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| |  AASM Position Statement: Treating Insomnia With Over-the-Counter Sleep Aids, Herbal Supplements WINCHESTER, IL -- December 8, 2006 -- Insomnia is a common sleep complaint that affects about 30 percent of adults in the U.S. It occurs when a person has trouble falling asleep or staying asleep, wakes up too early, or feels unrefreshed after sleeping. It causes a variety of daytime problems, including fatigue, moodiness, and anxiety about sleep. The primary forms of treatment for insomnia are cognitive behavioral therapy (CBT) and prescription medications. Research shows that both of these treatment options can improve the quality and quantity of sleep for people with insomnia. Many other medications are sold in stores and online for the treatment of insomnia. They can be purchased without a prescription from a doctor. These nonprescription medications are regulated by the FDA as "over-the-counter" (OTC) drugs. FDA-approved OTC sleep aids contain a form of antihistamine as the active ingredient. "Histamine" is a chemical messenger in your brain that promotes wakefulness. Antihistamines typically produce drowsiness by suppressing the activity of histamine. The FDA permits the sale of OTC sleep aids that contain one of three types of antihistamine -- diphenhydramine hydrochloride; diphenhydramine citrate; doxylamine succinate. Some OTC sleep aids contain both an antihistamine and a pain reliever. Studies show that the use of OTC sleep aids is common. In one population survey of 2,181 adults, more than 10 percent of adults said that they used an OTC sleep aid in the past year.(1) Another survey of 3,447 adults found that 21.4 percent of people with daytime problems resulting from insomnia take an OTC medication to help them sleep.(2) Areas of Concern The antihistamines used in OTC sleep aids can produce side effects such as daytime sleepiness, dizziness, fatigue, headaches, reduced alertness, and vomiting. Daytime drowsiness can be severe in some people who use antihistamines, even when the medication is taken the prior day or night. Some side effects may be stronger in older people. A tolerance to the drug can develop in as little time as three to four days.(4) AASM Position Important Information Regarding OTC Sleep Aids AASM Position Statement: Treating Insomnia with Herbal Supplements Insomnia is a common sleep complaint that affects about 30 percent of adults in the U.S. It occurs when a person has trouble falling asleep or staying asleep, wakes up too early, or feels unrefreshed after sleeping. It causes a variety of daytime problems, including fatigue, moodiness, and anxiety about sleep. The primary forms of treatment for insomnia are cognitive behavioral therapy (CBT) and prescription medications. Research shows that both of these treatment options can improve the quality and quantity of sleep for people with insomnia. Many herbal supplements are marketed as products that promote and improve sleep. A scientific survey of 2,590 adults shows that three percent of herbal supplement consumers use the products as a sleep aid.(1) The sale of herbal supplements in stores and online is a multi-billion dollar industry.(2) Manufacturers of herbal supplements are responsible for ensuring the safety of their products and the accuracy of the information that appears both on the product label and in promotional materials. In contrast to drug products, however, herbal supplements may be marketed and sold without prior approval from the U.S. Food and Drug Administration. FDA regulations do forbid advertising that promotes an herbal supplement "as a treatment, prevention or cure for a specific disease or condition" such as insomnia.(3) Areas of Concern Evidence does show that the use of herbal supplements may have dangerous side effects. For example, in 2002 the FDA issued a consumer advisory that herbal supplements containing kava may be associated with severe liver damage.(5) The use of herbal supplements together with prescription medications also involves the risk of an adverse drug interaction. For example, in 2000 the FDA issued a public health advisory after a study showed a significant drug interaction between St. John's wort and certain prescription drugs. The FDA estimates that it receives reports of less than one percent of the severe, negative health reactions that occur with the use of dietary supplements.(6) FDA regulations require that a complete list of ingredients and the net contents of the product appear on dietary supplement labels. The FDA does not routinely analyze the content of herbal supplements, however, and independent analysis shows that the actual content of herbal supplements may differ significantly from what is listed on the product label. For example, one study found that most ginseng products contain less than half the amount of ginseng that is listed on the label.(7) In addition, the quantity of a supplement's ingredients may vary by manufacturer. The Federal Trade Commission regulates advertising for dietary supplements and in the past decade has filed more than 100 actions to challenge "allegedly false or unsubstantiated efficacy or safety claims for dietary supplements."(8) In recent testimony before a Congressional Committee, an FTC spokesperson warned, "Although many supplements offer the potential for real health benefits to consumers, unproven products and inaccurate information can pose a threat to the health and well-being of consumers and cause economic injury."(8) The FTC has been particularly concerned about the marketing of dietary supplements for use in children.(9) AASM Position Important Information Regarding Herbal Supplements 1. Herbal supplements should not be taken for the purpose of treating insomnia or any other sleep problem unless approved by a physician. REFERENCES: Position Statement: (1) Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA. Recent patterns of medication use in the ambulatory adult population of the United States: The Slone Survey. JAMA. 2002;287:337-344.
SOURCE: American Academy of Sleep Medicine
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