Dr. Richard Hoffmann, Ask the Pharmacist, 01/22/13

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FDA recommends change for insomnia drug

By Richard Hoffmann

Q: I heard the FDA is warning people about using a drug to help them sleep. What can you tell me about this?

A: On Jan. 10, the FDA notified the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends the bedtime dose be lowered, because new data show blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

The announcement focuses 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 also reminding the public 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.

The FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. 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. Because use of lower doses of zolpidem will result in lower blood levels in the morning, the FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist to lower the recommended dose. The 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 also informed the manufacturers that, for men, the labeling should recommend health care 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, a lower-dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription. To decrease the potential risk of impairment with all insomnia drugs, health care 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 health care professional.

If you are currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicine, continue taking your prescribed dose as directed until you have contacted your health care professional to ask for instructions on how to safely continue to take your medicine.

Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.

Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.