Here’s a thoroughly modern ethical dilemma to chew over. You go for a job interview but are pipped to the post by another person who seems wholly underwhelming and is less well qualified. The feedback is that she came across as more zappy and focused. Over coffee, she shares that she’s popped a tab of Ritalin before the interview. How does that make you feel?

Or here’s another one. Senior members of the academic department that you work in share their tip for being able to fly over to the US and deliver a lecture the same day while looking fresh and sounding perky.

They regularly take the drug Modafinil to counter jet lag and enhance their cognitive function. You’re not keen, but as a junior member of the team, you want to perform as well as possible. So do you try to get your GP to prescribe some or, like most of your workmates, buy some on line?

These challenges aren’t theoretical but real. Cognitive-enhancing drugs, also known as “smart” drugs are already being used to help people with Alzheimer’s disease, schizophrenia, attention deficit hyperactivity disorder (ADHD) and brain injury. But is there burgeoning use among university students and others wishing to boost their brain power? It is this that’s posing the ethical dilemmas.

Barbara Sahakian, professor of clinical neuropsychology at Cambridge University, described how the smart drugs fit in to our quest to keep our minds functioning longer and better in our ageing population, in a lecture last night at the Royal Institution, organised by Prospect magazine.

The three drugs in common use are methylphenidate (Ritalin), modafinil (Provigil) and atomoxetine (Strattera). All boost neurotransmitter chemicals (noradrenaline, acetylcholine, dopamine) at the junction between nerves to improve transmission or electrical activity.

Even modest improvements in cognitive function can make a big difference to people’s lives. It can make the difference between someone with schizophrenia being able to live independently or not. Or a kid with ADHD being able to stop his impulsive behaviour and stay out of trouble at school. And there are huge financial implications in being able to reduce the cost of long-term care for people with Alzheimer’s if a drug can slow their cognitive decline by even 1%.

Professor Sahakian said that the smart drugs are just one approach to boosting cognitive function. Exercise (three brisk walks a week will do, she said) and learning new things throughout life are most important. And connecting with others, giving of yourself and maintaining your curiosity about life are the other cornerstones of mental wellbeing.

She warns against the potential dangers of people under 20, whose brains are still developing, taking smart drugs like Ritalin unless they have a condition such as ADHD. But an estimated 16-20% of US college students take smart drugs and there is reason to believe its spreading to the UK.

The field of neuroethics is developing to look at challenges posed by advances in the neurosciences. Some arguments for smart drugs include removing disparity in society and boosting performance. In a lengthy operation, it is best to have one surgeon do the whole job and a tab of Modafinil may be better than caffeine which, in high doses, can cause tremor.

The US army is interested in smart drugs to allow troops to complete military operations as quickly as possible. But the potential harms include the fact that we don’t know about long-term effects, especially in developing brains. People may feel coerced into taking them. There’s a potential for abuse and you may get unwanted effects like persistent memories. Is it cheating to take the drugs? Will it turn us into mechanistic beings who don’t feel we’ve earned the right to feel proud of our achievements? Will working hard and being motivated become antiquated concepts? Will we become a homogenous society and will we lose creativity?

The last concern is practical. There is no licence for prescribing smart drugs unless you have a specified condition. No self-respecting GP is likely to prescribe it. And buying drugs online is fraught with dangers. You have to check you have no contraindications, that it won’t interact with any other medication and that what you get in the post is what it says on the box.

First published in UK news paper ‘The Guardian’

http://www.guardian.co.uk

Mark often faced the decision of studying to earn an A or going out to party with his friends.

In the end, Mark, a recent College of Liberal Arts graduate, who asked that his real name not appear in print, never had to make that decision, but he had to break federal law to make the grade.

The answer to Mark’s problem lay in a roommate’s medicine cabinet: Adderall.

“This stuff is all-American. It’s everything we value,” he said. “The side effects are probably limited, it makes us more productive and it’s focused on academics, making us better-functioning members of society.”

Mark isn’t alone. Where students once relied on caffeine, some are now turning to more potent solutions such as Adderall.

University of Minnesota students’ use of the drug as a study aid raises fresh concerns over the safety of nonprescription drug use, but some are questioning the fairness of neuroenhancement in classrooms where the difference between one student’s A and another student’s B may lie in a $5 pill.

A cure for Facebook

Possession of drugs without a prescription is against state and federal law, but at the University, nonprescription use of neuroenhancers lands in a gray area between policies.

Illegal possession of drugs is against the University Student Conduct Code, but neither that code nor the academic misconduct policy specifically addresses neuroenhancing drugs as they affect academic performance.

In the 2009 Minnesota College Student Health Survey, 7 percent of students at nine Minnesota colleges reported that they used prescription drugs without a prescription. The survey did not specify exactly which types of prescription drugs students were using.

In other college polls, as many as a quarter of students have reported using neuroenhancers as a study aid.

Lee Penn, an associate professor of chemistry, said she sees lots of students who have difficulty studying for tests.

Penn recommends that students distance themselves from potential distractions when they are studying. That means no television, no cell phone and, if possible, no computer.

“I think, in general, people who [cram] end up trapping themselves into doing it by flittering away their time by staying on the Internet or Facebooking in an addictive fashion,” Penn said.

And that’s exactly the sort of distraction that Steve, a CLA sophomore, who asked that his last name not appear in print, said Adderall helps him block out.

“When I’m studying without it, I’ll check Facebook and whatnot,” Steve said. “When I’m on it, I don’t even think about anything else. I’m just focused on studying.”

‘A few calls away’

Adderall, Ritalin and Provigil all belong to a class of drugs sometimes called neuroenhancers. They’re often prescribed as a treatment for attention deficit disorder and attention deficit hyperactivity disorder, but they can be a boon in last-minute study sessions and for those who have more work than time.

The drugs haven’t been widely studied in people without ADD/ADHD, but physicians say their addictive potential is high.

Dr. Gary Christenson, director of Mental Health Services at Boynton Health Service, said that element of uncertainty alone should give students pause.

Users sometimes experience jitters, a loss of appetite and increased heart rate. In rare cases, the drugs can cause severe heart conditions and stroke.

Thorough assessments for ADD/ADHD include tests of intelligence, short-term memory and planning. The tests detect over- and under-compensation to eliminate healthy individuals who are simply looking for a prescription.

For physicians, prescribing neuroenhancers means striking a precarious balance between covering all those with ADD/ADHD while limiting the number of people with prescriptions who don’t have the conditions.

“We don’t have X-rays for this,” said Dr. Ken Winters of the University Department of Psychiartry.

But those who want the drug have been known to circumvent the rigorous testing by going to primary care physicians who often don’t have the time or the means to perform the methodical and expensive examination.

“If you say the right symptoms — everyone can figure that out by going on the Internet — you might be able to convince somebody you have a problem,” Winters said. “For ADHD you can do cognitive ability tests that help determine whether somebody really has an attentional problem or not. That probably isn’t done often in a lot of clinics.”

Mark said his roommate was prescribed the drug while in high school “before this Adderall panic.”

That roommate knew exactly what to tell his doctor in order to get a stronger dosage that had a higher street value, Mark said.

“He doesn’t really need them. He can study fine without them.”

Those with prescriptions can become targets for 11th-hour cramming, and there is an expectation that prescriptions will be shared, Mark said.

“It’s kind of like being a freshman in the dorms who has a fake ID. You’re just expected to buy booze for your friends.”

But those who have prescriptions sometimes hide that fact so they aren’t pressured into selling their drugs.

An Institute of Technology junior, who asked that his name not be used, said he hides his Adderall prescription from friends because he doesn’t want to be pressured into selling.

Mark agreed that the precedent for selling can drive some with prescriptions underground.

“If I had a prescription, I would probably keep it on the hush,” he said.

Even if those with prescriptions are hiding that fact, the drug is never more than “a few calls away,” Mark said. “There’s definitely not a problem finding it at all.”

Mark’s friends often asked him why he used the drug instead of planning and studying in advance — instead of “being responsible.”

“We don’t want to,” Mark said. “We want to kick it. We want to chill and then [study] at the last minute because we can.”

Scholastic arms race

All the Adderall users interviewed for this story denied that the drug gave them an edge in the classroom.

They all said Adderall simply allowed them to reach their full potential.

“I’m not relying on it to get through class or anything,” Steve said. “It’s not like you take it and you become smarter.”

Mark praised Adderall for giving him the energy to go through college without sacrificing free time or his social life for grades.

“Adderall was really rad because I could go out and party and have a bunch of fun pretty much every night of the week, and then the day before a test, or the day before a report, I would say, ‘I’m going to take some Adderall and crank it out.’ ”

Christenson said that using the drug without a prescription should raise questions.

“Stimulants give you a better ability to focus, a better ability to concentrate and they’re also energizing, so that would give an advantage to someone who, for all intents and purposes, had the same skills and talents.”

But some students and professors question the absolute fairness of the academic setting.

One College of Design junior who has a prescription for Adderall said the drug “does make things easier” for users, but she said that whether it is fair is irrelevant.

“There are some people that naturally are able to read things, like business textbooks, and focus the whole time,” she said.

“I think [Adderall] levels out the playing ground, because the people that are able to do this stuff aren’t the ones that are trying to take it.”

On the other side of the gradebook, professors said drugs may be a game-changer.

“We shouldn’t be talking about competitive academics, and yet we are because it’s always about the bell curve,” Penn said. “My gut response is that it’s not fair.”

Penn said classes already tilt in favor of students with better education, but the introduction of drugs shreds any possibility of a fair assessment.

“People ought to be bringing a true and faithful representation of how hard they work to the exam situation, and if you take drugs that make it easier to take the test, it’s not a true and faithful representation of who you are.”

From a medical perspective, Winters said Adderall use is morally ambiguous.

“That’s an ethical dilemma, and from a fairness standpoint, one could draw a line in the sand and say, ‘That isn’t acceptable.’ ”

The issue may be akin to a scholastic arms race.

As students resort to more extreme measures, their peers may feel the need to do the same or risk lagging behind, Christenson said.

“Why should someone feel compelled to take a medication and accept the potential risks of any medication that they take just because someone else is doing it?” Christenson said.

First published http://www.mndaily.com

Josh has an exam and, like most of the other boys at his prestigious public school, he’s keen to put his best foot forward. He’s eaten breakfast and dressed smartly, but before he sets off for class, he reaches for a white pill and pops it into his mouth.

He bought 30 of the tablets online for £40 from the U.S., but for all Josh knows they might well have been knocked up in an illegal backstreet ‘pharmacy’ in India.

Still, the drug modafinil – usually used to treat sleeping disorders – has worked before for him and if it works again he is sure to get top marks.

Welcome to the world of ‘smart drugs’, otherwise known as cognitive enhancement pharmaceuticals.

This is a world where pupils as young as 15 self-medicate, participate in illegal online drug trafficking and swap notes on the best pill cocktails for good grades.

Concern over smart drugs has been growing for some time among academics, politicians and pharmacologists, but it has been brought

into sharp focus with the announcement that the former health minister, Lord Darzi of Denham, is heading a study at Imperial College, London, into their effects.

This might seem odd because most of these drugs have been around for decades for the treatment of conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, and have been found to be safe.

But no one has monitored their chaotic use in healthy young people taking inappropriate doses to boost their intellectual prowess.

And some experts believe this kind of use in brains that are still developing could cause addiction and permanent damage.

Josh is an intelligent, articulate 17-year-old, so you wonder why he needs extra help to feel smart. He has been taking modafinil (sold as the prescription-only drugs Provigil, Alertec, Modavigil and Modalert) since he was 16, but has friends who began using smart pharmaceuticals at 15. He lives in London and his parents are lawyers.

‘I read about modafinil in a newspaper and then researched it on the internet and spoke to some of my friends about it,’ he says.

‘It appealed to me as an inexpensive method for highly concentrated revision, for which I would otherwise depend on coffee, tea or Red Bull. Modafinil gives you heightened alertness, stamina and productivity. I find it helpful for focus and memory.

‘I find I can memorise a graph after drawing it once instead of several times. I would say it makes me 40 to 50 per cent more productive in a day, but it does not make me any cleverer.

‘While revising for my last set of exams, I was taking 100mg of modafinil a day for six or seven days a week for three weeks.

‘Around half-term, I stepped it up to 150mg to 200mg a day and in the last two or three weeks up to the exams I took 200mg to 300mg a day and worked 18-hour days.

‘I find you can get by on four to six hours of sleep for up to three weeks and then, at the end, the body needs to rest and catch up. I take a whole day off and sleep for 24 hours.

‘Taking it is no different from having other stimulants such as coffee, ProPlus caffeine tablets or Red Bull. It is no different from taking painkillers for a headache.

‘I use it specifically for exams and will carry on at university. I would recommend it to anyone who is informed about it and knows what they are doing.

‘I haven’t told my parents about using modafinil. They wouldn’t know what it is and they wouldn’t approve of me using it.’

Josh’s use of modafinil is not unusual. A quick scan of student web forums uncovers a world where drug advice is swapped.

The benefits of Ritalin and Adderall, which are meant to be used to treat ADHD, are compared with Provigil, Modalert and a group of drugs called ampakines – prescription pharmaceuticals that are showing promise in the treatment of Alzheimer’s and Parkinson’s.

The problem in telling students not to take them is that tests have shown these drugs can help with focus, memory, concentration and alertness by interacting in different ways with neurotransmitters – chemical messengers – in the brain.

the ADHD treatments contain amphetamines, which can result in addiction, and there are suspicions that sleep disorder treatments such as modafinil could be addictive.

Barbara Sahakian, Professor of Clinical Neuropsychology at Cambridge University, says scientists understand how drugs such as Ritalin work by stimulating levels of the neurotransmitters dopamine and noradrenaline in the brain.

These affect mood, cognition and memory. ‘However, there is an optimal dose for ideal performance,’ she says.

‘Levels beyond that could cause problems with addiction. With modafinil, no one really knows how exactly the drug acts in the brain to boost cognition.’

However, evidence is emerging that modafinil – thought not to be addictive – also affects the levels of dopamine. This is significant because dopamine production can lead to addictive behaviour.

Sometimes referred to as the ‘reward’ drug, dopamine is released during experiences such as the enjoyment of sex, food and drugs. We are programmed to repeat rewarding experiences, a cycle that can result in addiction.

A study published in the Journal of the American Medical Association last year looked at ten healthy men taking modafinil and found it did increase levels of dopamine. The research was conducted by the National Institute on Drug Abuse (Nida) in the U.S.

‘[Modafinil] has the signature that it could potentially be addictive,’ says Nida’s director Dr Nora Volkow.

‘Studies have shown consistently that all of the drugs of abuse . . . have a common effect of increasing dopamine in the nucleus accumbens [area of the brain].

‘That is believed to be crucial for their reinforcing effect and ultimately their underlying potential for producing addiction.’

The jury is still out on whether modafinil is addictive. Scientists regard tests on just ten people as being far from definitive.

Sahakian has called on the Government to hold a public debate on the use of smart drugs.

On the one hand, she feels they could be of real benefit to society if proven to be safe.

On the other, she wonders whether in some dystopian future people will be pressured into taking them to work longer and harder.

Already, there is evidence that students feel pressured into taking smart drugs to compete with highachieving classmates who are using them. And some pushy parents appear to be condoning their use.

One third-year student studying computer science at London Metropolitan University told us that taking modafinil is a ‘lifesaver’ in helping him to complete assignments.

‘I am aware of school children who have taken modafinil. They were aged between 16 and 18,’ he says.

‘Their father [a computer programmer], my friend, used to take it occasionally.

‘The parents had extremely high expectations for their children and they were taking exams.

‘My friend’s daughter was advised to take modafinil by her classmates. Unfortunately, this was a terrible decision.

‘She was taken to hospital after five days of sleep deprivation. She had high blood pressure, was anxious and experienced some kind of hallucinations and psychosis.

‘She was taking extremely high doses of modafinil. I was told she had felt some kind of euphoria and kept taking more and more. It is proof that modafinil can be addictive for some people.’

If Nida in the U.S. is correct and all these drugs affect dopamine levels in some way, then concern is likely to focus on students self-medicating inappropriate dosages and using them over a long time.

Dr Daniel Amen, a psychiatrist and Fellow of the American Psychiatric Association, says that while treating young ADHD patients with carefully controlled doses of Ritalin can improve their lives immeasurably, unmonitored doses taken by healthy youngsters could be damaging.

‘A therapeutic dose arrived at by careful monitoring by a physician might be anywhere from 5mg to 60mg a day,’ he says.

‘We know that can enhance brain function in many people by stimulating levels of dopamine.

‘But where you have some of these students taking concentrations of 100mg to 500mg, that could cause some problems.

‘The extra dopamine produced constricts blood flow to the brain and, over the long term, that could cause permanent damage.

‘The adolescent brain, especially the pre-frontal cortex – the most thoughtful part of the brain  -  is developing rapidly. Anything that disrupts or interferes with this process can cause lasting problems.’

There is debate on student forums over whether using smart drugs amounts to cheating.

Some say it does, while others argue that those who want to ban them should be prepared to give up commonplace stimulants, such as caffeine and nicotine. Even academics are divided.

Dr Anders Sandberg, a philosophy lecturer specialising in bioethics at Oxford University, tried modafinil as part of his research three years ago and now uses it openly.

In common with students who take it, Dr Sandberg is on the legal side of an illegal transaction. Under the 1963 Medicines Act, it is an offence to supply a drug without a prescription, but not to buy one.

‘When I take it, it is like having a little electric motor in the back of my head running through lists of things I need to do,’ he says. ‘Then, instead of putting them off until tomorrow, I go ahead and do them.

‘I use the drugs only occasionally if I have a paper to write or need to fly long distances to attend a conference or deliver a speech. I find that instead of having jet-lag, I can focus on the job at hand.’

But isn’t that sending the wrong message to students?

‘This is something I have spent a lot of time considering, but in general I believe people should have control over their own bodies,’ he says.

‘That right is important, but you need to use it appropriately and that’s why youngsters shouldn’t take responsibility for managing drugs, alcohol or enhancers. ‘These drugs are like step-ladders.

‘If you need them to attain something that would otherwise be out of your reach, then use them. But if you can reach those heights anyway, then you’re just being lazy.’

However, health professionals take a dim view of anyone misusing drugs.

‘Anyone taking prescription drugs without a prescription obtained through a consultation with a health professional is making a big mistake,’ says Neal Patel, a pharmacist and spokesman for the Royal Pharmaceutical Society.

‘It’s dangerous to experiment with medicines and the sideeffects of cognitive enhancement drugs are significant  -  they can cause abdominal pain, nausea, heart problems and changes in blood pressure.

‘These side- effects are dose dependent  -  the more you take, the greater your risk of being affected and seriously harmed.’

Professor Sahakian and Dr Amen say there are other, less risky yet proven remedies for improving brain function: like sleep, exercise and a healthy diet for instance. Apparently, they work.

First published in the Daily Mail

http://www.dailymail.co.uk

Indeed shifting patients from a soon-to-go-off-patent blockbuster, to its tweaked successor is old hat in the pharma biz.

Ever since drugmakers figured out that adding a time-release coating or other slight improvement could earn it a new round of patent protection, they’ve been developing strategies for competing against their own meds.

Raising the price of the old version to get patients to switch to the new brand, hoping they’ll stick when the old one goes generic? Done.

Touting the slight improvement as if it’s a major advance? Also done.

If you’re interested just what Cephalon might bring to its follow-up party, check out its Q2 earnings call. Jim Edwards at BNET Pharma did, and found that it’s eyeing new indications–and a new focus on recently won indications–as a Nuvigil switching strategy. According to the call transcript, it’s also using price breaks: free samples, a seven-days-free coupon, co-pay assistance of up to $50 per scrip. It’s offering deals to insurance plans and managed care companies. All to capture brand business before the wakefulness med Provigil goes off patent, sometime before 2012.

But more about those new indications. At the end of June, Cephalon asked FDA to approve Nuvigil for jet lag disorder. It’s studying Nuvigil as a treatment for sleepy brain-injury patients. It’s plotting two Phase III trials of Nuvigil as an add-on for bipolar depression. It’s enrolling for a IIB study in schizophrenia. And it’s in the early stages of developing Nuvigil as a treatment for chemotherapy-related fatigue.

That’s quite a range of uses. And at least in the case of jet lag disorder, one might argue–as BNET does in relation to Nuvigil’s shift-work fatigue indication–that jet lag is a natural physical response that Type A business travelers hate. And those travelers would be quick to ask for Nuvigil even if their jet lag isn’t extreme enough to be disorderly. That’s all good for Nuvigil sales, of course. And Provigil and Nuvigil together account for half of Cephalon’s recent revenues. Stay tuned.

Looking for generic versions of Provigil/Modafinil? Your quest is over. Buy generic provigil HERE.

http://www.fiercepharma.com

It was originally designed for narcoleptics, but clinical trials stumbled across something odd: if you give it to non-narcoleptics, they become smarter. Their memory and concentration improves considerably, and so does their IQ. There were no known side-effects, except – oh, thank you! – weight loss.

I hunted it down online. A week later, the little white pills arrived in the post. Within a few hours of a 200mg dose, I found myself gliding into a state of long, deep concentration, able to read a book for six or seven hours at a time without looking up. My mood wasn’t any different; I wasn’t high. It was like I had opened a window in my brain and all the stuffy air had seeped out, to be replaced by a calm breeze. On Provigil, I had the most productive month of my life, writing reams of articles. I didn’t notice any side-effects – until the third week.

At any given time, only a small amount of your brainpower is dedicated to the tasks immediately in front of you. The rest is working on other stuff – processing memories, your subconscious, your creative thoughts. But Provigil points all your mental guns forward. It deploys far more of your brainpower on to your direct task.

It’s great at first – but it has a cost. After a while, you realise that your mental life is oddly depleted. Creative thoughts don’t come to you any more. You are running on the imaginative store you built up before Provigil, and whizzing through it efficiently, but you aren’t inventing anything new. That part of your brain is undernourished. You feel fast and flat.

When I stopped taking them, my brain went back to its slower, scrappier state – but my creative impulses came back. I was more spontaneous again. So I have cut a deal with myself. I keep a pack in the bathroom cabinet for the days when I am really knackered and have to be able to work fast and fluently – but I don’t ever take more than one or two a month.

But if I ever had to do exams again, I would take Provigil. And here’s the ethical dilemma. Is this the equivalent of athletes taking steroids? Does it create an unfair pressure for other people to take these drugs – which are still pretty expensive – to keep up with other students and co-workers? Or would we be unfairly holding the human race back by refusing to smarten up?

We can’t escape these dilemmas now. Smart drugs are only going to become more subtle and powerful as money flows in. As Professor Anjan Chatterjee says: “This age of cosmetic neurology is coming, and we need to know it’s coming.” My little pack of Provigil is a challenge to us all.

http://www.independent.co.uk

Frequent travelers know that one of the biggest annoyances they have to face each time they land is jet lag.

Until not long ago, it was believed that jet lag was nothing more than just an upsetting occurrence that no one could do anything about, other than bear with it until it went away.

Since research has shown that it’s actually a disorder, Cephalon has already come up with a cure for it in the form of Nuvigil, which is poised to become the first drug for jet lag.

“The efficacy and safety of Nuvigil as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years.

Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility.

Clinical efficacy was evaluated using two primary endpoints: an objective assessment – the Multiple Sleep Latency Test (MSLT), and a subjective assessment – the Patient Global Impression of Severity (PGI-S).” a statement from the company says.

At the same time, the statement adds that the exact, detailed results of the study have not yet been submitted for presentation.

Yet, the initial numbers indicate that Nuvigil could be effectively used to treat jet lag in all sufferers, which would virtually put an end to this acute, circadian rhythm sleep disorder, as Cephalon classifies it.

Next up on the company’s to-do list is submitting the drug for approval with the FDA, after wrapping up the studies and drawing the line as to its efficiency with jet lag symptoms.

However, as Goldman Sachs analyst Shibani Malhotra wrote in a note to investors, getting this approval for jet lag would mean Cephalon would be able to market Nuvigil to a broad range of doctors, which, in turn, might make “this indication be viewed as ‘lifestyle’ (less severe) and would enable use of the drug in a broader population.”

Cephalon spokeswoman Candace Steele is optimistic that Nuvigil will get approval for jet lag, since this is not a condition that should be disregarded just because it goes away, as she tells in a statement to the Health Blog.

“We do acknowledge that this is an acute condition that does resolve itself once someone does adjust to a local time zone. [Still,] there is a functional impairment for people who have jet lag disorder.” Steele underlines.

If all goes according to plan, Cephalon intends to start marketing Nuvigil for jet-lag use in the latter part of 2009.

http://news.softpedia.com

The drug, called Nuvigil, is licensed in some countries, such as the U.S., to help shift-workers keep alert through the night.

Now the results of a new clinical trial suggest it could also be beneficial for passengers coping with the exhausting effects of long-distance flights.

Tests on more than 400 volunteers who flew from the U.S. to France showed those who took one pill shortly before boarding the plane were considerably less drowsy and more alert on arrival than those who did not.

The U.S. company that makes the drug is applying for permission to market it as the world’s first jet lag pill.

If successful, it could be on sale in the U.S. and Europe by the end of this year or early 2010.

Jet lag is a common condition that usually occurs only when flying long distances. As the body crosses different time zones, its circadian rhythm – or internal biological clock – becomes disrupted.

This is the mechanism that tells you when to sleep and when to wake up.

The circadian system also affects hunger, digestion, urine production, body temperature and blood pressure.

For example, it is normally in tune with local time, so we feel hungry in the morning and sleepy at night. Major time changes upset this rhythm, often leaving travellers sleepy in the day and wide awake at night.

It’s not clear why, but jet lag is more common in those over 50; children and babies rarely suffer from it.

Sleep experts say the worst of the symptoms can be avoided by taking simple measures, such as adjusting your sleeping routine a few days before travelling. If travelling east, it’s best to go to bed an hour earlier than usual. If west, make it an hour later.

Other measures include spending as much time outdoors as possible on arrival. Natural sunlight helps the body adjust to its new routine.

But a quick fix has obvious appeal. U.S. pharmacies already sell melatonin, a pill based on the body’s sleep-regulating hormone. But the drug is not licensed for sale in Britain.

The latest remedy, however, is based on Provigil, a medicine approved for use in this country for the treatment of narcolepsy, the condition that triggers frequent bouts of daytime sleep.

It works by stimulating activity in the central nervous system – in other words, the brain and spinal cord. Exactly how it increases wakefulness is not fully understood.

Nuvigil, from Cephalon Inc of Pennsylvania, is a longacting form of this drug and is designed to help those who need to stay awake for longer.

Researchers recruited 427 travellers who complained of severe jet lag in the past.

Half were given 150 milligrammes of Nuvigil to take shortly before boardinga transatlantic flight.

On arrival, all the travellers were given tests to measure their drowsiness.

The results, which have yet to be published in a medical journal, showed those on the jet lag pill suffered significantly fewer symptoms.

However, some reported side-effects included headaches, anxiety, nausea and heart palpitations.

Sleep expert Dr Neil Stanley, from Norfolk and Norwich University Hospital, said he was concerned the drug would help to medicalise a normal reaction to time change.

‘Jet lag is not an illness, it’s simply a consequence of long-distance travel,’ he says.

‘You get jet lag because it’s light or dark when, as far as your body is concerned, it should not be.

‘Now it seems it is being treated as a reason to take medicine. I can understand someone on a business trip wanting to feel their best when they arrive. But you could probably get the same effect by drinking coffee or going out in daylight.

‘It takes only four minutes of exposure to sunlight to tell your body clock that it’s daytime.’

http://www.dailymail.co.uk

Cephalon made the announcement after releasing positive results from a Phase III clinical study of the drug for that indication. Nuvigil is already on the market to treat sleepiness associated with narcolepsy, sleep apnea and night shift work.

http://www.marketwatch.com

The drug is already approved to treat several sleep disorders and is an updated version of Provigil, which also treats sleep disorders.

Cephalon said Nuvigil met its goal in a late-stage study focusing on excessive sleepiness associated with jet lag.

The company is also studying Nuvigil as a potential treatment for bipolar disorder.

http://news.moneycentral.msn.com