRIs (for example, fluoxetine [Prozac], sertraline [Zoloft], paroxetine [Paxil]) and monoamine oxidase inhibitors (for example, tranylcypromine [Parnate], phenelzine [Nardil]). The interaction between these antidepressants and melatonin used as a sleeping aid has not been assessed.
Side effects: The most common adverse effect of melatonin is drowsiness. Therefore, tasks that require alertness (for example, driving) should be avoided for four to five hours after taking melatonin. Melatonin also may also cause itching, abnormal heartbeats, and headaches. Melatonin appears to be safe when used short-term (less than three months). Long-term side effects of melatonin are unkown.
Melatonin is either derived from animal sources or synthesized in a laboratory. Melatonin obtained from animal sources has a higher likelihood of contamination, which can cause allergic reactions and viral transmission, than synthetic melatonin.
Melatonin may stimulate the immune system. People with severe allergies or other disorders that may be caused by an overactive immune system (for example, systemic lupus erythematosus, rheumatoid arthritis) should avoid using melatonin.
Other herbal products: Natural herbal supplements such as valerian, chamomile, kava kava, and others have been touted as remedies for insomnia; however, the safety or effectiveness of these products has not been documented. Consult your doctor before taking any herbal supplements to treat insomnia.