* The labeling of zolpidem products (Ambien and others) has been revised to reflect the risk of next-morning cognitive impairment.
* The recommended starting dose for women has been cut in half.
* Patients taking the extended-release form of zolpidem shouldn't drive or engage in other activities that require complete mental alertness the morning after taking the sleep aid.
The Food and Drug Administration (FDA) has revised the labels of formulations of zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist), a sedative-hypnotic used to treat insomnia. The information related to dosing recommendations and the warnings and precautions sections have been revised to reflect the drug's risk of next-morning cognitive impairment.
The recommended starting dose for women has been cut in half because women clear zolpidem from their bodies at a lower rate than men, making them more sensitive to the morning-after effects. Men may be started at either the lower or higher dose. However, the lower dose is likely to be effective, and using it will decrease the risk of adverse effects. For this reason, the label now states that all patients should use the lowest effective dose possible.
Circulating levels of extended-release zolpidem can remain high enough the next day to cause cognitive impairment. That is true whatever the dose, and the label of the extended-release form now also states that patients should not drive or engage in other activities that require complete mental alertness the morning after they take the sleep aid.
For some time, zolpidem prescribing information has noted that patients who take the drug are at risk for performing high-level activities during the night that they won't remember the next morning. Examples of such behaviors are driving a car ("sleep driving"), making and eating food, talking on the telephone, having sex, and sleepwalking. Patients are more likely to engage in such behavior if they also had alcohol or took other medicines to induce sleepiness. These warnings remain on the label.
Nurses should inform patients of the importance of taking as low a dose of zolpidem as possible and the risk of morning-after cognitive impairment, and instruct them and their families to be alert for the occurrence of unusual behavior during the night.
To read the FDA Drug Safety Communication regarding zolpidem, go to http://1.usa.gov/10w3jfb.