Pharmaceutical

FDA requires lower recommended dosage for insomnia drug Ambien

fda logo FDA requires lower recommended dosage for insomnia drug AmbienMany people who take the prescription sleep aid Ambien at bedtime still have high levels of the drug in their systems the morning after, which affects their alertness and impairs their ability to drive vehicles, the Food and Drug Administration (FDA) announced this week. The agency is requiring that the recommended dosage be lowered to reduce this risk.

Ambien and Ambien CR, which contain the active ingredient zolpidem, are sold both in brand name and in generic versions. Zolpidem is also the drug used in the sleep aids Ediuar, Zolpimist and Intermezzo. The FDA issued a safety communication that also reminds consumers that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use.

Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. People who take these drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

In products that contain the active ingredient zolpidem, the risk for morning-after impairment is highest for people taking the extended-release forms of these drugs, such as Ambien CR. Women appear to be more susceptible to the risk because they eliminate the zolpidem from their bodies more slowly than men.

Because use of lower doses will result in lower blood levels in the morning, the FDA is requiring manufacturers of Ambien, Ambien CR, Ediuar and Zolpimist to lower the recommended dose. The agency is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including ones sold over the counter without a prescription.

The FDA is requiring that the recommended dose for women be lowered from 10 mg to 5 mg for immediate-release products, and from 12.5 mg to 6.25 mg for extended-release sleep aids. For all other patients, the FDA recommends starting patients on the lowest possible dosage that treats the patient’s symptoms.

The recommended doses of Intermezzo, a lower dose zolpidem drug approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than men.

Source: FDA