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

Contact: Jim Arcuri
American Academy of Sleep Medicine

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