Sleep aids' effects on drivers drawing regulators' scrutiny.
The first test for a new sleep drug is -- unsurprisingly -- how safely it puts people to sleep. Now comes a second test: how safely it lets people wake up.
The Food and Drug Administration is taking heightened interest in the issue, as new evidence suggests what many people have long suspected: the effects of common prescription sleep aids like Ambien can persist well into the next day. Of particular concern is whether people who take the drugs before bed can drive safely the next morning.
Consumer advocates have warned for years about possible links between sleep drugs and car accidents. In one prominent example, Kerry Kennedy, the former wife of Gov. Andrew M. Cuomo, was arrested last year after tests showed she had taken a generic version of Ambien before swerving her car into a tractor-trailer.
The FDA's actions are part of a robust national conversation about how to cope with the throngs of drivers who take to public roads every day under the influence of prescription drugs. Law enforcement authorities have struggled with how to prosecute those who are impaired, especially when they have a prescription. A government survey in 2007 found that nearly 5 percent of daytime drivers tested positive for prescription or over-the-counter medications.
Doctors wrote close to 60 million prescriptions for sleep aids in the United States last year, according to the research firm IMS Health, but experts say testing how these drugs affect driving is not easy. Nonetheless, the FDA has been unusually active.
Last month, it rejected an application by Merck to approve a new sleep drug, suvorexant, in part because tests showed that some people had trouble driving the next day. In May, the agency warned patients taking common allergy drugs like Benadryl against driving, noting that the sedating effects can sometimes last into the following day. In January, citing similar concerns, the FDA took the unusual step of requiring that all manufacturers of zolpidem, the generic name of Ambien, cut in half the dosage for women.
The agency has since said that it is taking a closer look at all insomnia drugs on the market, and will ask manufacturers to conduct more extensive driving tests for all new sleep drugs.
Part of the problem is that the standard warnings on many drugs -- against driving or operating heavy machinery -- are often brushed aside. "It would be so convenient and it would be so good if you could just tell people, don't drive unless you feel OK,'' Dr. Ronald Farkas, the clinical team leader for the FDA's division of neurology products, told a group of industry experts at a conference in February. "I think this has penetrated now that this is not adequate. It is still good advice that, if you feel impaired, don't drive. But if you feel fine, you might be impaired.''
For years, traffic safety officials have called, without success, for a so-called "safe list'' of drugs that do not affect driving. Some people react more strongly to drugs than others do, making it difficult to predict a person's individual risk. And driving tests can vary significantly, like studies conducted over public roadways or those done in computer simulators.
Pharmaceutical companies have long conducted driving tests for certain drugs, but the tests were motivated mainly by marketing goals and not seen as pivotal in getting a drug approved by the FDA, said Gary G. Kay, whose company, the Cognitive Research Corp., leases a driving simulator to pharmaceutical companies. Kay, for example, helped conduct some of the research showing that the allergy drug Claritin did not cause drowsiness.
Until recently, the FDA evaluated driving tests by looking at the reaction of the average patient. But that thinking has shifted as research has shown that some people react more strongly to drugs than others, Farkas said in a telephone interview. "Some people have higher blood levels than others, and some seem to be more sensitive than others,'' he said.
In 2011, the agency recognized this variability when it approved the sleep drug Intermezzo, which treats patients who wake up in the middle of the night, in two doses: one for men and a smaller dose for women. Data had shown that the drug's effects lingered in women for longer than they did in men. The agency's experience with Intermezzo, along with other research, led it to order in January that the dosage for all drugs containing zolpidem -- the active ingredient in Intermezzo, as well as Ambien and other generic sleep drugs -- be halved in women.
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|Publication:||Telegram & Gazette (Worcester, MA)|
|Date:||Aug 14, 2013|
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