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FDA Cracking Down On Sleeping Pill Dosage

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(Credit: KDKA)

(Credit: KDKA)

(Source: KDKA-TV)

Reporting Dr. Maria Simbra

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PITTSBURGH (KDKA) — Bizarre behaviors during sleep — eating, sex, even driving — have occurred on Ambien.

“There are some safety concerns with any drug like Ambien,” says Michael Korczynski, PharmD at Allegheny General Hospital.

More commonly, morning drowsiness is a concern.

“Theoretically, the way Ambien works is it should be out of your system after eight hours of sleep, but does everybody get eight hours of sleep? So when are you taking it, when are you waking up? So it doesn’t surprise me that some people might have some effects early when they wake up,” he continues.

The Food and Drug Administration is requiring the makers of Ambien and similar sleeping pills to lower the doses of their drugs.

The generic name is zolpidem. All versions of this medication will be affected. These include Ambien, Edluar, and Zolpimist.

Apparently, blood levels of the drug stay high enough to interfere with driving.

Women especially are at risk because they process the drug more slowly.

“As these drugs are out longer, we find out more about them that may not have occurred in the smaller numbers in clinical trials,” Korczynski says.

Poor performance on driving simulation tests of people with the medication in their system is pushing the FDA to make the lower dose recommendations.

For people who have trouble sleeping, the medication is meant for short term use only — two weeks or less. The idea is to get you into a routine so that you can sleep normally without medicine.

That means avoiding caffeine, going to bed at the same time every night, and making the bed inviting for sleep — so no TV or computer.

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