Provigil: Downtime is over as pill offers 24-hour living
A single tablet of Provigil is said to make users feel as though they have just had a pleasant nap, even if they have not slept for many hours or even a day or two.
In America, the pill has been credited with fuelling the rise of the “24-hour society” by helping truckers, students, night-clubbers and international travellers stay awake through the night or cope with jet lag. The drug has achieved sales of about £250m a year.
Now the same thing may happen here. The Medicines and Healthcare products Regulatory Agency has quietly decided to loosen the tight restrictions governing who can be prescribed Provigil.
Until now, the drug has been given only to people with severe sleep disorders such as narcolepsy, where sufferers fall asleep at random.
The change means the drug can now be prescribed to people suffering much less serious problems such as “shiftwork sleep disorder” — a condition affecting some people who simply work erratic hours.
American users describe in enthusiastic terms how the pill has enabled them to stay awake without the jitteriness and anxiety brought about by large amounts of caffeine. Last week, Laurie Coots, 46, a marketing executive from Los Angeles, described how Provigil had helped her fight constant tiredness in the face of two overseas meetings a week, jet lag and sleepless nights.
“It was debilitating,” said Coots. “I couldn’t give an effective presentation because I was always shaky and nervous from being amped up on caffeine and stimulants . . . Without it (Provigil), my life would not be possible.”
Athletes have also put the stimulant to less reputable uses to boost performance. The US sprinter Kelli White, winner of the 100m and 200m at last year’s athletics world championships, will miss this summer’s Athens Olympics after testing positive for modafinil, the category of drug of which Provigil is a brand name.
Users of the medicine are supposed to take one or two pills a day to prevent them falling asleep at inappropriate times.
This weekend, however, experts were predicting that the drug could undergo the “Viagra phenomenon”, in which its main use would be to enhance lifestyles rather than treat a medical condition.
Professor Martha Farah, director of the centre for cognitive neuroscience at the University of Pennsylvania, said Provigil had already accelerated America’s trend to becoming a 24-hour society and would do the same in Europe.
“This drug enables us to be even more workaholic and obsessed with accomplishments and productivity,” she said. “It takes away the natural checks on that tendency — like needing to go to bed.”
Studies have shown that, in America, about 75% of people taking the pill do so for non-medical reasons, often to skip a few hours’ or a night’s sleep. It is popular with parents coping with young children, computer gamers and students facing exams.
Last year, about 17,000 Provigil prescriptions were written in Britain at a cost to the National Health Service of just over £3m. Both figures are expected to surge in the next two years.
Cephalon, the company behind Provigil, says it is horrified at the lifestyle “abuse” of its drug. Paul Blake, a British scientist who is Cephalon’s senior vice-president for clinical research, said: “Provigil is not a lifestyle drug. It is designed to help people suffering from sleep disorders.”
However, Cephalon’s earlier marketing materials told a different story. Two years ago it was reprimanded by the Food and Drug Administration (FDA) — America’s regulatory body — for the “dissemination of false or misleading promotional materials for Provigil”.
The FDA was alarmed by advertising material suggesting Provigil should be prescribed simply for tiredness, fatigue, lack of energy or “decreased activity”. These, it said, were “unauthorised uses”.
The FDA was also critical of Cephalon’s claim that Provigil was preferable to other stimulants, pointing out that since Cephalon had no idea how Provigil worked, it could not claim it was better or safer.
Blake concedes that two years later the company is still a long way from understanding its own product. He said, however, that scans on users’ brains suggested its main effect was on the part of the brain governing circadian rhythms, the brain activities that control sleep patterns.
By contrast, he said, other stimulants affected much wider areas and so were likely to have more side effects.
Most experts agree the drug does have far fewer unpleasant short-term side effects than amphetamine-based drugs — but they point out that little is known of its long-term impact.
Such warnings have not, however, diminished enthusiasm for Provigil among one customer — the military. Armed forces have experimented for years with different pharmaceutical methods for keeping soldiers, pilots and other key personnel awake and alert during long missions.
Cephalon’s existing customers include the British, American and French armed forces and it is understood that Provigil was widely used during the Iraq war last year.
Other research at Cambridge University has recorded the benefits of using Provigil. Barbara Sahakian, professor of clinical neuropsychology at the university, studied the effects of Provigil on 60 healthy young men, finding that those taking it became more alert, attentive and energetic. They also performed better in tests involving short-term memory and other brain functions.
Philip Murphy, a psychologist at Edge Hill College, part of Lancaster University, who specialises in the effect of drugs on behaviour, said people who were seeking such drugs should first take a close look at their lifestyle.
“If you are so busy you haven’t got the time to sleep, you should change your life — not take a drug,” said Murphy.
http://www.timesonline.co.uk