Jet Lag Drug Allows Travelers Be at 'Top of Game'

Jan. 12, 2010— -- Seth Miller logged 180,000 flight miles last year on 20 pleasure trips to countries like Korea, Egypt, Norway and Japan, and each time his feet hit the ground at a new destination, he fought off the exhaustion of jet lag.

"You maybe get four or five hours of sleep before landing early and you're expected to be functional when you get there," said Miller, who blogs about his travels on wanderingaramean.com.

"I take a shower and usually get a boost that pushes me through the day until about 8 or 9 at night before I am completely dead," he told ABCNews.com. "Even in business class, you're not on top of your game."

But his last trip -- all expenses paid to France -- was different.

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Miller, 32, was paid $2,500 by the Pennsylvania-based pharmaceutical company Cephalon to test Nuvigil, a stay-awake drug that could get FDA approval in March for a condition called "jet lag disorder."

Both the body and the brain become disoriented when travelers cross time zones and their circadian rhythm is disrupted.

Symptoms of jet lag are well known -- general malaise, daytime sleepiness, difficulty sleeping, impaired performance and gastrointestinal complaints. Traveling eastward, which requires advancing circadian rhythms and sleep-wake hours, is generally more difficult than going west.

Cephalon officials say jet lag can be dangerous if a traveler must drive a car upon arrival at a new destination, and some studies suggest that daily rhythms can contribute to obesity, mental illness and other ailments.

The company says Nuvigil is a wake-promoting agent that is structurally distinct from amphetamines and is believed to work selectively through the sleep- wake centers to activate the cortex of the brain. The drug promotes wakefulness without causing generalized stimulation in the brain, according to company officials.

An estimated 94 percent of American long distance travelers suffer from the effects of jet lag and 45 percent of them consider their symptoms severe, according to a 1998 survey published in Aviation, Space and Environment Medicine.

"Jet lag is hell," said Tork Buckley, editor of The Yacht Report, who travels once or twice a week from his home in France to the United States, Middle East and Far East. "It destroys the ability to concentrate, hampering reporting and any meetings I must attend."

Candace Steele Flippin, a spokesman for Cephalon, said jet lag disorder is a legitimate condition, classified by the International Classification of Sleep Disorders, along with "shift work sleep disorder" and narcolepsy. The FDA has already approved Nuvigil for treatment of those disorders.

"Jet lag disorder is an acute condition that's usually environmental," said Flippin. "For people who choose to fly across multiple time zones and are able to adjust, that's fine," she told ABCNews.com. "We provide a potential option that has been evaluated in robust clinical trials that might provide an option for those who don't have the time to let their circadian rhythms align."

Until Cephalon gets FDA approval, the company is looking at "all opportunities" to market the drug, according to Flippin.

Citing the 28 million Americans who travel overseas each year, according to the Department of Commerce, Flippin said the marketing plan would focus on those with "disruptive symptoms."

"A lot of people identify with individuals who travel on short trips abroad," she said.

They are seeking FDA approval only for eastbound travel.

The company-run trial that Miller participated in revealed some benefits, he said. There was some evidence of side effects for other participants, including headaches and nausea, according to the company.