March 14, 2007
 
The US Food and Drug Administration (FDA) is asking manufacturers of sedative-hypnotic drugs to include stronger language in the drugs’ labels concerning the potential risks of these medications, including allergic reactions and problematic sleep-related behaviors, such as sleep-driving. 
 
Along with the labeling revisions, the FDA has requested that the drug manufacturers send letters to health care providers to notify them about the new warnings.
 
The FDA has also requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

The medications that are the focus of the revised labeling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

To read the press release from the FDA, go to http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html