- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Lowers Recommended Ambien Dose
Agency cites risk of impaired activities morning after use for all insomnia drugs (Jan. 10)
The FDA has announced that it is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist — widely used sleep drugs that contain the active ingredient zolpidem — to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours, the agency says. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that healthcare professionals consider a lower dose for men. Data show that the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges healthcare professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
The FDA has informed the manufacturers that the recommended dosage 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). For men, the FDA has informed the manufacturers that the labeling should recommend that healthcare professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.
The FDA also reminded the public that morning impairment is not limited to zolpidem. Drowsiness is listed as a common side effect in the labels of all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. Moreover, alertness can be impaired even in people who do not feel drowsy.
The agency is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter products.
Source: FDA; January 10, 2013.