FDA Recommends Lower Bedtime Dose for Zolpidem

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The FDA is recommending that the bedtime dose for zolpidem be lowered because new data show that blood levels in some patients may be high enough the next morning to impair activities that require alertness (eg, driving). Zolpidem is a sedative-hypnotic medicine used in adults for the treatment of insomnia.

Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs, with women appearing to be more susceptible due to slower drug elimination than men.

This notification affects zolpidem products approved for bedtime use, both marketed under generics and the following brand names: Ambien (zolpidem tartrate tablets; Sanofi Aventis) , Ambien CR (zolpidem tartrate extended-release tablets; Sanofi Aventis), Edluar (zolpidem tartrate sublingual tablets; Meda), and Zolpimist (zolpidem tartrate oral solution spray; ECR). The FDA is requiring these manufacturers to lower the recommended dose.

As per the FDA, patients should be prescribed the lowest dose that treats symptoms. For women, the recommended dose should be lowered from 10mg to 5mg for immediate release products (Ambien, Edluar, and Zolpimist) and from 12.5mg to 6.25mg for extended-release products (Ambien CR). The recommended doses of Intermezzo (zolpidem tartrate sublingual tablets; Purdue) , a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo's approval in November 2011, the label already recommended a lower dosage for women than for men.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm.
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