Provigil, as the drug is known in the US and Britain, is approved for treating the daytime sleepiness associated with the rare condition called narcolepsy, which makes people fall asleep involuntarily. But last week, the drug's manufacturer, Cephalon of West Chester, Pennsylvania, announced results from a clinical trial of 209 shift workers that showed it helps those with "shift work sleep disorder"- excessive sleepiness caused by odd working hours.

The trial is part of Cephalon's attempt to expand the range of conditions Provigil can be used for. Ultimately, the company hopes it can be prescribed to treat sleepiness that results from any medical condition, and plans to submit data from this and other trials for approval for such use to the US Food and Drug Administration (FDA) this year.

But critics fear that this could lead to the use of Provigil being extended from those with sleep disorders to healthy people who are simply sleep-deprived. While experts differ as to whether shift work sleep disorder is a real medical condition, it is clearly caused by lifestyle. Police, hospital staff, pilots and people who work at all-night stores are among the countless groups of workers likely to be affected. Get the drug approved to treat such people and the decision whether to treat those who are simply working or playing too hard becomes a distinctly grey area.

Some fear there would then be little to stop Provigil becoming the elixir of choice for the 24/7 generation. Several sleep researchers told New Scientist that patients with demanding careers and lifestyles are beginning to ask for Provigil to help them stay alert as they burn the midnight oil. "It's happening already,"
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Contact: Claire Bowles
claire.bowles@rbi.co.uk
44-207-331-2751
New Scientist
30-Oct-2002