New dosing recommendations for products containing zolpidem (Ambien, Ambien CR, Edluar) are now included in their labels, along with warnings of next-day hangover effects, the FDA said Tuesday.
The agency said it had formally approved label changes reflecting a safety communication it had issued in January, in which it warned that people taking the sleep inducer may still feel its effects the next day. The FDA had instructed manufacturers to rework the products' labels accordingly, with lower recommended starting doses.
Studies had shown that blood levels of zolpidem remained high enough to impair functional abilities, and the agency had received adverse event reports of patients -- particularly women -- not fully awakening the next morning.
Medication guides for the products will now include warnings of daytime confusion and sleepiness -- of which patients may not be aware -- after taking zolpidem the previous night. The guides also warn that patients may get up in the night without awakening and engage in activities that they don't remember the next day, including sex, food preparation, and even driving.
Following the recommendations issued in January, the new labels instruct clinicians and patients to start with doses of 5 mg in women and 5 or 10 mg in men for immediate-release zolpidem products. For Ambien CR, an extended-release form, the recommended starting dose is 6.25 mg in women and 6.25 or 12.5 mg in men.
When the lower doses prove to be ineffective, they can be stepped up, the FDA said. "However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness," the agency added in announcing the new labels.
The labels urge that patients taking Ambien CR, even at the lowest doses, avoid driving and other activities demanding full alertness the next day.