1

FDA Requests Label Change for All Sleep Disorder Drug Products

These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. There have been several well documented cases of sleep driving as well as cooking, eating, and engaging in other tasks while the person is essentially asleep.

2

Involuntary Driving is Documented as a Side Effect

There have been a number of arrests for DUI in several states. Usually the person has taken the sleep aid, gone to bed, and then been arrested several hours later. Some time later the person realizes that he/she is under arrest and sitting in a jail cell in pajamas or a bathrobe. The defense of these cases usually requires a pharmacologist and fact witnesses, who can confirm that the person went to bed when they claim and/or that the individual has previously had trouble (e.g., sleep cooking or eating) after taking the medication.