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FDA Advises new Safety Recommendations and Dosage for Ambian

A pill bottle on a bedside table

The US Food and Drug Administration (FDA) recently announced new information regarding zolpidem, better known to the public as Ambien. The FDA is now recommending that the bedtime dose should be lowered due to new data that reveals the blood levels in some patients may be high enough to impair activities that require alertness, including driving, the morning after use.

It appears women are more susceptible to the risk of next day impairment due to women eliminating the zolpidem from their bodies at a slower rate than men. The FDA is now requiring manufacturers of Ambien, Ambien CR, Edluar and Zolpimist to lower their recommended dose to help combat this risk revealed from new data gathered from the FDA. The FDA has informed these manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for the immediate-release products and lowered from 12.5 mg to 6.25 mg for the extended-release products. The FDA strongly encourages all physicians to advise and caution all their male and female patients of this next day impairment that may occur after taking zolpidem.

These recent FDA safety recommendations come nearly 20 years after zolpidem was first approved to be on the market. Due to recent media publicity surrounding Ambien, most people are aware of the strange complex sleep-related behaviors that can result from taking zolpidem including patients getting out of bed and not being fully awake or aware of doing activities such as driving a car, preparing and eating food or having sex. Most people are not informed; however, that those who have taken zolpidem and then received a full night’s sleep (7-8 hours) could still be impaired the morning after use. Driving the morning after taking zolpidem can result in being charged with driving under the influence. Although the person driving may feel fine, the person could show signs of impairment that an officer can recognize and a subsequent blood test may reveal the drug still in the person’s system. If you or someone you love have been charged with driving under influence due to Ambien, it is essential you hire a skilled DUI defense attorney to review your case. Contact the Parker Law Center today for a free consultation! (800) 805-8804

Published by Parker Law Center in Drugs and Impairment. Attorney: Kellee Parker Harris.

This article provides general information, not legal advice for your situation. Every case turns on its own facts.

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