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Sales of Unique Stimulant Skyrocketing
July 8, 2004

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A growing number of people are using Provigil, a drug that boosts the central nervous system without the addiction and euphoria of amphetamines, the New York Times reported June 29.

The drug, which has been around since 1998, allows people to stay awake for hours or even days. Cephalon makes modafinil, which is marketed under the brand name Provigil. It has become attractive to millions of people because there are very few side effects, the worst being a mild headache or slight nausea.

But experts are concerned that modafinil is becoming a pick-me-up for college students, long-haul truckers, computer programmers, and others who need to push their bodies to stay awake in a culture of 24-hour stores and graveyard shifts.

"This drug enables us to be that much more workaholic and that much more obsessed with accomplishments and productivity, and I think our society is already extreme along those lines," said Dr. Martha Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania. "The natural checks on that tendency, like needing to go to bed, are being rolled back by modafinil."

Health experts said people taking Provigil might go undiagnosed for underlying diseases, such as diabetes or sleep apnea, that cause fatigue. Doctors warn that reducing sleep by even one hour a night could cause long-term neurological and cardiovascular effects.

"It's almost fortuitous that at the same time that this drug has come out, we have increasing mounds of data showing that sleep is a restorative, protective health process," said Dr. Neil Kavey, director of the Sleep Disorders Center at Columbia Presbyterian Medical Center. "It affects performance, blood pressure, heart rate, insulin, various hormone secretions. No matter what medications come out that make sleep seem like a waste of time, we know that the sleep-deprived state is a bad one to be in."

In 1998, modafinil was first marketed in the United States as a treatment for narcolepsy, a severe sleep disorder. Earlier this year, the Food and Drug Administration expanded its uses to include obstructive sleep apnea and sleeping problems caused by shift work.

However, data from Cephalon shows that 90 percent of all prescriptions for Provigil are "off-label" uses, including fatigue, depression, attention deficit hyperactivity disorder, and sleepiness caused by other prescription medications.

"The off-label use of this drug is staggering," said Dr. Eric Heiligenstein, a psychiatrist at the University of Wisconsin who studies drug misuse by teenagers. "This is a very clean drug that affects all the things that help people with their cognitive functioning. The main barrier to more widespread use is that it's expensive, which will change as more insurance companies start to cover it."

Worldwide sales of Provigil continue to grow. In 2003, sales totaled $290 million, up from $207 million in 2002. This year, worldwide sales are expected to reach $409 million.

"It is amazing that this drug has become so widely used without any real understanding of the basic science behind it," said Dr. Jerome Siegel, chief of neurobiology research at the Veterans Affairs Greater Los Angeles Healthcare System.

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