Makers of widely used sleep aids such as Sanofi’s Ambien have been told to reduce by half the recommended doses for women after U.S. regulators found lingering effects of the drugs in the morning hours.
Sleeping pills containing the ingredient zolpidem stay in the body, particularly women’s bodies, longer than previously thought and can impair activities such as driving, the Food and Drug Administration said today in a statement. The decision was based partly on driving simulation studies for Transcept Pharmaceuticals Inc.’s lower-dose zolpidem drug Intermezzo approved in November 2011, the FDA said.
Recommended doses will be cut in half to 5 milligrams for women who take immediate-release products and to 6.25 milligrams for women on extended-release formulations. Labels on the drugs, of which there were 39 million prescriptions dispensed in 2011, will suggest doctors consider lower doses for men as well.
“FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving,” the agency said in the statement.
Other zolpidem-containing drugs include Meda Pharmaceuticals Inc.’s Edluar and NovaDel Pharma Inc.’s Zolpimist. Ambien and Ambien CR also come in generic versions. There are no labeling changes needed for Intermezzo.
“We agree that individuals taking zolpidem should always talk to their doctor about the most appropriate dose,” Jack Cox, a Sanofi spokesman, said in an e-mail today. He said the Paris-based company has been in contact with the FDA about Ambien dosing and that there is “significant clinical data demonstrating the safety and efficacy” of the drug, which was approved in the U.S. in 1992.
Women make up 63 percent of patients taking zolpidem-containing drugs, Ellis Unger, director of the FDA’s Office of Drug Evaluation I in the Center for Drug Evaluation and Research, said in a telephone interview.
The FDA is continuing to evaluate the risk of decreased mental alertness with other sleep drugs, including over-the-counter treatments, the agency said in the statement.
Merck & Co. is working on suvorexant, part of a potential new class of treatments known as orexin receptor antagonists that aim to have fewer side effects, including driving troubles.
The FDA has told companies that reviewers will require driving studies as part of any new applications for sleep drugs, Unger said.