Drug beats sleep?

October 30, 2002

A DRUG designed to help people with a particular sleep disorder to stay awake could soon be licensed to perk up sleepy shift workers and others affected by drowsiness. The prospect is stirring up a debate about the dangers of popping a pill to counter a sleep-deprived lifestyle.

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," says Thomas Scammell, a sleep expert at the Beth Israel Deaconess sleep disorders clinic in Boston.

The clinical trial on shift workers is the latest of a string of studies showing how Provigil could benefit different groups of people. One study of military helicopter pilots showed that the drug helped them stay alert and capable of performing complex tasks for almost two days without sleep. Other studies have shown the drug seems to help patients with multiple sclerosis cope with fatigue. Ongoing trials are now looking at the drug's effect on tired truck drivers, medical staff and soldiers.

That the drug works so well is no surprise, as previous studies have shown it to be a potent stimulant. How it produces prolonged alertness is not well understood, but it is thought to act specifically in the brain's pre-frontal cortex. This is one of the most active areas of the brain in people who are awake, governing planning, memory and what we pay attention to.

The drug's localised effect may explain why it increases wakefulness without triggering the "wired" feeling of stimulants such as coffee and amphetamines. Surprisingly, tests also found that when the drug wore off, there was no noticeable need for an extended sleep to recover.

Critics of more widespread use of Provigil fear that the drug might give people a false sense that they can cheat their need for sleep, while in reality they may be accumulating a sleep debt that will ultimately harm them. Sleep deprivation leads to cognitive impairment, as well as seriously disrupting the immune and hormone systems, although it is not known how long these effects last. And Paul Blake of Cephalon acknowledges Provigil's limitations: "The drug isn't a replacement for sleep," he says.

On the other hand, Provigil could help prevent accidents common among shift workers, and make a big difference to soldiers on sustained operations or rescue workers at a major emergency. "It's an interesting challenge for society and for the FDA," says Neil B. Kavey, director of the Sleep Disorders Center at Columbia-Presbyterian Medical Center in New York. "We have to make sure nobody's going to get hurt," he says.

New Scientist issue 2nd November 2002


US CONTACT - Michelle Soucy, New Scientist Boston Office: Tel: 617-558-4939 or email michelle.soucy@newscientist.com

New Scientist

Related Sleep Articles from Brightsurf:

Size and sleep: New research reveals why little things sleep longer
Using data from humans and other mammals, a team of scientists including researchers from the Santa Fe Institute has developed one of the first quantitative models that explains why sleep times across species and during development decrease as brains get bigger.

Wind turbine noise affects dream sleep and perceived sleep restoration
Wind turbine noise (WTN) influences people's perception of the restorative effects of sleep, and also has a small but significant effect on dream sleep, otherwise known as REM (rapid eye movement) sleep, a study at the University of Gothenburg, Sweden, shows.

To sleep deeply: The brainstem neurons that regulate non-REM sleep
University of Tsukuba researchers identified neurons that promote non-REM sleep in the brainstem in mice.

Chronic opioid therapy can disrupt sleep, increase risk of sleep disorders
Patients and medical providers should be aware that chronic opioid use can interfere with sleep by reducing sleep efficiency and increasing the risk of sleep-disordered breathing, according to a position statement from the American Academy of Sleep Medicine.

'Short sleep' gene prevents memory deficits associated with sleep deprivation
The UCSF scientists who identified the two known human genes that promote 'natural short sleep' -- nightly sleep that lasts just four to six hours but leaves people feeling well-rested -- have now discovered a third, and it's also the first gene that's ever been shown to prevent the memory deficits that normally accompany sleep deprivation.

Short sleep duration and sleep variability blunt weight loss
High sleep variability and short sleep duration are associated with difficulties in losing weight and body fat.

Nurses have an increased risk of sleep disorders and sleep deprivation
According to preliminary results of a new study, there is a high prevalence of insufficient sleep and symptoms of common sleep disorders among medical center nurses.

Common sleep myths compromise good sleep and health
People often say they can get by on five or fewer hours of sleep, that snoring is harmless, and that having a drink helps you to fall asleep.

Sleep tight! Researchers identify the beneficial role of sleep
Why do animals sleep? Why do humans 'waste' a third of their lives sleeping?

Does extra sleep on the weekends repay your sleep debt? No, researchers say
Insufficient sleep and untreated sleep disorders put people at increased risk for metabolic problems, including obesity and diabetes.

Read More: Sleep News and Sleep Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.