The FDA is advising makers of sleep drugs that contain zolpidem, including Ambien and Ambien CR, to lower the recommended bedtime dosages for women by half, because new data show that blood levels of the drug may be high enough the next morning to impair activities that require alertness (eg, driving).
Eight hours after taking extended-release zolpidem, a quarter of men and a third of women had levels higher than 50 ng/mg of blood.
The recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar and Zolpimist), and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR), the FDA said in a press release.
Healthcare providers should warn patients taking sleep aids that contain zolpidem that impairment can be present despite feeling fully awake.
Women are particularly susceptible to next-morning impairment, as they eliminate zolpidem from their bodies more slowly than men, according to the FDA. The agency is also recommending healthcare providers consider lower doses for men, and advises clinicians to prescribe the lowest dose necessary to treat a patient’s symptoms.
The recommended dosage for lower-dose zolpidem products (Intermezzo, Purdue), which is approved for middle-of-the-night awakenings, are not changing. The FDA is continuing to evaluate the risk for impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.