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FDA Calls for Stronger Warnings Over Possible Reactions to Sleeping Pills

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Associated Press
March 15, 2007

Makers of sleeping pills such as top-selling Ambien and Lunesta should stiffen warnings on allergic reactions and behaviors such as sleep-driving, the Food and Drug Administration said yesterday.

All medicines prescribed to help induce and maintain sleep should use stronger language about these potential risks in their package inserts, the FDA said in a statement. Americans spent $3 billion last year on prescriptions for Ambien and Lunesta, the two most heavily advertised drugs in the United States. Though sleep aids are well tolerated by many people, regulators and consumer advocates have raised concerns that these increasingly popular medicines are more dangerous than consumers realize.

The FDA recommended that drug manufacturers conduct clinical studies to determine how often side effects occur.



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