The FDA recommended the bedtime dose of zolpidem should be lowered because data showed blood levels in some patients might be high enough the morning after use to impair activities that require alertness such as driving.
Thursday's announcement focused on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.
The FDA is requiring the manufacturers of these drugs to lower the recommended dose. The FDA recommended the dose of zolpidem for women should be lowered from 10 milligrams to 5 mg for immediate-release products such as Ambien, Edluar and Zolpimist, and from 12.5 mg to 6.25 mg for extended-release products -- Ambien CR.
The FDA also informed the manufacturers for men, the labeling should recommend healthcare professionals consider prescribing the lower doses -- 5 mg for immediate-release products and 6.25 mg for extended-release products.
For zolpidem products, data showed the risk for next-morning impairment was highest for patients taking the extended-release forms of these drugs -- Ambien CR and generics. However, women appeared to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men, the FDA said.
The FDA emphasized all drugs taken for insomnia could impair driving and activities requiring alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients might still feel drowsy the day after taking these products.
Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake, the FDA said in a statement.