ZOLPIDEM-CONTAINING DRUGS FOR INSOMNIA INCREASE RISK OF NEXT-DAY TRAFFIC ACCIDENTS

January 14, 2013

Here is an important message for anyone using zolpidem (AMBIEN, AMBIEN CR, EDLUAR, INTERMEZZO, and ZOLPIMIST).

On January 10, 2013, the U.S. Food and Drug Administration (FDA) issued an apparently much-delayed safety alert concerning next-day sleepiness and the risk of traffic accidents caused by a group of drugs containing zolpidem. (AMBIEN is probably the most familiar brand name and the first in the group of zolpidem-containing drugs to have been approved by the FDA.) According to an article published in The New York Times the next day, the FDA said it had received approximately 700 reports of driving mishaps since zolpidem’s original approval, but it was not until reviewing driving-simulation studies with the form of zolpidem called INTERMEZZO (a formulation for patients who wake up in the middle of the night and have trouble falling back to sleep) that the agency belatedly linked high levels of this drug in the blood to traffic accidents.

Before it ultimately approved INTERMEZZO in November 2011, the FDA had twice rejected approval of the drug precisely because of these same concerns about high levels of the drug remaining in the blood the morning after the drug is taken and this fact contributing to car accidents. Other problems with zolpidem result from next-day memory loss of activities performed the night before (texting, eating, having sex).

In the 2011 approval process for INTERMEZZO, the FDA was aware of the higher levels of drug in the women’s blood, and the agency thus required a lower dose for women. However, one of the characteristics of zolpidem is that there is tremendous individual variation in how it is metabolized, meaning it is almost impossible to predict the level of drug in a given individual’s blood, how long the drug will stay in the body, and thus how any one individual would respond.

If you are taking one of the formulations of zolpidem (or other drugs for insomnia) you should talk to your health care provider about lowering the dose. Because clinical trials comparing active drug to placebo showed only a small difference in the time it took participants to fall asleep, patients should consider whether the benefits outweigh the risks.

Do not abruptly stop taking zolpidem or any other sleep medications without consulting your physician, because it is possible to become dependent on the drugs and experience subsequent withdrawal reactions.