Other safety alerts
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| The United States: Drug Safety Communication - FDA Requires Lower Recommended Doses for Zolpidem Containing Products, 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 |
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The Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose 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. This 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.
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, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA advised 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). For men, FDA advised that 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, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing, as at the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.
FDA urges healthcare professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. And inform patients that impairment from sleep drugs can be present despite feeling fully awake.
FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm334738.htm
In Hong Kong, there are 14 registered pharmaceutical products containing zolpidem which include immediate-release 5mg or 10mg tablet and modified-release 6.25mg or 12.5mg tablet, and they are prescription-only medicines. Zolpidem is also controlled as psychotropic substances internationally including Hong Kong. According to the FDA’s recommendations, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, January 11, 2013
Issued at HKT 12:00
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