FDA Issues Advisory On Sleeping Pills

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"All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy crashed his car after taking Ambien.

 

It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive -- with no memory of doing so.

 

The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports -- and is worried that more are going uncounted."

 

Full article can be found here.

 

 

A brief portion of the FDA's statement...

 

"The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event."

 

Full FDA statement can be found here.

 

 

Medications that are being requested to carry revised labels include 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)