Do You Have Excessive Sleepiness? Pharma Hopes So

Do you work in customer service? Health care? The restaurant industry? You might be suffering from shift work sleep disorder (SWSD) says a new ad campaign from Frazer, PA-based Cephalon who makes the Schedule IV stimulants Provigil and Nuvigil. One out of four people working nontraditional schedules suffers from this hitherto unrecognized epidemic say radio ads which broke this week in Chicago.

SWSD is characterized by trouble focusing, increased irritability and poor work performance -- think ADHD -- an accompanying web site, wakeupsquad.com, explains. But don't think the answer is renegotiating with your alarm clock. "Just improving your sleep may not improve your ability to cope with shift work," says the site which offers a self-assessment quiz and chance to "take action" and "tell a friend" without saying what that action might be or what you are telling your friend. No drugs are mentioned.

Of course shift work sleep disorder is only one reason for the national epidemic of excessive daytime sleepiness (EDS). Other reasons are obstructive sleep apnea (OSA) and narcolepsy -- Wink Wink -- for which Cephalon's drugs are also approved, non-restful sleep (NRS), restless legs syndrome (RLS) and middle-of-the-night insomnia (MOTN). You might also suffer from late night TV addiction syndrome (LNTVAS) or experience daytime sleepiness because --surprise -- what you are doing and the people you are with are Boring. (The reason they say speed makes people more interesting.)

Then there's all the people with sleepiness-from-treating-their-insomnia and insomnia-from-treating-their-sleepiness in a kind of pharmaceutical jet lag that began when insomnia meds like Ambien, Lunesta, Sonata and Rozerem first appeared on TV. Late night TV.

Sleeping pill hangovers are nothing new. In the 1960's, barbiturates, immortalized in the movie the Valley of the Dolls and by Marilyn Monroe's death, spawned a "bennie" or Benzedrine subculture to offset their effects. In 1993 the sleeping pill Halcion was banned in the UK and other countries for causing amnesia, paranoia, depression, hallucinations and violence in users. And in 2001, the related pill, Dalmane, was said to "increase the risk of an injurious accident more than five times normal," at FDA/National Transportation Safety Board hearings.

And who can forget Rep. Patrick Kennedy (D-Rhode Island) driving to Capitol Hill to "vote" at 2:45 AM on Ambien and crashing his Ford Mustang in 2006?

(In addition to sleep driving and sleep walking, Ambien is indicted for sleep eating -- horrified dieters finding themselves surrounded by Haagen-Dazs empties consumed by their evil twin in a blackout.)

Cephalon shouldn't have a hard time convincing people they have shift work sleep disorder or excessive daytime sleepiness judging from all the unprescribed Adderall, Vyvanse, Ritalin and Strattera people are taking -- and number of meth labs. Provigil "is increasingly being diverted for nonmedical use by healthy individuals with the expectation that it will improve cognitive performance," says an article in the March 18, 2009 JAMA. An article this week in the Daily Northwestern, Northwestern University's student paper, says college kids who've outgrown their ADHD can make a quick $300 a month flipping their Adderall and Concerta scripts on campus.

But the reason FDA rejected Provigil (modafinil) in 2006 for children with ADHD was not for its abuse potential but for its Stevens-Johnson Syndrome (SJS) potential -- a drug reaction so severe patients are treated in burn units and resemble Napalm victims.

Between 15 to 400 children were projected to die from SJS if Provigil (modafinil) were approved for ADHD in children at FDA advisory committee hearings in 2006 (attended by Joseph Biederman and Jorge Armenteros, later accused of drug industry conflicts of interest.) Provigil's molecular cousin Nuvigil (armodafinil) was also rejected by the FDA as a jet lag drug in March.

Still, an ad for a clinical trial for "excessive sleepiness associated with narcolepsy" in this week's University of Illinois student newspaper, the Flame, suggests that "Being sleepy throughout the day is more than just a nuisance, it's a heavy burden," and sleepy students might "suffer from Excessive Daytimes Sleepiness."

They may even have Study Shift Sleep Disorder.

ENDS

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