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Carol Eustice

FDA Cuts Recommended Dose of Ambien

By January 10, 2013

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Many people with arthritis have difficulty sleeping. They may have trouble falling asleep or staying asleep because their pain is not well-controlled. Some patients resort to sleep medications, such as Ambien (zolpidem), to help overcome the problem.

Today, the U.S. FDA announced that it has recommended lowering the bedtime dose of zolpidem products. Why? Data has revealed that blood levels in some patients remain high enough the morning after the medication is taken to impair activities that require alertness. The products are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. The FDA is requiring manufacturers of these drugs to lower the recommended dose.

The data showed that the risk for morning-after impairment is highest for people who take the extended-release forms of these drugs and for women. Men seem to eliminate the drugs from their body more quickly than women. Lower doses of zolpidem will result in lower blood levels the following morning. According to the FDA, the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). The recommended dose of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, will not be changed.

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