In focus: FDA scrutiny of sleep aids and driving impairment
American Academy of Sleep Medicine
Wednesday, August 14, 2013
A new commentary from the FDA Center for Drug Evaluation and Research provides the context for recent FDA decisions focusing on zolpidem and driving impairment. Published online in the New England Journal of Medicine on Aug. 7, the editorial provides an overview of the FDA’s efforts to understand how the risk of driving impairment related to zolpidem can vary among individuals. “Quantitative analyses of the relationships among drug dose, blood levels, and driving impairment…are likely to be of growing interest (and perhaps debate),” the authors write.
An article published Aug. 13 in The New York Times notes that the FDA’s concerns about drowsy driving caused by prescription medications is not limited to insomnia drugs such as Ambien. However, sleeping pills are a target because doctors wrote nearly 60 million prescriptions for sleep aids in the U.S. last year. The challenge is that it is difficult to predict a person’s individual risk of driving impairment, and driving tests can vary significantly.