McCain's Ambien Use: a Security Threat?

May 23, 2008— -- In a presidential race marked by references to preparedness in the face of the 3 a.m. call, the revelation that presumptive Republican nominee Sen. John McCain has taken the sleeping pill Ambien during his travels raises concerns that the rare side effects of the medication could impair his judgment.

"Taking more than the recommended dosage of Ambien or combining it with other sedative-hypnotics — for example, alcohol — may result in amnesia, fugue states and sleep walking," said Dr. Peter A. Fotinakes, medical director of the St. Joseph Sleep Disorders Center in Orange, Calif. "Used appropriately, Ambien is a relatively safe medication."

Though rare, such side effects associated with Ambien have made headlines.

Patients who claimed that they engaged in a bizarre variety of activities while asleep after taking the drug — from binge eating to driving their cars while asleep — lodged class action lawsuit in 2006 against Sanofi-Aventis, the maker of the drug.

The unusual side effects of the drug once again made headlines a few months later, when Rhode Island Rep. Patrick Kennedy smashed his Ford Mustang into a barrier near Capitol Hill. He later released a statement saying that he had been disoriented by two prescription medications he had taken, one of which was Ambien.

The U.S. Food and Drug Administration has uncovered more than a dozen reports of sleep-driving, all linked to the drug. Partly in response to such reports, the FDA urged sleep drug manufacturers on March 14, 2007 to strengthen their package labeling to include warnings of sleep walking, "sleep driving" and other behaviors.

Still, some sleep experts maintained that the rarity of these side effects, coupled with the wide use of the drug, make it unlikely that a problem would arise if the commander-in-chief were taking the pills.

"I suspect that drugs like Ambien are used very commonly by government officials, particularly when crossing time zones," noted Dr. Donald W. Greenblatt, director of the Strong Sleep Disorders Center at the University of Rochester Medical Center.