RESTING EASY FOR LESS: FDA APPROVES GENERIC AMBIEN

Pharmacy Times, Volume 0, 0

The FDA has approvedthe production of genericversions of sanofi-aventis'Ambien (zolpidem tartrate)immediate-releasetablets in 5-and 10-mgstrengths. Zolpidem tartrateis a sedative-hypnoticmedication indicated for theshort-term treatment of insomnia.Ambien was the 13th highest-sellingbrand name drug in the UnitedStates in 2006, with sales ofapproximately $2.2 billion for the12-month period ending December31, 2006, according to IMS Health.Sanofi-aventis'patent for the medicineexpired on April 21 of this year.

In March, the FDA called for allcompanies that produce sedative-hypnotic drugs such as zolpidemtartrate to revise their productlabeling to include strongerwarnings about potential adverseeffects, such as severe allergicreactions and complex sleeprelatedbehaviors, which mayinclude "sleep-driving."All 13companies approved by the FDAto manufacture generic Ambienwill be required to comply withthe labeling.