FDA suggests reduced dose for Zolpidem Sleeping Medications

Medicine bottle - BSN

(Best Syndication News) - The U.S. Food and Drug Administration (FDA) expressed concern for consumers who take certain medications containing zolpidem to treat insomnia. The medication could cause the user to be less capable at completing activities that require full attention, such as driving a vehicle.

Because of this concern, the FDA has notified the manufacturers of the sleep drugs containing zolpidem to lower the recommended dose. Zolpidem is marketed as a generic or under the brand names of Ambien (oral tablet), Edluar (tablet placed under the tongue), and Zolpimist (oral spray). Additionally, the FDA is currently trying to determine the risk of next-morning impairment in other sleep drugs and OTC products.

Some medicines that contain zolpidem have an extended release configuration that may stay in the body longer than the regular version. The extended-release version of zolpidem is available in generic and under the brand name of Ambien CR.

The FDA's concern is based on new data that demonstrated many people who take extended-release zolpidem have high enough concentrations of the drug in their system to affect their driving ability and other activities the next morning. Women are more susceptible to this problem; they had a higher amount of the drug in their systems longer than expected.

Additionally, the FDA found the immediate-release versions of zolpidem can affect the person’s ability to complete tasks such as driving a car the next morning.

To address these concerns, they FDA is asking the makers to reduce the dose for both the immediate (from 10 mg to 5 mg) and the time-released (from 12.5 mg to 6.25) forms. The FDA is also asking the manufacturers to lower the dose for men (5 mg for immediate and 6.25 mg for extended-release should be considered). However, Intermezzo remains the same at 1.7 mg for women and 3.5 mg for men.

Even if the person thinks they feel fully awake, zolpidem may still be present in high levels in the blood, which could impair the person’s ability to complete tasks that require full attention. People should follow the recommended sleep time when using zolpidem, and may want to consider adding extra time before driving a car.

By: Marsha Quinn
Health Reporter

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