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Promotes Vigilance

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A Pill to Stretch Your Day
A new drug keeps people awake with no apparent ill effects. But is prescribing it the right thing to do?




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A Pill to Stretch Your Day
(STEPHEN SEDAM / LAT)

Quote

Prescribing the drug to workers who work long hours "becomes irresponsible. There might be fewer accidents on our highways, but there might also be long-term health consequences" associated with using Provigil "that we aren't anticipating."
-- JED BLACK
Director of the Stanford Sleep Disorders Clinic


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By TIMOTHY GOWER, Special to The Times


It has become a modern cliché: There aren't enough hours in the day. Americans are struggling to balance work and family commitments while trying to find time for a social life and recreation. A growing number of supermarkets, restaurants, gyms and other businesses are accommodating today's 24/7 culture by staying open all night. Not to mention, of course, that the Internet never shuts down. But what if you could do the same?

What if you could take a pill and stretch your day--by skipping sleep?

That sounds like the stuff of science fiction, but a drug called Provigil could make it possible. Studies have shown that this new medication allows people to remain awake and attentive when their bodies normally crave shut-eye, without suffering the unpleasant side effects and risk of addiction associated with caffeine, amphetamines and other stimulants.

Researchers caution that the long-term health consequences of avoiding slumber by taking Provigil, or any drug, aren't well understood.

And the makers of Provigil go out of their way to state that the drug is strictly for patients who feel sleepy during the day due to diagnosed medical disorders. Yet as its reputation grows, doctors may soon find themselves faced with a difficult question: When is sleepiness a sickness?

"This drug is going to bring up some very interesting ethical dilemmas," says Dr. Mark Mahowald, director of the Minnesota Regional Sleep Disorders Center in Minneapolis and an expert on the causes of daytime sleepiness. "Do you prescribe a stimulant medication for someone who is intentionally sleep deprived?"

Currently the U.S. Food and Drug Administration has approved Provigil only for the treatment of one condition, narcolepsy, which causes a sudden and uncontrollable urge to sleep. But Cephalon, the West Chester, Pa.-based company that sells Provigil, hopes to win FDA approval within a few years to market the drug as a pick-me-up for people plagued by sleepiness associated with any medical condition. Many doctors in this country already prescribe Provigil "off-label," that is, for conditions not approved by the FDA (which is a common and perfectly legal practice). Those conditions include depression, sleep apnea, Parkinson's disease and multiple sclerosis.

What's more, scientists at sleep clinics across the United States are studying whether Provigil can help those working the swing or graveyard shift, who are sometimes diagnosed with a condition known as "shift work disorder." Symptoms can include insomnia, headaches and an all-around blah feeling, in addition to problems staying focused on the job.

For 20 years, Jane Jaegers has worked the overnight shift as a 911 dispatcher for Santa Clara County--four days a week, 9 p.m. to 7 a.m. The San Jose resident loves the job, but her body has never adjusted to the odd schedule. In the wee hours of the morning, Jaegers says, her attention occasionally drifts during nonemergency calls. If she takes them in time, caffeine pills such as Vivarin and No-Doz help, but they leave Jaegers staring at the ceiling when she goes home and crawls into bed. Constantly exhausted, she has seen her social life suffer. Go to a movie? "As soon as the theater gets dark, I'm gone," says Jaegers, 55.

In December, Jaegers heard that scientists at the Sleep Disorders Clinic at Stanford University were studying Provigil, whose name is shorthand for "promotes vigilance." She signed up right away.

Every night before leaving for work, Jaegers takes two small tablets--she calls them "magic pills." Because half the people participating in the study are receiving placebo tablets, Jaegers can't be sure she's popping Provigil. But she thinks her pills are the real deal. "I just feel more alert," says Jaegers, who adds that she sleeps soundly these days too. "I'm tickled with the stuff."

Drug Is Not Classified as a Stimulant

Provigil was developed in France in the 1970s. Although no one is sure how it works, animal studies show that the medication--unlike other drugs that induce wakefulness--doesn't seem to dramatically increase levels of dopamine, a neurotransmitter associated with arousal and alertness.

Caffeine and older prescription stimulants buzz the entire central nervous system, causing jitteriness, insomnia and other unwanted effects. When people who use coffee or amphetamines to stay awake finally doze off, they often remain in bed for much longer than usual, their bodies paralyzed by the need for "rebound sleep." Provigil, meanwhile, seems to target only the part of the brain that keeps us awake. When its effects wear off, the user resumes a normal sleep pattern.

"Provigil isn't considered a stimulant per se, though it has a wakefulness effect," says Dr. Jed Black, director of the Stanford Sleep Disorders Clinic, who is involved in the shift-work study. Although Black says Provigil isn't effective for all patients, it helps many people haunted by daytime sleepiness keep on their toes. While a few users report mild nausea, most don't feel a thing other than awake and alert. When patients switch from older stimulants to Provigil, says Black, they often return to his office and say, "It's not working. I don't feel revved up." Yet tests usually show that their ability to stay awake is much improved.

Earlier research found that when healthy people take Provigil they are able to stay awake and on the ball for a long, long time. For example, a 1995 Canadian study showed that subjects taking the drug were able to perform well on cognitive tests while remaining awake and in good spirits for two and a half days. In another study, published in 2000, U.S. Army helicopter pilots stayed awake for 40 hours while being called upon periodically to perform maneuvers on a flight simulator. Unmedicated, the aviators became sloppy and made errors in the early morning hours. But while taking Provigil during a second 40-hour marathon, their skills and focus never wavered.

Army psychologist John Caldwell, who conducted the latter study, says more research is needed to determine whether dosing soldiers with Provigil is a safe and effective way to promote alertness. However, he says, it's possible that one day the drug could be used "as an emergency measure to briefly overcome fatigue in 'must-do' missions where total sleep deprivation is unavoidable."

What About Students and Working Parents?

But aren't many of us faced with our own "must-do missions" from time to time? If Provigil works for soldiers and pilots, won't it do the same for college students cramming for exams? Medical students on 36-hour rotations? Or a working parent with a sick child and a presentation to finish for tomorrow's big meeting with potential investors?

Cephalon spokesman Robert Grupp emphasizes that Cephalon has no plans to market Provigil to the all-nighter crowd. "It's not for people who work too long," he says. "It's for people with clinical illness." But as word spreads of Provigil's powers, it seems inevitable that the healthy-but-harried will be intrigued.

"Silicon Valley will go wild over this thing," says Andy Serwer, a columnist for Fortune magazine who admits to burning a fair amount of midnight oil when he's on deadline. Instead of swigging Jolt cola and espresso, software designers under the gun could simply take Provigil, which costs about $4 per pill--not much more than the price of a double latte.

But would executives pressure their employees to take a pill for the team? Possibly, says Serwer, if they heard that workers at other firms were pulling Provigil-fueled all-nighters. "You would be at a competitive disadvantage if you didn't," he says.

If any doctors have begun prescribing Provigil to college students and corporate workers under the gun, they're keeping the practice quiet. But Provigil does raise a difficult question for the medical community. What if people who work in positions where sleepiness can endanger themselves and others start asking their doctors for the drug?

Shift Workers Pose Dilemma for Doctors

Take long-haul truckers, for instance. According to federal regulations, they're supposed to take breaks every 10 hours. But many drivers ignore the law, even if it means navigating an 18-wheeler while bleary-eyed. A recent exposé by the Milwaukee Journal Sentinel featured an interview with one driver who admitted to being behind the wheel of his big rig for 36 straight hours.

"Do you give that person the medication to keep him awake and not kill himself and a car full of people?" asks Mahowald, of the Minnesota Regional Sleep Disorders Center. "Or do you as a matter of principle say, 'No, you cannot have this medication because you don't have the proper sleep disorder'? ... Quite frankly, in the interest of public safety, I would be tempted to give the individual stimulant medication."

Not all sleep experts feel that's the right choice. "I think that becomes irresponsible," says Black. "There might be fewer accidents on our highways, but there might also be long-term health consequences" associated with using Provigil "that we aren't anticipating." Black says he will only prescribe the drug to people whose sleepiness and fatigue are caused by a medical condition or occur as a side effect from another medication. However, Black, Mahowald and other sleep researchers agree that it's unwise to think Provigil or any pill will make shut-eye optional.

"We don't understand the role sleep plays," says the Army's Caldwell. "It's a bad idea for anyone to rely on a drug of any description to maintain alertness."

And yet for Jane Jaegers and other shift workers, Provigil may mean the difference between a zombie-like existence and a normal life. And they represent a huge potential market for Cephalon. The number of shift workers in the United States increases 2% to 3% each year, says David Mitchell, a spokesman for Circadian Technologies, a Lexington, Mass., company that advises firms that want to convert to 24/7 operation.

The nationwide shift-work study should be completed by the end of this year. If the results are promising, perhaps Provigil will one day be found in the medicine cabinets of police officers, firefighters, nurses and other people who work nights. And if that happens, what's to stop the son of a shift worker from asking, "Hey, Dad, I've got a history final on Tuesday--can I bum a Provigil?"

Then again, maybe Junior won't bother asking--the medication is on sale through Internet-based pharmacies based overseas, often marketed as a "smart drug."

In "Faster: The Acceleration of Just About Everything" (Vintage, 2000), author James Gleick writes about our changing notion of time. Reached by e-mail, he was dubious about using a drug to lengthen our days. "In a time-obsessed age, this is the Holy Grail," said Gleick. "Cheating sleep is the closest thing we have to cheating death." However, until scientists better understand the phenomenon known as sleep, he was quick to add, "Beware of miracles."
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