FDA recommends lower dose of zolpidem for patient safety

In a drug safety communication, FDA has recommended that the bedtime dose of zolpidem, for the treatment of insomnia, 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 following brand-name drugs are affected: Ambien (sanofi-aventis), Ambien CR (sanofi-aventis), Edluar (Meda Pharmaceuticals), and Zolpimist (ECR Pharmaceuticals), as well as generic products approved for bedtime use.

FDA is requiring the manufacturers to lower the recommended dose of zolpidem 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).  FDA 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 recommended doses of Intermezzo (Purdue Pharma), a lower dose zolpidem product approved for middle-of-the-night awakenings, will not change. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.

FDA also has reminded the public that all drugs taken for insomnia can impair driving and activities that require 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 may 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.

FDA has urged healthcare professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.

FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter drugs available without a prescription.

To decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe 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.