Generic Ambien Approved
A short-term treatment for insomnia
By Scott Roberts
MONDAY, April 23 (HealthDay News) -- The first generic versions of the popular sleep aid zolpidem tartrate, brand name Ambien, have been approved by the U.S. Food and Drug Administration.
In a statement, the agency said 13 manufacturers had been given license to produce 5-milligram and 10-milligram versions of the drug, which it cited as the 13th best-selling medication in the United States. The drug is sanctioned as a short-term treatment for insomnia.
Generic versions of Ambien will include the same warning label as the brand-name drug, the agency said. Warnings will include the potential for severe allergic reactions and what the FDA called "complex sleep-related behaviors," including the possibility of "sleep driving" while not fully awake.
The brand name drug is produced by Sanofi-Aventis, whose patent expired earlier this month.
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