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Thread: Provigil?

  1. #1
    SecretNY's Avatar
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    Provigil?

    My wife is a doctor and asked me if I knew anyone in LE who has taken Provigil (modafinil) to stay alert and awake. She says that the pilots in the Air Force use it. I search the web on it and came across this article. DMClark or ATFSAC? You guys hear of this?

    Thanks,
    SecretNY


    A Pill to Stretch Your Day
    A new drug keeps people awake with no apparent ill effects. But is prescribing it the right thing to do?
    By TIMOTHY GOWER
    Special to The Times

    April 15 2002

    It has become a modern cliché: There aren't enough hours in the day. Americans are struggling to balance work and family commitments while trying to find time for a social life and recreation. A growing number of supermarkets, restaurants, gyms and other businesses are accommodating today's 24/7 culture by staying open all night. Not to mention, of course, that the Internet never shuts down. But what if you could do the same?

    What if you could take a pill and stretch your day--by skipping sleep?

    That sounds like the stuff of science fiction, but a drug called Provigil could make it possible. Studies have shown that this new medication allows people to remain awake and attentive when their bodies normally crave shut-eye, without suffering the unpleasant side effects and risk of addiction associated with caffeine, amphetamines and other stimulants.

    Researchers caution that the long-term health consequences of avoiding slumber by taking Provigil, or any drug, aren't well understood.

    And the makers of Provigil go out of their way to state that the drug is strictly for patients who feel sleepy during the day due to diagnosed medical disorders. Yet as its reputation grows, doctors may soon find themselves faced with a difficult question: When is sleepiness a sickness?

    "This drug is going to bring up some very interesting ethical dilemmas," says Dr. Mark Mahowald, director of the Minnesota Regional Sleep Disorders Center in Minneapolis and an expert on the causes of daytime sleepiness. "Do you prescribe a stimulant medication for someone who is intentionally sleep deprived?"

    Currently the U.S. Food and Drug Administration has approved Provigil only for the treatment of one condition, narcolepsy, which causes a sudden and uncontrollable urge to sleep. But Cephalon, the West Chester, Pa.-based company that sells Provigil, hopes to win FDA approval within a few years to market the drug as a pick-me-up for people plagued by sleepiness associated with any medical condition. Many doctors in this country already prescribe Provigil "off-label," that is, for conditions not approved by the FDA (which is a common and perfectly legal practice). Those conditions include depression, sleep apnea, Parkinson's disease and multiple sclerosis.

    What's more, scientists at sleep clinics across the United States are studying whether Provigil can help those working the swing or graveyard shift, who are sometimes diagnosed with a condition known as "shift work disorder." Symptoms can include insomnia, headaches and an all-around blah feeling, in addition to problems staying focused on the job.

    For 20 years, Jane Jaegers has worked the overnight shift as a 911 dispatcher for Santa Clara County--four days a week, 9 p.m. to 7 a.m. The San Jose resident loves the job, but her body has never adjusted to the odd schedule. In the wee hours of the morning, Jaegers says, her attention occasionally drifts during nonemergency calls. If she takes them in time, caffeine pills such as Vivarin and No-Doz help, but they leave Jaegers staring at the ceiling when she goes home and crawls into bed. Constantly exhausted, she has seen her social life suffer. Go to a movie? "As soon as the theater gets dark, I'm gone," says Jaegers, 55.

    In December, Jaegers heard that scientists at the Sleep Disorders Clinic at Stanford University were studying Provigil, whose name is shorthand for "promotes vigilance." She signed up right away.

    Every night before leaving for work, Jaegers takes two small tablets--she calls them "magic pills." Because half the people participating in the study are receiving placebo tablets, Jaegers can't be sure she's popping Provigil. But she thinks her pills are the real deal. "I just feel more alert," says Jaegers, who adds that she sleeps soundly these days too. "I'm tickled with the stuff."

    Drug Is Not Classified as a Stimulant

    Provigil was developed in France in the 1970s. Although no one is sure how it works, animal studies show that the medication--unlike other drugs that induce wakefulness--doesn't seem to dramatically increase levels of dopamine, a neurotransmitter associated with arousal and alertness.

    Caffeine and older prescription stimulants buzz the entire central nervous system, causing jitteriness, insomnia and other unwanted effects. When people who use coffee or amphetamines to stay awake finally doze off, they often remain in bed for much longer than usual, their bodies paralyzed by the need for "rebound sleep." Provigil, meanwhile, seems to target only the part of the brain that keeps us awake. When its effects wear off, the user resumes a normal sleep pattern.

    "Provigil isn't considered a stimulant per se, though it has a wakefulness effect," says Dr. Jed Black, director of the Stanford Sleep Disorders Clinic, who is involved in the shift-work study. Although Black says Provigil isn't effective for all patients, it helps many people haunted by daytime sleepiness keep on their toes. While a few users report mild nausea, most don't feel a thing other than awake and alert. When patients switch from older stimulants to Provigil, says Black, they often return to his office and say, "It's not working. I don't feel revved up." Yet tests usually show that their ability to stay awake is much improved.

    Earlier research found that when healthy people take Provigil they are able to stay awake and on the ball for a long, long time. For example, a 1995 Canadian study showed that subjects taking the drug were able to perform well on cognitive tests while remaining awake and in good spirits for two and a half days. In another study, published in 2000, U.S. Army helicopter pilots stayed awake for 40 hours while being called upon periodically to perform maneuvers on a flight simulator. Unmedicated, the aviators became sloppy and made errors in the early morning hours. But while taking Provigil during a second 40-hour marathon, their skills and focus never wavered.

    Army psychologist John Caldwell, who conducted the latter study, says more research is needed to determine whether dosing soldiers with Provigil is a safe and effective way to promote alertness. However, he says, it's possible that one day the drug could be used "as an emergency measure to briefly overcome fatigue in 'must-do' missions where total sleep deprivation is unavoidable."

    What About Students and Working Parents?

    But aren't many of us faced with our own "must-do missions" from time to time? If Provigil works for soldiers and pilots, won't it do the same for college students cramming for exams? Medical students on 36-hour rotations? Or a working parent with a sick child and a presentation to finish for tomorrow's big meeting with potential investors?

    Cephalon spokesman Robert Grupp emphasizes that Cephalon has no plans to market Provigil to the all-nighter crowd. "It's not for people who work too long," he says. "It's for people with clinical illness." But as word spreads of Provigil's powers, it seems inevitable that the healthy-but-harried will be intrigued.

    "Silicon Valley will go wild over this thing," says Andy Serwer, a columnist for Fortune magazine who admits to burning a fair amount of midnight oil when he's on deadline. Instead of swigging Jolt cola and espresso, software designers under the gun could simply take Provigil, which costs about $4 per pill--not much more than the price of a double latte.

    But would executives pressure their employees to take a pill for the team? Possibly, says Serwer, if they heard that workers at other firms were pulling Provigil-fueled all-nighters. "You would be at a competitive disadvantage if you didn't," he says.

    If any doctors have begun prescribing Provigil to college students and corporate workers under the gun, they're keeping the practice quiet. But Provigil does raise a difficult question for the medical community. What if people who work in positions where sleepiness can endanger themselves and others start asking their doctors for the drug?

    Shift Workers Pose Dilemma for Doctors

    Take long-haul truckers, for instance. According to federal regulations, they're supposed to take breaks every 10 hours. But many drivers ignore the law, even if it means navigating an 18-wheeler while bleary-eyed. A recent exposé by the Milwaukee Journal Sentinel featured an interview with one driver who admitted to being behind the wheel of his big rig for 36 straight hours.

    "Do you give that person the medication to keep him awake and not kill himself and a car full of people?" asks Mahowald, of the Minnesota Regional Sleep Disorders Center. "Or do you as a matter of principle say, 'No, you cannot have this medication because you don't have the proper sleep disorder'? ... Quite frankly, in the interest of public safety, I would be tempted to give the individual stimulant medication."

    Not all sleep experts feel that's the right choice. "I think that becomes irresponsible," says Black. "There might be fewer accidents on our highways, but there might also be long-term health consequences" associated with using Provigil "that we aren't anticipating." Black says he will only prescribe the drug to people whose sleepiness and fatigue are caused by a medical condition or occur as a side effect from another medication. However, Black, Mahowald and other sleep researchers agree that it's unwise to think Provigil or any pill will make shut-eye optional.

    "We don't understand the role sleep plays," says the Army's Caldwell. "It's a bad idea for anyone to rely on a drug of any description to maintain alertness."

    And yet for Jane Jaegers and other shift workers, Provigil may mean the difference between a zombie-like existence and a normal life. And they represent a huge potential market for Cephalon. The number of shift workers in the United States increases 2% to 3% each year, says David Mitchell, a spokesman for Circadian Technologies, a Lexington, Mass., company that advises firms that want to convert to 24/7 operation.

    The nationwide shift-work study should be completed by the end of this year. If the results are promising, perhaps Provigil will one day be found in the medicine cabinets of police officers, firefighters, nurses and other people who work nights. And if that happens, what's to stop the son of a shift worker from asking, "Hey, Dad, I've got a history final on Tuesday--can I bum a Provigil?"

    Then again, maybe Junior won't bother asking--the medication is on sale through Internet-based pharmacies based overseas, often marketed as a "smart drug."

    In "Faster: The Acceleration of Just About Everything" (Vintage, 2000), author James Gleick writes about our changing notion of time. Reached by e-mail, he was dubious about using a drug to lengthen our days. "In a time-obsessed age, this is the Holy Grail," said Gleick. "Cheating sleep is the closest thing we have to cheating death." However, until scientists better understand the phenomenon known as sleep, he was quick to add, "Beware of miracles."
    If you want other stories on this topic, search the Archives at latimes.com/archives. For information about reprinting this article, go to www.lats.com/rights.


    Copyright 2002 Los Angeles Times
    "Certainly there is no hunting like the hunting of man and those who have hunted armed men long enough and liked it, never really care for anything else thereafter."
    ---Hemingway

  2. #2
    ATF SAC's Avatar
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    Haven't heard of it particularly. Coffee, naps, adrenaline and fear work pretty well for me. As DMClark and I have matured, so does a shrunken bladder. For an applicant, as a scrip drug, better have a scrip otherwise you go south as a user of illegal drugs and if you have a scrip, better get it disclosed in the medical so our med review folks can decide on its impact or whether the condition that requires it prevents you from performing the duties of the position.

    If its important enough, you can go a long time without enough rest. Trick is to get down when you can. Problem with "sleep" replacing anything, including some well know illicit pharmacuticals, is in the slightly longer route to the drug burning your brains out, lack of real sleep will put you into a hallucinatory, bad judgement, bad reaction place.

    You get to a personal predjudice with this info: Mother's Little Helper, the all natural pick me up or bring me down just right for the modern American lifestyle. Oh Grow UP, everybody! If you have narcolepsy this stuff is for you, but if you have it you are not going to be an agent anyway. The rest of you, stop boogieing and get some sleep.

    Lastly, DM will back me on this I believe (or correct me if need be) Heroin was introduced into the United States as the miracle, non addictive cure for the poor wounded soldiers who became morphine addicts during the Civil War. Methadone, the great harmless cure for Heroin addiction, whoops.

    Interesting stuff, tell your wife, but looks to me like big trouble for moose and squirrel if caught using it on duty.
    ret.

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    Provigil or generically METHYLPHENIDATE is a Schedule II drug under the Controlled Substances Act, therefore has been determined to have a high potential for abuse. Note the info from DEA at present:


    Methylphenidate

    Methylphenidate, a Schedule II substance, has a high potential for abuse and produces many of the same effects as cocaine or the amphetamines. The abuse of this substance has been documented among narcotic addicts who dissolve the tablets in water and inject the mixture. Complications arising from this practice are common due to the insoluble fillers used in the tablets. When injected, these materials block small blood vessels, causing serious damage to the lungs and retina of the eye. Binge use, psychotic episodes, cardiovascular complications, and severe psychological addiction have all been associated with methylphenidate abuse.

    Methylphenidate is used legitimately in the treatment of excessive daytime sleepiness associated with narcolepsy, as is the newly marketed Schedule IV stimulant, modafinil (Provigil®). However; the primary legitimate medical use of methylphenidate (Ritalin®, Methylin®, Concerta®) is to treat attention deficit hyperactivity disorder (ADHD) in children. The increased use of this substance for the treatment of ADHD has paralleled an increase in its abuse among adolescents and young adults who crush these tablets and snort the powder to get high.

    I don't think you'll see this in LE circles to make it through the shift. Coffee is still the only approved stimulus authorized for general LE use!
    “Life should not be a journey to the grave with the intention of arriving safely in a pretty and well preserved body, but rather to skid in broadside in a cloud of smoke, thoroughly used up, totally worn out, and loudly proclaiming "Wow! What a Ride!”
    ― Hunter S. Thompson

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    SecretNY's Avatar
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    dm,

    I asked her on that and then checked the DEA site on it (as well as a pharm site). METHYLPHENIDATE is sched. II but MONAFILIN (Provigil) is classified sched. IV.

    PROVIGIL is a Schedule IV drug. Schedule IV drugs, as a class, have lower abuse potential than Schedule II or III drugs. Many of the drugs currently used to treat narcolepsy, such as amphetamines (for example, Dexedrine) and methylphenidate (Ritalin),* are Schedule II drugs. (from the pharm)



    Modafinil (Provigil®)

    Modafinil is a central nervous system stimulant that is being considered for approval by the FDA, under the trade name Provigil®. Modafinil is being considered for marketing as a prescription drug product for the treatment of excessive daytime sleepiness associated with narcolepsy. Modafinil produces many of the same pharmacological effects and adverse reactions as classic psychomotor stimulants, but appears to have chemical properties that may limit its abuse (i.e., not water soluble, decomposes in heat). DEA is unaware of any reports of modafinil abuse. On December 22, 1997, FDA sent DEA their scientific and medical evaluation of modafinil and a recommendation that modafinil be placed in Schedule IV of the CSA. Subsequent correspondence from the FDA dated February 24, 1998, confirmed that FDA continues to evaluate the pending New Drug Application (NDA) for modafinil. FDA has determined that the NDA is "approvable" and has issued an approvable letter to the NDA sponsor. According to the February 24, 1998 letter from FDA, "upon full approval of the NDA, modafinil 'will have a currently accepted medical use in the United States.'" DEA completed its review and determined that modafinil, including its salts, isomers and salts of isomers, warrant control in Schedule IV to the CSA, if and when the modafinil NDA is approved by the FDA. A proposed rule to place modafinil and its salts and optical isomers in Schedule IV was published in the Federal Register on April 14, 1998. As stated in the Federal Register proposal, the scheduling of modafinil was not to be finalized until the NDA for modafinil was approved by the FDA. On December 30, 1998, the FDA notified the DEA that the modafinil NDA was approved by the FDA on December 24, 1998. On January 20, 1999, DEA signed its Final Rule placing modafinil in CIV and sent it to the Federal Register. The Final Rule placing modafinil in Schedule IV was published in the Federal Register on January 27, 1999.

    For questions and comments regarding drugs mentioned in these articles, please contact:

    The Drug and Chemical Evaluation Section of the Drug Enforcement Administration at 202-307-7183.

    I agree on the coffee (if only Starbucks was open 24/7 with a drive thru). Since it's IV do you think more people will use it?

    Thanks
    SecretNY
    "Certainly there is no hunting like the hunting of man and those who have hunted armed men long enough and liked it, never really care for anything else thereafter."
    ---Hemingway

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    ATF SAC's Avatar
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    As I noted earlier, we American's love Mother's Little Helper so I bet its got abuse potential galore. I'm a Starbucks man myself, but on the really long ones, in the wee hours, nothing like the stop and rob cup that's been there longer than every employee currently working at the place has had a job. Not enough Cremora in the world to soften it.
    ret.

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    Narcoleptics aside, who in the world would want to stay up longer? I love sleeping , no really. I get enough sleep that I can stay up late whenever I really NEED to (like cramming for finals in college) (or that shock of realizing that I forgot to print my transcripts for my TEA in the morning, its 12:30am now...and my printer's black ink head is busted....)

    Anyone else think its funny that we have drugs to counter drugs, to counter drugs?

    Just enjoying my Friday,

    Ted

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    Whatever shcedule the drug is does not make a difference in my book, I am a Drug Recognition Expert and will tell you that all schedule drugs have an effect on you whether it is noticeable or not.

    All a schedule mean is the potency of the drug and its addictability, the fact that Modafinil (Provigil®) is a schedule IV drug now and the main component is a shcedule II means that some doctors and scientisits changed the chemical make up of the drug to allow for a lessor dosage or a counteracting agent to allow for a lesser action cerated by the original drug and convinced the FDA of the lessor potential of abuse.

    Cause of course codeine is a derivative of opium and percadan(sp) is an synthetic analog of codeine and percaset is precadan with aspirin added to it. All of the drugs have basically the same effect just may take more of it.

    They have the same potential for abuse.

    Some drugs are abused less due to the fact that they take more of the item to get the high, but if someone is desperate they will use whatever they can get.

    Raven231

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    Thanks for the Scheduling info. The DEA site really makes one thing that Provigil is a Schedule II, rather than a IV. However, whatever schedule, it would have to be legally prescribed by a doctor for anyone to use. Abuse is a totally different story...

    ALL Schedules are currently abused and from a legal standpoint, if an officer had a reason to have a Provigil prescription, then he/she would have no issues on a drug screen. However, the department may have issues with drug useage merely to stay awake.
    “Life should not be a journey to the grave with the intention of arriving safely in a pretty and well preserved body, but rather to skid in broadside in a cloud of smoke, thoroughly used up, totally worn out, and loudly proclaiming "Wow! What a Ride!”
    ― Hunter S. Thompson

  9. #9
    slappy Guest
    I'm with universible. I likes my sleep. I needs my sleep. I gots to has my sleep. Seriously...

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    SecretNY's Avatar
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    Originally posted by ATF SAC
    As I noted earlier, we American's love Mother's Little Helper so I bet its got abuse potential galore. I'm a Starbucks man myself, but on the really long ones, in the wee hours, nothing like the stop and rob cup that's been there longer than every employee currently working at the place has had a job. Not enough Cremora in the world to soften it.
    ATF, I thought at 33 I knew a lot, but I'm pretty clueless as to what Mother's Little Helper is (I always was told I was )

    And wasn't Cremora the scary virus they were after in Mission Impossible II?

    Thanks!
    "Certainly there is no hunting like the hunting of man and those who have hunted armed men long enough and liked it, never really care for anything else thereafter."
    ---Hemingway

  11. #11
    NYC03 Guest
    " Mothers Little Helper " is a reference from a Rollings Stones song about a "little yellow pill" "She'll go running for the shelter of your mother's little helper.---- sister please some more of these outside the door she took four more too get her through her busy day" I think that is how it goes.

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    If my wife has another kid, I'm definitely going to get me some of this stuff.

    All kidding aside, I have to agree with ATF SAC on something. When it's important, you'll stay awake. In several previous lives (US Army and GBI) I found myself going strong for days on little or no sleep. However, no one crashes like I do when it's time to stand down. My wife says I could sleep through someone dynamiting the house.

    BUT...those nights of early parenthood were a challenge. I never knew how much I could accomplish with 15 minutes of sleep between feedings.

    ATF SAC: my mom gave me an Aladins Stanley Steel Thermos when I left for the Army. Still got it. It's served me well for over 15 years. I fill 'er up and take it with me for those mornings when we start early. Beats $3.50 a cup at Starbucks.


    28:1 The wicked flee when no man pursueth: but the righteous are bold as a lion.

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    All's I know is that I got through college on hardly any sleep. I worked 25-30 hours a week (not as much as most people I knew at the time, mind you)..and although I was a music major, I actually had morning classes all 5 years. That's saying a lot, since most people thought we just showed up at 3pm for rehearsals....and even then, late.

    I know I can get through just about anything with no sleep. Though I usually ask my wife to drive on real long late night trips...I have dosed off once or twice and scared the crap out of myself (once was behind the wheel of a street sweeper...oh, college jobs....). I just hate taking medication. I have had numorous surgeries in the past, and had grown a little too fond of the demeral (sp)...my mom caught me sneaking it and ended up throwing it away. Ever since then I've made a point to only take medication that the doctors absolutely insist I take....even stay away from antibiotics when I can.

    I think we have too many pills....but I ramble...

    Ted

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    ATF SAC's Avatar
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    I will try to work more Matchbox 20 references into my posts, thanks NYC03 for the catch- and right to the point I was referencing.

    Ah Mac, still a decent cup, my friend. It's the sour old station house brew y'need. Plenty of heartburn and a sense that the trots will get you if you doze off that keeps a cop going. Cremora or cream, it sits curdled and undissolved on the top like a Bizarro latte. (Bizzaro is a '50's Superman reference, you get some culture reference along with the bad advice I give).

    Am reading a Bourne novel in the series, picked them up after the movie. Great line in it for this, "Rest is a weapon."
    ret.

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    SecretNY's Avatar
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    ATF, you're right, Ludlum has a way with words (if only Matt Damon did).

    Wouldn't Cremora be Aromerc in the Bizzaro world?

    Take care,
    SecretNY
    "Certainly there is no hunting like the hunting of man and those who have hunted armed men long enough and liked it, never really care for anything else thereafter."
    ---Hemingway


 
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