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Published Online: Tuesday, May 1, 2007   [ Request Print ]

The FDA has approved the production of generic versions of sanofi-aventis' Ambien (zolpidem tartrate) immediate-release tablets in 5-and 10-mg strengths. Zolpidem tartrate is a sedative-hypnotic medication indicated for the short-term treatment of insomnia. Ambien was the 13th highest-selling brand name drug in the United States in 2006, with sales of approximately $2.2 billion for the 12-month period ending December 31, 2006, according to IMS Health. Sanofi-aventis'patent for the medicine expired on April 21 of this year.

In March, the FDA called for all companies that produce sedative-hypnotic drugs such as zolpidem tartrate to revise their product labeling to include stronger warnings about potential adverse effects, such as severe allergic reactions and complex sleeprelated behaviors, which may include "sleep-driving."All 13 companies approved by the FDA to manufacture generic Ambien will be required to comply with the labeling.

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