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.

'Jet Lag is Hell'

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.

Nuvigil Tested on a Group of Travelers

Miller, an IT consultant from New York City, was one of 427 adult volunteers to participate in the Nuvigil study.

He spent four days in a sleep lab before boarding a Gulf Stream jet for France to ensure that his sleep patterns were "normal" -- no sleep apnea or other issues that would skew the study.

Once on board, volunteers were not allowed to drink alcohol, coffee or take sleeping pills. They could sleep, but were prevented from tilting their seats back, simulating a commercial economy flight.

After landing in Basil, Switzerland, at 7 a.m., half the volunteers were given Nuvigil and the other half got placebos. They were then whisked away to a French sleep lab for three days of tests.

"They hooked us up with crazy sensors and electrodes on our heads and gave us the drug and we got started," said Miller.

At four intervals during the day they were given a pill, and at the same intervals they were led to a darkened room to fall asleep and have their brain waves monitored. As soon as they slept, they were awakened again.

Those on the placebo fell asleep in an average of 3.4 minutes the first day, 6.2 minutes on the second day and 8.2 minutes on the third.

But those who got the highest dose of Nuvigil stayed awake for an average of 9.7 minutes the first day, 13.8 minutes the second day and 14.8 minutes the third.

The only side effect Miller noticed was jitters.

"I was trying to slide a piece on a jigsaw puzzle and my hands were shaking," he said. "I wouldn't take it for multiple days, but I would take it the first day I landed. Like any good drug, each person reacts differently."

Others reported trouble sleeping, headaches, nausea, palpitations and anxiety.

Any Better Than Coffee?

Many seasoned travelers have already found their own cures for jet lag -- coffee, sleeping pills and nutritional supplements like melatonin, a controversial hormone that can be taken in the days preceding travel.

But some research shows that if travelers miscalculate the right time to take melatonin, it actually makes jet lag worse.

"Realistically, you can't start to change to a new time zone before you leave," said Bill Ashton, founder of the Palo Alto, Calif.-based company Stop Jet Lag. "You have too much going on."

Ashton, whose familiarity with jet lag began in the 1970s as manager for the globe-trotting Al Stewart Band, developed software that creates tailor-made plans for travelers, taking into consideration their flight times and destinations.

Jet Lag Can Be Avoided Naturally

For $35,StopJetLag provides a personal profile that suggests when to sleep, avoid or seek bright light and even what to eat. The plan is based on the scientific work of the late Dr. Charles Ehret, director of Circadian Rhythms and Neurobiological Chronobiology at Argonne National Labs.

As for popping a pill, Ashton, 61, said "I think it's very hard for one thing to do it all."

Other critics say that using a drug to treat jet lag is just another example of medicalizing a natural condition.

"As a rule, I don't agree with taking something that is not natural to the body," said Andrea Fazzari, a portrait photographer in her early 30s who estimates that she only spends 10 days a month at her Manhattan home. The rest of her time she's traveling the world for her work.

"I actually do rather well with jet lag; I've learned to control it," she said. "Besides trying to sleep as best I can on my international flights, and not napping as soon as I arrive somewhere, unless it is already night of course."

She relies on a homeopathic product called Jetzone, an herbal concoction made of flower essences that is available from Whole Foods, to ease the jet lag.

Before travelers consider Nuvigil, they should avoid light at the wrong time of the day, sleep and exercise to accelerate adaptation to a new time zone, according to Dr. Phyllis Zee, director of the Sleep Disorders Center at Northwestern Memorial Hospital in Chicago.

The drug only addresses the symptom of sleepiness and not the underlying circadian misalignment, she told ABCNew.com.

However, for those who cannot function because of severe get lag, Nuvigil is a "step forward," said Zee, who did not participate in the study, but sits on an advisory board for Cephalon.

Meanwhile, Miller is headed for Seattle, Houston and San Diego on Jan. 22, then on to Hawaii, Las Vegas and London.

"I haven't asked for a prescription [of Nuvigil] because it isn't officially approved and I haven't been to the doctor for awhile," he said. "But next time I visit, I intend to ask for one."