FDA Requires Labeling Revision for Zolpidem-Containing Sleep Aids

Medicare Set-Aside Blog on January 16, 2013 | Posted by


New information regarding the use of zolpidem-containing agents for the treatment of insomnia has prompted the FDA to require labeling revisions for manufacturers of Ambien (Sanofi-Aventis), Ambien CR (Sanofi-Aventis), Edluar (Orexo) and Zolpimist (NovaDel Pharma). Currently, the recommended dosage for zolpidem immediate release tablets, sublingual tablets and oral spray is 10mg per day. The recommended dosage for extended release zolpidem is 12.5mg per day. The FDA indicated that during the past several years, it has periodically received case reports of driving impairment and motor vehicle accidents for individuals who were taking zolpidem-containing products. These case reports prompted additional research in the form of laboratory studies and driving simulation exercises, in an effort to more fully understand the morning-after effects of zolpidem. This research has shown that, in some individuals, morning-after blood levels of zolpidem are high enough to affect mental alertness and impair the ability to drive. This has led to an increase in the risk of being involved in a motor vehicle accident. These findings are particularly concerning in women, who metabolize zolpidem more slowly than men.

As a result of these findings, the FDA issued a press release on January 10th regarding labeling revisions for zolpidem-containing products. Manufacturers of Ambien, Edluar and Zolpimist are required to change the recommended dosage of zolpidem for women to 5mg per day. Sanofi-Aventis is required to change the recommended dosage of extended-release zolpidem for women to 6.25mg per day. Additionally, the revised labeling should encourage health care professionals to consider lower dosages in men. The FDA press release further indicated that health care professionals are encouraged to discuss the potential for morning-after impairment for activities that require mental alertness, such as driving.

Old habits often die hard for physicians and other prescribers, and thus it may take some time for the new dosage recommendations to take hold. For workers’ compensation claimants with pain-related sleep difficulties, we may continue to see 10mg of zolpidem and 12.5mg of extended release zolpidem. But hopefully before too long, we will begin to see reductions in the dosage and associated cost of these medications within our MSAs.