AASM position statement: Treating insomnia with over-the-counter sleep aids, herbal supplements

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 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 these 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

More research is needed to determine whether OTC medications produce measurable improvements in sleep.(3) Studies thus far have had small sample sizes and have focused on subjective reports rather than objective measures. Self-reports from patients have shown that OTC medications have helped them fall asleep. The risk involved with long-term use of these products, however, has not been studied.

The antihistamines used in OTC sleep aids can produce side effects such as the following:

  • Daytime sleepiness

  • Dizziness

  • Fatigue

  • Headaches

  • Reduced alertness

  • 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

Sufficient evidence does not exist to support over-the-counter (OTC) sleep aids as an effective treatment for insomnia. OTC sleep aids that contain antihistamine may provide modest, short-term benefits for adults with mild cases of insomnia. It is important to be aware, however, that the use of antihistamines may produce a variety of side effects.

Important Information Regarding OTC Sleep Aids

1. OTC sleep aids that contain antihistamine are approved by the FDA only for "occasional sleeplessness" by people who have trouble "falling asleep." These products are not intended to be used for more than a few nights or for severe cases of insomnia.
2. The information accompanying an OTC sleep aid should be read carefully.
3. OTC sleep aids are designed only for bedtime use.
4. OTC sleep aids should be taken only as directed by a physician or according to the instructions that come with the medication.
5. OTC sleep aids are not intended for use by children under the age of 12.
6. OTC sleep aids should not be taken with alcohol or with a sleeping pill, sedative, tranquilizer, or another antihistamine.
7. Pregnant or nursing women and individuals with breathing problems or glaucoma should consult their doctor before taking an OTC sleep aid.
8. Individuals should consult their doctor if they have either an ongoing problem with insomnia or another sleep problem that affects their daytime activities.

AASM Position Statement:
Treating Insomnia with Herbal Supplements

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

1. Herbal supplements should not be taken for the purpose of treating insomnia or any other sleep problem unless approved by a physician.
2. The use of herbal supplements presents a risk of dangerous side effects and adverse drug interactions.
3. Herbal supplements should not be used for any purpose by children under 12 years of age.
4. Pregnant or nursing women and individuals taking a medication should obtain approval from their doctor before using an herbal supplement.
5. 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.
6. It is prudent to seek help from a board-certified sleep specialist for a severe or ongoing sleep problem.

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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.

Background:

(1) Johnson EO, Roehrs T, Roth T, Breslau N. Epidemiology of alcohol and medication as aids to sleep in early adulthood. SLEEP. 1998;21:178-86.
(2) Hatoum HT, Kania CM, Kong SX, Wong JM, Mendelson WB. Prevalence of insomnia: A survey of the enrollees at five managed care organizations. Am J Manag Care. 1998;4:79-86.
(3) NIH Consensus Development Panel on Manifestations and Management of Chronic Insomnia in Adults. State of the science conference statement. SLEEP. 2005;9:1049-1057.
(4) Richardson GS, Roehrs TA, Rosenthal L, Koshorek G, Roth T. Tolerance to daytime sedative effects of H1 antihistamines. J Clin Psychopharmacol. 2002;22:511515.

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.
(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, Hackman RM. 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 States House 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.

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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