Sleep Disorder Drugs Need Better Warnings

Paul Grieco

Contributor

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The Food and Drug Administration just issued a request that all manufacturers of sleep disorder drugs strengthen the labeling on the drugs in order to better advise users as to potential risks. The drugs and manufacturers that are included in the advisory are the following:
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)

The risks that are of specific concern at this time are severe allergic reaction, severe facial swelling, and complex sleep related behaviors such as sleep-driving and making phone call while sleeping. The FDA has also requested that manufacturers notify health care providers about the risks and the new warnings.