FDA lowers dosing for sleep drugs

Good night's sleep

The FDA has amended the current recommended dosage of zolpidem, the active ingredient in many commonly used sleep drugs. Zolpidem, found in sleep aids like Ambien, Edluar and Zolimist, is raising red flags over its potential to impair mental clarity the morning after using. New data from the FDA suggests that at the current recommended doses, zolpidem isn’t being eliminated from the blood in time for morning activities that require alertness, like driving. This is even more apparent in women, who reportedly eliminate zolpidem at a slower rate than men. Many zolpidem-based sleep drugs also come in extended-release form that, by design, stay in the bloodstream longer. These pose an even higher risk of impairing mental clarity the morning after taking.

“In addition, patients shouldn’t take a sleep medication intended for bedtime use late [at night],” said Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “They need to make sure that they have enough time that they can get a full night’s sleep, seven or eight hours.” For people who require taking sleep drugs in the middle of the night, Dr. Unger suggests a low-dose zolpidem product called Intermezzo. However, he cautioned that people should only take it if they have at least four hours of sleep time remaining.

By Marianne Hayes

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