Many people take sedatives to help them sleep. The Food and Drug Administration (FDA) is reminding consumers that some drugs to treat insomnia could make them less able the next morning to perform activities for which they must be fully alert, including driving a car.
FDA has informed manufacturers that the recommended dose should be lowered for sleep drugs approved for bedtime use that contain a medicine called zolpidem. FDA is also evaluating the risk of next-morning impairment in other insomnia medications.
People with insomnia have trouble falling or staying asleep. Zolpidem, which belongs to a class of medications called sedative-hypnotics, is a common ingredient in widely prescribed sleep medications. Some sleep drugs contain an extended-release form of zolpidem that stays in the body longer than the regular form.
FDA is particularly concerned about extended-release forms of zolpidem. They are sold as generic drugs and under the brand name Ambien CR. New data show that the morning after use, many people who take products containing extended-release zolpidem have drug levels that are high enough to impair driving and other activities. FDA says that women are especially vulnerable because zolpidem is cleared from the body more slowly in women than in men.
FDA also found that some medicines containing the immediate-release form of zolpidem can impair driving and other activities the next morning. They are marketed as generic drugs and under the following brand names:
- Ambien (oral tablet)
- Edluar (tablet placed under the tongue)
- Zolpimist (oral spray)
FDA has informed the manufacturers of products containing zolpidem that the recommended dose for women for both immediate- and extended-release products should be lowered. FDA is also suggesting a lower dose range for men.
Drowsiness is already listed as a side effect in the drug labels of insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. However, people with high levels of zolpidem in their blood can be impaired even if they feel wide awake. “All insomnia drugs are potent medications, and they must be used carefully,” says Russell Katz, M.D., director of FDA’s Division of Neurology Products.