FDA Investigates Next-Day Safety of Sleeping Pills

[The Straight Story]

FDA Investigates Next-Day Safety of Sleeping Pills

May 17, 2011 — The US Food and Drug Administration (FDA) is taking another look at the risks of sedatives and their link to next-day effects, such as dangerous sleep driving.

In a 2-day expert panel workshop, the agency and the Pharmaceutical Education Research Institute hosted the event that evaluated the efficacy and safety of sedative hypnotic drugs.

"New concerns have arisen about the most appropriate way to evaluate both the safety and the efficacy of medications for insomnia," the FDA told Medscape Medical News in an email, "particularly given that they may differ in important characteristics, including both pharmacodynamic and pharmacokinetic properties."

The products are used to induce or maintain sleep but have also been linked to serious falls and sleep-related behaviors, such as driving while not fully awake. Other behaviors include sleep walking, making telephone calls, and having sex. Most people do not remember these events afterward.


http://www.medscape.com/viewarticle/742850