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Hormone containing nasal spray could one day replace coffee as morning pick me up

Millions of people across America battle daytime sleepiness. Whether due to a sleeping disorder or not having enough time in the day, few get the recommended eight hours of sleep each night.

A group of DARPA-funded scientists have developed a new nasal spray that could replace your morning coffee as a pick me up. Wired reports that the scientists say the nasal spray containing a hormone called orexin A is a promising candidate for sleep replacement therapy and likely treatment for the sleep disorder narcolepsy. Another study found that low levels of orexin A in the brain could be the main cause behind narcolepsy.

Dr. Jerome Siegel told Wired that orexin A is, “a totally new route for increasing arousal, and the new study shows it to be relatively benign.” Unlike other stimulants used to combat sleepiness from common caffeine containing drinks like sodas and coffee to drugs like amphetamines, the nasal inhalation spray containing orexin A reduces the feeling of sleepiness without causing users to be on edge.

The U.S. Military deems the discovery as a safer way to keep troops alert. The military funded research into the stimulant modafinil, also known as Provigil, to help troops stay awake and alert. DailyTech reported last week that Provigil is one of the new drugs being used as a sort of mental steroid to help keep users focused. One user of Provigil, a professional poker player, credits the drug with helping him win millions in prize money playing poker by allowing him to be more alert and concentrate better.

Currently the nasal spray is in animal testing. Researchers claim when used on 30 to 36 hour sleep-deprived monkeys the subjects perform as well on cognitive tests as monkeys who aren’t sleep deprived. A set of control monkeys was treated with a saline placebo and found to be severely impaired in the same cognitive tests.

Dr. Michael Twery, director of the National Center on Sleep Disorders Research told Wired research into drugs for sleepiness is “very interesting.” However, Twery adds that the use of drugs to combat sleepiness may not alleviate other problems associated with sleep deprivation such as increased risk of metabolic disorders and cardiovascular disease.

Dr. Siegel says that, “…you'd have to be a fool to advocate taking this [orexin A] and reducing sleep as much as possible."



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Nose Candy Anyone?
By littlebitstrouds on 12/31/2007 11:12:44 AM , Rating: 2
There's something a little "dirty" about snorting something for energy. Can't we come up with a better way of ingesting this? Like maybe as a sweetener in my coffee? Mmm hormone creamer.




RE: Nose Candy Anyone?
By kileil on 12/31/2007 11:23:27 AM , Rating: 3
quote:
Can't we come up with a better way of ingesting this?


During trials they found placebo suppositories woke up test subjects even better, but obviously they couldn't patent sugar pills.


RE: Nose Candy Anyone?
By afkrotch on 12/31/2007 11:31:35 AM , Rating: 1
Nasal spray. The suck. I drink coffee cause I enjoy the taste, as well as the caffeine.


RE: Nose Candy Anyone?
By Samus on 12/31/2007 12:45:04 PM , Rating: 2
I wake and bake every morning because I need a 'chill me out' rather than a 'pick me up.'

My system rejects such drugs as Codeine (any opioid for that matter), Ritalin (tried it to aid a sleeping disorder I had) and many other synthetic drugs.

Marijuana at night before bed and in the morning before eating has helped combat my mild narcoleptic problems. It's unfortunate that its street price is ridiculous these days, rivaling the price of synthetic drugs, even when you consider insurance coverage.


RE: Nose Candy Anyone?
By FITCamaro on 12/31/07, Rating: 0
RE: Nose Candy Anyone?
By monitorjbl on 12/31/2007 2:15:18 PM , Rating: 2
Not that I'm advocating doing that, but you'd be surprised how often that happens.


RE: Nose Candy Anyone?
By Fnoob on 12/31/2007 2:44:01 PM , Rating: 2
But it would be OK with you if his doctor prescribed him dronabinol?

You come off sounding just a wee-bit holier-than-thou.

I do know many professionals who have made the same choice and do very well.


RE: Nose Candy Anyone?
By JohnnyCNote on 12/31/2007 7:28:31 PM , Rating: 2
. . . you might try something that "professionals" do like research sleep disorders before making uninformed cheap shots. There's much about brain and neurochemistry in general that is not known.

Or is it just all in one's head?


RE: Nose Candy Anyone?
By MeTaedet on 12/31/2007 7:52:30 PM , Rating: 5
Yeah, because no one ever has experiences in life that differ from your own. Everyone faces precisely the same challenges in life of precisely the same difficulty level. No one has a different psychology or physiology; therefore, if they fail to be as awesomely drug-free and successful as you are, it's because they just aren't putting their back into it or don't have the discipline and mental fortitude that you have developed through grit, trial, and determination.

I have depression. Is that because I don't have the right attitude about things? I'm bisexual. Is that because I simply haven't tried hard enough to like women exclusively and am an indolent sort of person who isn't willing to put forth the necessary effort? (Not that I think homosexuality or bisexuality to be any sort of problem - or rather it's only a problem because officious and self-righteous piles of puke make it one.) I have sleeping problems; no matter how much I sleep - and I have tried everything from 6 to 12 hours a night - I feel extremely tired during the day, so much so that I can hardly keep my eyes open and I live a very unfulfilling life - and this, despite the fact that I exercise and try to eat right (I weigh 155 lbs at 5'11''). Because I am just not disciplined enough, right?

Let's not pretend that everyone can alleviate their problems in the same way you can. Grow the f**k up, you colossal a**hole.

And, I don't see, frankly, how drug use is such a great problem. There are health risks, but prohibition of drugs produces far greater and more serious problems. Maybe you can read the following and grow out of your worthless indoctrination at the hands of D.A.R.E. or whatever...

http://en.wikipedia.org/wiki/Arguments_for_and_aga...


RE: Nose Candy Anyone?
By Tiamat on 12/31/2007 2:57:40 PM , Rating: 2
I dunno if you are being serious, but Nasal Sprays are the most effective mechanism for delivering certain drugs - mostly ones that need to quickly cross the blood-brain barrier like nicotine and perhaps this drug. For these types of drugs, nasal drug delivery is more effective than intravenous because the later allows drugs to undergo some metabolism before crossing the blood-brain barrier.

Of course pill form is the least effective in terms of bioavailability for most drugs. Transdermal is restricted to certain drugs that can pass the skin and also has relatively low bioavailability.


there is already several drugs for this...
By NickWV on 12/31/2007 12:47:54 PM , Rating: 2
there is crack, caffeine and various other stimulants. I don't see the need for this.

As with the other drugs there are risks of use and overuse. I would like to know the side effects of this particular drug, I highly doubt there are none.

Adderall is the college students all night study buddy, I wonder if this would just end up being another way to keep people awake for days at the risk of their health.




RE: there is already several drugs for this...
By NickWV on 12/31/2007 12:51:57 PM , Rating: 2
adding to my post;

I think is ill advised to try to treat the symptoms of being sleep deprived and instead find a way to solve the problem. If there were a drug that enables a person to get more out of the time that is actually spent sleeping, wouldn't that be a better way?


RE: there is already several drugs for this...
By Greyguy on 12/31/2007 4:34:15 PM , Rating: 2
My wife suffers from narcolepsy. This quote "the nasal spray containing a hormone called orexin A is a promising candidate for sleep replacement therapy and likely treatment for the sleep disorder narcolepsy." could mean that she no longer needs to take Drugs to function normally. Wouldn't that be a better way?


By Master Kenobi (blog) on 12/31/2007 5:05:56 PM , Rating: 3
Still taking a drug, just this time its in the form of a nasal spray.


By Greyguy on 1/2/2008 10:31:46 AM , Rating: 2
This is a hormone produced by the body. Quote " Another study found that low levels of orexin A in the brain could be the main cause behind narcolepsy."


By mindless1 on 1/1/2008 7:55:09 AM , Rating: 2
The ideal and the reality are not necessarily the same. Treating a few monkeys in captivity tells us not so much about the effects on humans even in the short term, like the psychological effects. IOW, many things are "promising candidates", until negative effects are found. Just listen to the disclaimers cited for many drugs advertised on TV to remember that. Many of these negative effects, for those effected, seem almost worse than the primary problem but drug companies are more than willing to make a buck nevertheless.


Because we know...
By kzrssk on 12/31/2007 12:14:13 PM , Rating: 2
...arranging your day so you can get eight hours of sleep is too much to ask and all. We know doing the right thing for your body is out of the question, so we invented this drug with a handful of probable side-effects to keep you awake when you should really be sleeping so your brain and body can't do the full clean-up they need to do when you're asleep for eight hours.




RE: Because we know...
By Master Kenobi (blog) on 12/31/2007 1:15:31 PM , Rating: 2
Realistically Military Spec Ops missions can sometimes last longer than 24 hours and it would be best to keep those guys up and alert during deployment. Also consider the lifestyle of many IT professionals, were on call 24x7x365. This sort of thing would be great for the all nighters, middle of the night alarms, among other things. Frankly 8 hours of sleep is difficult since we spend ~12 working, that gives us maybe 4 hours to shower, shave, and get to and from work.

Sign me up for this, I'll test it. This sort of thing may not be entirely healthy in the long run, but usage will be heavy by many, especially in the Military and IT fields.


RE: Because we know...
By FITCamaro on 12/31/2007 1:58:54 PM , Rating: 2
I'd rather just not have a job that required that kind of work schedule. I work to live, not the other way around.

Talking about working in IT, not as a Marine or spec ops. Those guys deserve the best of everything to do what they do.


RE: Because we know...
By Armorize on 12/31/2007 5:25:33 PM , Rating: 2
Ya actually for some people it really is. I'm an electrician and with what ive been doing for the past year sometimes we have to stay up at least 15 hours. Although we've had a few jobs that we had to stay up 36 hours, and with what i'm doing its not exactly the best thing to be sleep deprived working around live wires. Sign me up too, as long as i feel normal, focused, and alert, and not ticky like i was high on coke or caffeine. It is a drug, but it is a hormone, its not like its a synthetic chemical, its natural. read the article before your post.


RE: Because we know...
By mindless1 on 1/1/2008 7:40:46 AM , Rating: 2
Natural doesn't necessarily make a difference. Coke IS "natural", if we want to stretch the point, as is coffee, ma huang, adrenalin,,,


RE: Because we know...
By kzrssk on 1/2/2008 10:39:50 AM , Rating: 2
I did read the article. You obviously did not. At the very end of the article Siegel states that's pretty ill-advised to take something that will reduce the need for sleep. Before that, Twery reinforces my point about the body not being able to do its regular, mid-sleep cleanup.

A drug or supplement being hormonal in composition does NOT guarantee its complete safety. Hormonal birth control can cause all kinds of health problems in women, like stopping them from conceiving for up to years after they stop taking it, or causing stroke or heart attack.

I got out of operational support IT because I wanted to have normal hours where I wouldn't be tired all the time and be woken up during the night. If you agree that staying up forever working isn't good, you should probably find a new boss that won't work you for 36 hours at a time. :P


Remember amphetamine use after WWII?
By RyanHirst on 1/2/2008 3:57:18 PM , Rating: 3
As a narcoleptic and a bibliophile, I happen to know a lot about this. So I thought I'd share.

The discovery of orexin (about 10 years ago) shed some light on the new wakefulness drug, Modafinil. Officially, Modafinil's method of action was/(is?) "unknown, but similar to that of amphetamine...". As it turns out, Modafinil reception has a significant correlation to orexin reception.
Now, Modafinil is advertised exactly like this nasal spray. Because it is schedule IV and not II (like amphetamine), it is marketed to sleepy truck drivers, swing-shift workers, etc. All advertising relies on the claim that it is safer than amphetamine.
FDA Schedules, by definition, are assigned based on the potential for nonmedical abuse, not the medical side effects (including addiction rates). Dextroamphetamine, for example, is physically nonaddictive (addiction/ tolerance rates below 1% among patients) -- but nonmedical abuse rates are high, and psychological addiction is also high among abusers.
In the FDA profile for Modafinil, you will find 1)the method of action is similar to amphetamine, 2)monkeys who autoadminister cocaine also autoadminister Modafinil, and 3)the FDA forbade the manufacturer from claiming any increased safety compared with amphetamines; such statements are fundamentally false.
Modafinil is Schedule IV for two principal reasons: 1) because it is hard to abuse. It can't be smoked, it doesn't dissolve easily. 2) It was pushed through testing quickly as part of the Orphan Drug act (without subsidies and incentives, pharmaceutical companies do not develop drugs for rare diseases, because they are unprofitable). Narcolepsy needed a drug that could be more easily obtained.
The FDA approved Modafinil for Narcolepsy only; the approval came with reservations: a serious lack of testing, in breadth of demographic, length of tests, and lack of information on high dosages.
About the same time, the FDA lost the power to control what illnesses a drug could be prescribed for. Modafinil's manufacturer states that its entire business model depends on aggressively marketing Modafinil outside its approved application. The heart of their marketing campaign is its safety and nonaddictiveness relative to amphetamines-- statements that are pharmacologically and medically unfounded, and would be a federal offense if included in the drug's official literature... but are permissible as advertising.
So it's in the newspapers; psychologists are talking about it. Everyone seems excited. Doctors who haven't done their research talk about a new era of wakefulness drug; they use the same language that was used for amphetamines in the early century. This new drug is different. "Unlike amphetamines...." Nevermind the FDA profile-- that its only direct pharmacological analogy is amphetamines.

So what does all this have to do with orexin? Well, Modafinil correlates significantly with it. It is probably recognized as orexin at at least one class of orexin receptors. (More is almost certainly known at this time, I just haven't read Cell magazine in awhile). To the extent that your body identifies Modafinil as orexin, administration of orexin presents the same medical concerns. There is nothing inherently safe about auto-adminstration of bodily substances. Lithium is a natural body salt. Heroin is recognized as dopamine (though it binds far longer), amphetamines are almost certainly recognized at various sites as (nor-)/epinephrine. Aside from poisoning yourself (e.g. alcohol), and disrupting natural processes (e.g. some hallucinogens), drugs work because your body recognizes them . The origin of a substance has no bearing whatever on its pharmacological action or consequences.

Carry on.




By JonB on 1/4/2008 1:18:53 PM , Rating: 2
Thank you, Ryan. A well written and informative post, unlike so many earlier ones.


By tcsenter on 1/4/2008 9:31:11 PM , Rating: 2
quote:
Now, Modafinil is advertised exactly like this nasal spray. Because it is schedule IV and not II (like amphetamine), it is marketed to sleepy truck drivers, swing-shift workers, etc. All advertising relies on the claim that it is safer than amphetamine.
False. Modafinil is not marketed or advertised direct-to-consumer/patient for off-label use, nor can any other prescription drug be marketed or advertised direct-to-consumer/patient for off-label use. Modafinil (and its R-Isomer Nuvigil) are approved for the treatment of the diagnosed conditions of obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), and narcolepsy.

Of course, drug companies can inform prescribing health care professionals about any potential for off-label uses, and prescribing physicians and pharmacists are keenly aware of the difference between off-label and on-label use. In those communications to prescribing professionals, drug companies often put the best possible spin on their drugs, which I am as critical of as anyone, but prescribing health care professionals are as keenly aware of this spin as anyone and furthermore have the training to know how and where to obtain more independent or objective information to counter or cross-check the drug company's spin.

If I'm familiar with resources like the PDR, MedLine, medical journals, and FDA drug packages, physicians and pharmacists sure as hell know about them.
quote:
3)the FDA forbade the manufacturer from claiming any increased safety compared with amphetamines; such statements are fundamentally false.
No, the safety of modafinil relative to amphetamine has not been proven by evidence that FDA considers adequate (i.e. controlled systematic clinical trials instead of pre-clinical or animal models). This is quite different from saying that the safety of modafinil is proven to be no better than amphetamine, thus making the aforementioned claims fundamentally false.

In fact, the side-effect profile of modafinil is indisputably more favorable than amphetamine, but that isn't conclusive or adequate enough to make boilerplate or generalized claims that modafinil is more safe than amphetamine, which has not yet been disproven or proven.
quote:
2) It was pushed through testing quickly as part of the Orphan Drug act (without subsidies and incentives, pharmaceutical companies do not develop drugs for rare diseases, because they are unprofitable). Narcolepsy needed a drug that could be more easily obtained.
No, narcolepsy needed better drugs because it needed better drugs - the old CNS stimulants were hardly some panacea for narcolepsy. The majority of narcolepsy cases are not adequately controlled by the standard therapies which include CNS stimulants, drug tolerance is a problem more so with amphetamine-based CNS stimulants than most other drugs (second only to opiates), and the side-effects are also a problem for many.

If narcolepsy needed a drug that could be more 'easily obtained' with less restrictions, then how do you propose to explain Sodium Oxybate (Xyrem), whose active substance (GHB) is the most tightly controlled Schedule I, banned by federal law except for medical research and narcolepsy, approved ONLY for the treatment of narcolepsy/cataplexy (under Schedule III), and cannot be prescribed off-label?

Not everyone can tolerate any given first or second line drug that is effective for others. With narcolepsy, there was a small percentage who responded very well to first-line CNS stimulants, the vast majority had to settle for varying degrees of inadequate effectiveness and side effects.
quote:
The FDA approved Modafinil for Narcolepsy only; the approval came with reservations: a serious lack of testing, in breadth of demographic, length of tests, and lack of information on high dosages. About the same time, the FDA lost the power to control what illnesses a drug could be prescribed for.
False. The FDA did not 'recently' lose any power to restrict off-label prescribing. Physicians have always been free to prescribe off-label when the circumstances warrant it. The FDA has always supported the physician's ability to prescribe off-label, provided it is not done willy-nilly and is based on sound medical reasons (e.g. patient is not responding to or cannot tolerate first and second line treatments).

I would add that modafinil is the primary metabolite of adrafinil, which has been widely used in Europe for 20 years now and whose safety profile is well established. Adrafinil is reduced to modafinil in the body and it is that primary metabolite that is the active compound.
quote:
This new drug is different. "Unlike amphetamines...." Nevermind the FDA profile -- that its only direct pharmacological analogy is amphetamines.
And your point? The essential amino acid phenylalanine is even more closely analogous to amphetamine than either Provigil or Ritalin. You can take a gob of phenylalanine and you're not going to get a buzz from it.

Molecules are like that. You remove a single hydroxyl group or break a single covalent bond, and bam you've got something with completely different properties. For being a "bibliophile", you sure don't seem to understand much of what you read.

BTW, I was diagnosed with narcolepsy and cataplexy in 2002, though I had symptoms for over 10 years prior. I was initially prescribed Provigil but developed the skin reaction that is now the subject of new severe reaction warnings for Provigil and Nuvigil: http://www.fda.gov/cder/dsn/2007_fall/postmarketin...

My reaction was not severe and resolved without complication after discontinuing Provigil. I've been on methylphenidate (Ritalin) ever since, which I tolerate well but it doesn't really help a whole lot, in the grand scheme of things.


YES!
By smitty3268 on 12/31/2007 6:36:55 PM , Rating: 3
I keep falling asleep after about 70 hours of straight WOW play, I'll bet I can go 150 with this!




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