The FDA has informed manufacturers that the recommended dose for medications containing zolpidem should be lowered. Zolpidem is a sedative-hypnotic medication and a common ingredient in many common sleep medications.
The FDA is particularly concerned about extended-release forms of zolpidem because they stay in the body longer. New data shows that people taking these medications have drug levels that are high enough to impair driving. Women are especially vulnerable to these effects because zolpidem is cleared from their bodies slower than in men.
These medications are sold as a generic drug under the brand name Ambien CR. The FDA also found that some medications containing the immediate-release form of zolpidem can impair driving. They are marketed as generic drugs under the following brand name:
Although drowsiness is listed as a side effect along with warnings of next day drowsiness, people with high levels of zolpidem in their blood can be impaired even if they feel awake. “All insomnia drugs are potent medication, and they must be used carefully,” says Russell Katz, MD, director of the FDA’s Division of Neurology Products.
The FDA has informed manufacturers that the following changes should be made:
Zolpidem is one of the most common active ingredients in prescription sleep aids. It has been on the market for nearly 20 year and about nine million patients have received it from retail pharmacies in 2011.
The FDA’s Adverse Event Reporting System has logged approximately 700 reports of zolpidem used and impaired driving ability and accidents. The FDA cannot be certain the accidents are cause by zolpidem along. Many of the reports lack information such as dosage, time of day taken, time of the accident, and alcohol or drug use of patients.
The FDA is urging health care professionals to properly warn patients about the risks of next-mroning impairment while on these drugs. The agency recommends that people who take sleep medications talk to their doctors about ways to take the lowest effective dose.
Patients are asked to contact the FDA’s MedWatch program if they suffer side effects from the use of zolpidem or another insomnia medication.