Background
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
There is limited scientific evidence to show that herbal supplements are effective sleep aids.[4] Anecdotal reports indicate that some herbal supplements may provide temporary aid to help individuals relax at bedtime.
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
There is only limited scientific evidence to show that herbal supplements are effective sleep aids. Because these products may be marketed and sold without FDA approval and may involve dangerous side effects or adverse drug interactions, they should be taken only if approved by a physician.
Important Information Regarding Herbal Supplements
- Herbal supplements should not be taken for the purpose of treating insomnia or any other sleep problem unless approved by a physician.
- The use of herbal supplements presents a risk of dangerous side effects and adverse drug interactions.
- Herbal supplements should not be used for any purpose by children under 12 years of age.
- Pregnant or nursing women and individuals taking a medication should obtain approval from their doctor before using an herbal supplement.
- Those who believe they may have suffered a harmful effect or illness from taking a dietary supplement should first consult their doctor and then report the problem to the FDA online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178.
- It is prudent to seek help from a board-certified sleep specialist for a severe or ongoing sleep problem.
About the AASM
The American Academy of Sleep Medicine (AASM) is the largest professional medical society for clinicians, researchers and other health care providers in the field of sleep medicine. The AASM is committed to promoting excellence in sleep medicine health care, education and research.
[1] Kaufman DW, Kelly JP, RosenbergL, 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.
[2] Natural Products Association. Facts about dietary supplements. Available at: http://www.naturalproductsassoc.org/site/PageServer?pagename="%20ln_NNFAIndustryFacts. Accessed November 16, 2006.
[3] Center for Food Safety and Applied Nutrition. Overview of dietary supplements. Available at: http://www.cfsan.fda.gov/~dms/ds-oview.html#safe. Accessed November 15, 2006.
[4] Meoli AL, Rosen C, Kristo D, et al, for the Clinical Practice Review Committee of the American Academy of Sleep Medicine. Oral nonprescription treatment for insomnia: an evaluation of products with limited evidence. J Clin Sleep Med. 2005;1(2):173-187.
[5] Centers for Disease Control and Prevention. Hepatic toxicity possibly associated with kava-containing products - United States, Germany, and Switzerland, 1999 - 2002. MMWR Weekly. 2002;51:1065-1067. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5147a1.htm. Accessed July 13, 2006.
[6] Center for Drug Evaluation and Research. FDA public health advisory: risk of drug interactions with St. John’s wort and indinavir and other drugs. February 10, 2000. Available at: http://www.fda.gov/cder/drug/advisory/stjwort.htm. Accessed July 14, 2006.
[7] Harkey MR, Henderson GL, Gershwin ME, Stern JS, HackmanRM. Variability in commercial ginseng products: an analysis of 25 preparations. Am J Clin Nutr. June 2001;73:1101-1106.
[8] Federal Trade Commission. The regulation of dietary supplements: A review of consumer safeguards. Prepared statement of the Federal Trade Commission. C. Lee Peeler, Deputy Director, Bureau of Consumer Protection, before the Committee on Government Reform, United StatesHouse of Representatives. March 9, 2006. Available at: http://www.ftc.gov/opa/2006/03/dietarysupplements.htm. Accessed November 16, 2006.
[9] Federal Trade Commission. Promotions for kids’ dietary supplements leave sour taste. Consumer Features. May 2000. Available at: http://www.ftc.gov/bcp/conline/features/kidsupp.htm. Accessed July 14, 2006.
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