A popular sleep medication, zolpidem, which is marketed as a generic and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist, has been found to impair driving and other activities that require alertness the morning after use. In addition, the morning-after impairment is greater in women than men. As a result, on January 10, the Food and Drug Administration (FDA) issued a report that recommended that the bedtime dose of zolpedin should be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
The FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. The drug label already contains a warning that drowsiness is a common side effect and that individuals who take the medication at bedtime mays still feel drowsy the day after taking these insomnia medications. In addition, individuals who take these medications may experience impairment of mental alertness the morning after use, even if they feel fully awake.
The FDA stresses that healthcare professionals should warn all patients, both men and women who take zolpidem, about the risks of next-morning impairment for activities that require complete mental alertness, including driving. Studies have found that the risk for next-morning impairment after taking zolpidem is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). In addition, women are more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.
Taking a lower dose of zolpidem will result in lower blood levels in the morning; therefore, the FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA has informed the manufacturers that 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 has also informed the manufacturers that, for men, the labeling should recommend that healthcare professionals consider prescribing the lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products).
The FDA does not recommend lowering the standard dose of Intermezzo, which is a lower dose zolpidem product approved for middle-of-the-night awakenings. At the time of Intermezzo’s approval in November 2011, the label recommended a lower dosage for women than for men.
The FDA notes that it is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription. The agency also cautions that to decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe––and patients should take––the lowest dose capable of treating the patient’s insomnia. Patients who drive or whose activities require full alertness the morning after use of an insomnia drug should discuss the appropriateness of their medicine with their healthcare professional.