FDA: Lower Ambien’s Dose to Prevent Drowsy Driving — Blood levels from nighttime dose of sleep aid can remain too high the next morning, agency says

In an effort to reduce daytime drowsiness, the U.S. Food and Drug Administration approved lower-dose labeling of Ambien (zolpidem). This is in order to make driving safer.

This is in response to the FDA’s January request to manufacturers that zolpidem drugs include instructions to lower the recommended dosage and give more safety information to patients.

“FDA approved these changes due to the known risk of next morning impairment with these drugs,” said the agency in a Tuesday statement posted on its website.

Ambien, AmbienCR, Edluar, and Zolpimist are all sleep medications that contain zolpidem.

“The purpose of the lower is to help reduce the risk of next morning impairment of activities that require alertness,” Dr. Ellis Unger from the FDA’s Center for Drug Evaluation and Research stated at the time of the FDA’s request to manufacturers. We are particularly concerned about driving. Driving is a dangerous activity that is practiced by a large portion of the population.

The nighttime dose will be lower, which means that there will be less drug in the blood when the person wakes up. The FDA stated that extended-release drugs tend to remain in the body for longer periods.

Manufacturers have been advised by the FDA to reduce their recommended doses of women’s immediate-release drugs (Ambien, Edluar, and Zolpimist) to 10 mg to 5 mg and 12.5 mg to 6.25 for extended-release products like Ambien CR (Ambien.

The agency asked manufacturers to modify the labeling for men to suggest that doctors and other health-care professionals prescribe lower doses. This would mean 5 mg for immediate-release and 6.25 mg respectively for extended-release.

Unger explained that women are more at risk of next-morning impairments because they remove zolpidem more slowly from their bodies.

It is not clear why women remove the substance more slowly than men.

Unger stated that although there have been some reports of adverse reactions, such as motor vehicle accidents, possibly due to Zolpidem, this link is not likely to be established.

He explained that new driving simulation studies showed that current prescribed levels of zolpidem drugs may cause alertness problems the next day.

FDA will require driving simulation studies for new sleep medication, and is currently evaluating other medications that treat insomnia. Unger stated that eventually, the FDA will require driving-simulation studies for all new sleep medications.

Unger stressed that next-day impairment does not only apply to medications containing Zolpidem, but also to all other sleep medications.

He said, “Doctors should prescribe all sleep medication and patients should take the lowest possible dose.”

He stressed that people who are taking any type of sleep medication shouldn’t change their dosage without talking to their doctor.

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Updated 01/24/22