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.
"Temazepam was used extensively to facilitate British troop transport to the Falkland Islands years ago," he added. "You may recall the talk of President Bush Sr. taking his "little blue pill" — Halcion — to help sleep when traveling. These drugs — Ambien less so than Halcion — have the potential to alter behavior and actions if the person taking them tries to stay awake."
Dr. Emmanuel Mignot, professor of psychiatry and behavioral sciences at the Stanford University School of Medicine, agreed that McCain's use of Ambien would likely pose little concern.
"It is perfectly legitimate to use Ambien when traveling," he said. "I would say that overall I would prefer to have a commander-in-chief well rested when he is traveling after taking Ambien rather than someone who is sleep-deprived because of jet lag.
"The only potential issue is if there is an emergency in the middle of the night, but honestly, I am not sure it is worse than being sleep-deprived there too. Of course, Ambien can have side effects, for example on memory — sleep deprivation too. Life is a trade off."
But while the overall risks of behavioral and judgment effects due to Ambien may be low, sleep experts agree that in a high-importance role such as the presidency, proper planning is needed when considering its use.
"Ambien should only be taken when you have a window of seven to eight hours for sleep," Greenblatt said. "Your staff should know that you've taken the medication, and that you should not be involved in any decision-making during that time."
Fotinakes added that sleeping pills and other sedatives have been proven to be more potent in the elderly. In light of this, he said, "It may not be the best idea for the commander-in-chief to be under the influence when he or she may have to make a snap decision regarding national security in the middle of the night; Hillary's so-called telephone call at 3:00 a.m."
Other sedatives — such as antihistamines and alcohol — could have similar effects, he added. "Yet, most people would not turn a hair if the president had a few shots before retiring to bed."
And as long as he is cautious in his timing, McCain may have little problem with the side effects of Ambien — a widely used drug which accounted for more than 45 million prescriptions in the United States in 2005.
"The key is to use Ambien-like sleeping medications in moderation and don't mix them with other sedative drugs or alcohol," Fotinakes said. "Most importantly, avoid use in the event you have to consider escalation from Defcon 4 to Defcon 3."