Sleep Drug Dosages Too High According To The FDA

Laboratory studies recently demonstrated that sleeping pills containing the ingredient zolpidem can leave patients drowsy in the morning at current dosages. The residual drowsiness increases the risk that takers of such pills will get into car accidents during an early morning drive. The studies caused the Food and Drug Administration to require drug manufacturers of sleeping pills including Ambien, Edluar and Zolpimist to reduce the recommended dosage for women by 50 percent. For men, manufacturers will now have to include new labels recommending that doctors “consider” prescribing the drug in a lower dose. The dosages for women were of particular concern because the drug is eliminated from the body more slowly in women than in men.

Sleeping pills are prescribed to millions of Americans every year. The use of such pills has grown in popularity in recent years. Sleeping pills were prescribed roughly 20 percent more frequently in 2011 than they were in 2006. This is not the first time sleeping pills have been tied to problems outside of direct health risks from the drug. Recently, use of the drugs was tied to an increased risk of falls suffered by patients staying in hospitals. Many hospitals are considering moving away from prescribing the pills and are instead using other methods to help patients sleep at night.

While reports of drowsy driving, unusual behavior and other problems suffered by people taking sleeping pills have circulated for years, the FDA chose to act now based on studies of the drug Intermezzo. When that drug was going through control trials for initial approval, driving simulation tests were done on its users. The tests showed by patients with blood levels of zolpidem that exceeded 50 nanograms per milliliter suffered an increased risk of car accidents.

Sleep driving is dangerous driving. For people who take sleeping pills at night, it is important to speak to your doctor about proper dosage to ensure that you are able to drive safely the next day.

Source: The New York Times, “F.D.A. Requires Cuts to Dosages of Sleep Drugs,” by Sabrina Tavernise, 10 January 2013