The FDA has ordered labeling changes for more than a dozen sleeping pills, including such widely used meds as Ambien and Lunesta, as well as patient medication guides.

The move follows months of controversy over side effects, such as getting behind the wheel while still sound asleep, and severe allergic reactions. Given the widespread publicity over side effects and the aggressive marketing by some manufacturers (see ‘Why Johnny Can’t Sleep: No Rozerem!), this is overdue.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people. However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks,” says Steve Galson, who heads the FDA’s Center for Drug Evaluation and Research, in typically understated fashion.

FDA statement;
List of pills with new warnings and the manufactuers;
Bloomberg News;
Reuters;
CBS News report on Ambien and driving.

[tags]Abbott Laboratories, Ambien, FDA, Lunesta, Rozerem, Sanofi-Aventis, Sepracor[/tags]