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FDA Requiring Sleep Medicine Makers to Lower Doses

insomnia, sleep aids, sleep disorders, FDA

Because of risk of next-morning impairment, the US Food and Drug Administration is requiring manufacturers of certain sleep aids to lower doses in their prescription products. The makers of Ambien, Ambien CR, Edluar, and Zolpimist will need to reduce the amount of the active ingredient zolpidem and provide information about the risks involved with taking insomnia drugs.

Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep. The drug is considered a controlled substance, only intended for short-term use to treat insomnia.

New data show that zolpidem blood levels in some patients remain high the next morning and is enough to impair activities that require alertness, such as driving. The risk is greatest for those taking extended release versions of the medication. In addition, gender differences in the drug’s effective period have been noted. Women eliminate zolpidem more slowly than men. Lower doses of the drug will mean that less will stay in the bloodstream in the morning hours.

Dr. Ellis Unger MD, the director of the Office of Drug Evaluation at the FDA has said that the agency has received a number of reports of car accidents connected to zolpidem over the years. Although specific information is not available to tell how much of a role the drug played in those accidents, driving simulation studies indicate that there is impaired driving the morning after taking sleep aids containing zolpidem.

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A study published in the Journal of the American Geriatric Society finds that falls among the elderly are greater after taking zolpidem. The researchers at the University of Colorado at Boulder also noted cognitive impairments due to “sleep inertia” or grogginess that temporarily impairs working memory and decision-making.

Zolpidem drug manufacturers will be required to lower the recommended dose for women from 10 milligrams to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended release products (Ambien CR). For men, the new dose levels are not required, but labeling should recommend to physicians prescribing the drugs to lower doses to the lowest needed for active treatment.

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” said Dr. Unger. “Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate.”

Although this FDA action is centered on sleep aids containing zolpidem, all patients taking insomnia drugs, including those sold over-the-counter, should be aware of the morning-after risks. Talk with your healthcare provider to discuss your individual needs.

US Food and Drug Administration

Additional Resource:
National Institutes of Health