MODAFINIL TREAD ADHD, ENERGY

[Opus]

THIS DRUG IS ONLY SCHEDULE FOUR, LESS SEVERE THAN AAS



A New ADHD Drug on the Horizon.

A new ADHD drug, Attenace, will likely hit pharmacy shelves in early 2006. This "new" ADHD drug isn’t actually so new to the about 20,000 people currently taking Provigil "off-label" for ADHD. Attenace contains modafinil, the same active ingredient in the narcolepsy drug Provigil.

Modafinil is a stimulant drug that is chemically unrelated to the other stimulant ADHD medications. Although Attenace is a stimulant medication, it is not classified as a controlled substance under the Controlled Substance Act. This translates to the convenience of phone-in refills and less prescription hassles at the pharmacy.

Attenace has a different chemical structure but it still poses many side effects consistent with the side effects of the other stimulant ADHD medications. There are also a few new side effects, like sexual dysfunction, that adults might find less than pleasant.

Before you knock on your doctor's door asking for a prescription, there are a few things you should know about this new ADHD medication.

First, it is not known how well Attenance will work or how it compares in effectiveness to the current ADHD drugs since the three trials conducted on Attenace only compared Attenace to a placebo instead of to its potential competitors. Cephalon conducted three 9-week double-blind, placebo-controlled studies of more than 600 children and adolescents between the ages of six and 17 with ADHD. Cephalon reports that Attenace "significantly improved" the symptoms of ADHD in children and adolescents, when compared to placebo, in three studies of the drug.

Secondly, Attenace (modafinil) has side effects ranging from mildly disturbing to potentially life-threatening. Given the relatively small test sampling to date, Attenace side effects are not fully known at this point. It can be assumed that Attenace will have similar side effects to Provigil since they are made from the same drug.

Below are a listing of common Provigil (modafinil) side effects.
_ Headache.
_ Blurred vision.
_ Dry mouth.
_ Nausea, vomiting, abdominal pain.
_ Constipation or diarrhea.
_ Sleep disturbances/insomnia.
_ Loss of appetite/weight loss.
_ Stuffy nose.
_ Back pain.
_ Confusion.
_ Anxiety and agitation.
_ Nervousness, aggression, hostility.
_ Unstable moods.
_ Depression.
_ Decreased sex drive.
_ "Pins and Needles" feeling.
_ Rash or itching.
_ Dizziness.
_ Widening of blood vessels.
_ Weakness or loss of strength.
_ High/increased blood pressure.
_ Alteration in results of liver function tests.
_ Chest pain.
_ Increased heart rate.
_ Drug dependence.
_ Allergic reaction.

Attenace may be habit forming and has the potential for abuse and dependence . You should discuss the abuse and dependence potential of Attenace with your doctor. This drug should not be taken by anyone who has been or currently is dependent on alcohol or drugs.

Symptoms of an Attenace overdose might include excitation, agitation, insomnia, sleep disturbances, anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, nausea, and diarrhea.

Contact your doctor immediately or seek emergency medical attention if you experience any of the following uncommon but serious side effects:
_ An allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
_ Irregular heartbeats.
_ Low or high blood pressure.
_ Shortness of breath.

Before taking Attenace, tell your doctor if you have;
_ Left ventricular hypertrophy.
_ Chest pain.
_ Irregular heartbeats.
_ History of heart attack.
_ High blood pressure.
_ Unstable angina.
_ History of mental illness.
_ Kidney disease
_ Liver disease.

Attenace, along with all other ADHD medications currently on the market, is not recommended for children under the age of six since its safety and effectiveness has not been determined. Despite ADHD drug manufacturer's own labels warning against prescribing these powerful drugs to young children, doctors increasingly prescribe ADD medications to children under the manufacturer recommended age.

A Journal of the American Medical Association (JAMA) article in 2000 noted a "disturbing" increase in the amount of stimulants and anti-depressants prescribed for children under the age of five. Parents should carefully consider the health effects of placing small children on powerful ADHD medications, even if the child's health care provider prescribes a medication for ADHD or ADD.

People using ADHD medications know that these little pills are never the "cure-all" answer. Attention Deficit requires a multifaceted approach which requires many different tactics and combination of tactics. What works is highly individual, depending on individual needs.

Many people with Attention Deficit Disorder and parents of children with Attention Deficit Disorder find great Attention Deficit Disorder and ADHD success from diet supplementation - especially with amino acids and essential fatty acids - a shift in parenting tactics, modifying the home and school environment, biofeedback, neuro-linguistic programming, stress relief measures and exercise. The greatest successes are found by being bold and trying a combination of many measures.

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[Opus]

Wakefulness Finds a Powerful Ally
By ANAHAD O'CONNOR

Laurie Coots, a marketing executive who flies to meetings in other countries twice a week, spent years trying to conquer sleepless nights and chronic jet lag. But nothing worked, she says, and every day was a struggle to stay awake.

"It was debilitating," said Ms. Coots, 46, who is from Los Angeles. "I couldn't give an effective presentation because I was always shaky and nervous from being amped up on caffeine and stimulants."

Then she found modafinil, a small white pill that revs up the central nervous system without the jitteriness of caffeine or the addiction and euphoria of amphetamines.

"Without it my life would not be possible," she said.

Since 1998, modafinil, made by Cephalon and sold under the brand name Provigil, has quietly altered the lives of millions of people. No one knows exactly how it works, but sales of the drug are skyrocketing.

People who take it say it keeps them awake for hours or even days. It has been described as a nap in the form of a pill, making most users feel refreshed and alert but still able to go to bed when they are ready. And because its side effects are rarely worse than a mild headache or slight nausea, experts fear that it has rapidly become a tempting pick-me-up to a nation that battles sleep with more than 100 million cups of coffee a day.

Few numbers are available, but experts say that as modafinil grows more widely available, it is becoming a fixture among college students, long-haul truckers, computer programmers and others determined to burn the midnight oil. Some worry that an array of common disorders, like diabetes and sleep apnea, will go undiagnosed if doctors dole out Provigil instead of seeking the underlying diseases that cause fatigue.

In a culture of 24-hour stores, graveyard shifts and coffee shops on every corner, modafinil might also pose a more subtle danger: to the countless Americans in search of an extra edge, modafinil could be a cure for sleep.

"This drug enables us to be that much more workaholic and that much more obsessed with accomplishments and productivity, and I think our society is already extreme along those lines," said Dr. Martha J. Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania. "The natural checks on that tendency, like needing to go to bed, are being rolled back by modafinil."

To the extent that modafinil becomes the latest lifestyle drug, as ubiquitous as Viagra, scientists warn that cutting back on sleep, even by one hour a night, can have long-term neurological and cardiovascular effects that are only now being recognized.

"It's almost fortuitous that at the same time that this drug has come out, we have increasing mounds of data showing that sleep is a restorative, protective health process," said Dr. Neil B. Kavey, director of the Sleep Disorders Center at Columbia Presbyterian Medical Center. "It affects performance, blood pressure, heart rate, insulin, various hormone secretions. No matter what medications come out that make sleep seem like a waste of time, we know that the sleep-deprived state is a bad one to be in."

Discovered by French researchers in the late 1970's, modafinil went on the market in the United States in 1998 as a treatment for narcolepsy, a severe sleep disorder. Earlier this year, the Food and Drug Administration broadened its approved uses to include obstructive sleep apnea, a narrowing or blockage of the airways, and sleeping problems caused by shift work. An effort by Cephalon to have the drug approved for a third indication, excessive sleepiness from any cause, was rejected.

But the three conditions modafinil is approved to treat make up only a fraction of its total uses. According to Cephalon, based in West Chester, Pa., 90 percent of all prescriptions for the drug are for "off-label" uses, including fatigue, depression, attention deficit hyperactivity disorder, and sleepiness caused by other prescription medications.

In the last year, six American track and field athletes have tested positive for the substance, which is on the United States Olympic Committee's list of banned stimulants. One group of scientists is testing its effectiveness as an appetite suppressant in people who are overweight. And a government-financed study found that it blunts the high produced by cocaine, making it a promising treatment for addiction.

"The off-label use of this drug is staggering," said Dr. Eric Heiligenstein, a psychiatrist at the University of Wisconsin who studies substance abuse by teenagers.

"This is a very clean drug that affects all the things that help people with their cognitive functioning," he said. "The main barrier to more widespread use is that it's expensive, which will change as more insurance companies start to cover it."

For doctors, modafinil's biggest lure is its safety profile. It was used in France for several years without reports of major problems before reaching the United States. In clinical trials, only about 1 percent of people complained of side effects, including nausea, mild headache and nervousness.

But scientists point out that as with any drug, more serious side effects could appear as modafinil is used more widely.

"I'm not aware of any terrible outcomes, but I don't think there have been enough long-term studies of modafinil to rule out all dangers," said Dr. Jerome M. Siegel, chief of neurobiology research at the Veterans Affairs Greater Los Angeles Healthcare System. Total worldwide sales of Provigil soared above $290 million in 2003, up from $207 million in 2002. Marc Goodman, a pharmaceutical analyst at Morgan Stanley, expects that figure to reach $409 million this year. More than 90 percent of that revenue, he said, will come from sales in the United States alone.

"If you look back before the drug was launched, no one would ever have believed it would be this big," Mr. Goodman said. "Everyone viewed narcolepsy as the market and didn't appreciate the benign side-effect profile and how that would play into off-label uses."

Between 2002 and 2003, Provigil's share of the stimulants market grew by 39 percent, according to IMS Health, a company that tracks the pharmaceutical industry.

In the near future, modafinil could find its way into even more medicine cabinets. Mr. Goodman said it was likely that Cephalon's patent for the compound would be challenged by several drug companies seeking to market generic versions. If they succeed, it would increase the availability of modafinil and almost certainly drive down the price of a monthly supply, which is now $120 or more.

Cephalon is working on Provigil's successor, a longer lasting version the company calls Nuvigil. It also hopes to win approval for modafinil as a treatment for children with attention deficit disorder, the most commonly diagnosed behavioral disorder of childhood. Some experts think this would open the door to the drug becoming even more of a household name.

Of all the questions surrounding modafinil, perhaps the most intriguing is how it works. After more than two decades of research, scientists are still trying to figure out just how it manipulates the brain.

"It is amazing that this drug has become so widely used without any real understanding of the basic science behind it," Dr. Siegel said.

Researchers know that modafinil is distinctly different from conventional stimulants, which ramp up arousal and set off a flurry of activity throughout the brain. Such stimulants, like cocaine and amphetamines, for example, produce wakefulness but also produce a high and can lead to dependence. Modafinil appears to steer clear of those side effects by aiming at specific structures and chemicals.

One neurotransmitter that is thought to be involved is dopamine, which mediates the reward pathways in the brain, producing euphoria, pleasure and addiction. Cocaine and amphetamines cause a surge in dopamine levels, while modafinil's effects are much weaker. A study of animals lacking a protein that helps process dopamine found that they did not respond to modafinil.

Dr. Thomas Scammell, an associate professor of neurology at Harvard's medical school who was involved in preclinical trials of the drug, believes that modafinil may home in on a single poorly understood dopamine circuit that is specific for wakefulness, while amphetamines and other stimulants activate all three of the brain's dopamine pathways, including those involved in addiction and locomotor activity. That selectivity, he said, might be crucial in modafinil's lack of unwanted side effects.

"I think it is a subtle enough drug that it doesn't just activate everything," he said.

Modafinil's impact on the brain is so subtle that brain scans of people who have taken it hardly register any change in activity at all. Give them amphetamine or a drug for Parkinson's disease, Dr. Scammell said, and "the changes in brain function are spectacular," but give them modafinil, and they show little more than ordinary wakefulness.

Most scientists suspect that at least three other transmitters are involved. One of them, histamine, is responsible for the sleep-inducing effects of many cold and allergy medications. In a study last month, Dr. Siegel, who is also a professor of psychiatry and biobehavioral sciences at the University of California at Los Angeles, found that histamine in the brain helps control consciousness.

In the rapid-eye-movement stage of sleep, lower levels of norepinephrine and serotonin keep the body still, producing the characteristically slack muscle tone of sleep. Lower levels of histamine, however, specifically reduce consciousness and awareness. In studies on animals last year, Japanese researchers found that modafinil releases histamine. French researchers this year found that it elevates levels of norepinephrine. And a smaller number of scientists suspect minor involvement by orexin, a substance that is severely depleted in narcoleptics.

Several researchers, including Dr. Siegel, have proposed a unified theory suggesting that all these chemicals are necessary for modafinil to take effect.

"Many things have to work together to achieve alertness," he said. "Modafinil might activate dopamine, which then activates norepinephrine, which then activates histamine, for example. But we still want to know where the initial action is."

Scientists think that the chain of reactions set off by modafinil leads to the hypothalamus, a small structure embedded in the forebrain that controls the body's hormones and regulatory functions. One part of the hypothalamus, known as the ventrolateral preoptic nucleus, appears to act as the body's sleep generator. When it is active, it produces a chemical, GABA, that inhibits the firing of cells involved in wakefulness and arousal. Scientists suspect that by increasing norepinephrine levels, modafinil may block the region from promoting sleep.

Just next door, in the posterior hypothalamus, are bundles of thousands of neurons that produce histamine. Damage to this region, scientists have found, causes excessive sleepiness. Dr. Rod Hughes, senior director of scientific communications for Cephalon, thinks the histamine center may generate wakefulness, counteracting the effects of its sleep-inducing neighbor. Modafinil might increase output in this region, coaxing a tired body into switching on its natural alertness system.

Some scientists say that regularly manipulating this system to skimp on sleep could have dire consequences. Studies have shown that chronic sleep deprivation damages health, weakening the immune system and increasing the likelihood of illness. It is also associated with a shorter life span.

But other experts counter that Americans will continue to cut back on sleep, whether they have modafinil or not. The toll of this deprivation has been visible for years on the nation's highways, where impaired judgment from sleepiness is blamed for about 100,000 accidents a year. Lack of sleep is also believed to have played a role in the space shuttle Challenger disaster, the nuclear meltdown at Chernobyl and the Exxon Valdez oil spill.

"In terms of error rate, 18 hours of no sleep, which many of us regularly do, is equivalent to a blood alcohol level of about .05," said Dr. Ronald Chervin, who was involved in clinical trials of modafinil and is the director of the University of Michigan sleep disorders center. "Twenty-one hours of no sleep is equivalent to a blood alcohol level of .08, which is illegal in many states."

If someone is falling asleep on the highway, and has no other option than driving to work, Dr. Chervin said, "I think many sleep experts would give that patient modafinil, and I think many do."

Dr. Farah, at the Center for Cognitive Neuroscience, is more concerned about the people who are taking modafinil simply so they can get ahead at work or finish a term paper. As it becomes more and more popular to use it for those reasons, she said, people might feel they have to take it just to seem as if they are performing normally.

"It would be a shame for a generation of young adults to come of age believing that the only way they can take on a challenging project is with some kind of pharmacological help," she said. "It's quite possible that modafinil will be the next Ritalin on campus, something that kids go off to college with. If it is widely used for A.D.H.D., then it will probably end up being readily available to the undergraduate masses."

[Opus]

IF you would like to see this please post in the special offers section under
MODAFINIL INTEREST CHECK

[Backlum Chaam]

I was prescribed this a few years ago. Graduated to Concerta (time-release ritalin). Provigil is good stuff. I had better energy and focus without jitters. And I didn't find it habit-forming despite a history of substance abuse. Of course being ADD, I think I probably react differently to stimulants than other folks.

[truck]

all it does for me is give me dry mouth... Wish it was more like ephedra or stronger.

[inertia]

i've used provigil in the past for ADD . I liked it . It gave me a good sense of well being as well as more focused. I recently got modalert and didn't like it as much as other underground sources.

[thebeliever]

OPUS, where's the MODAFINIL INTEREST CHECK thread? I don't seem to be able to locate it. Thanks.

TB

[bronson1]

whats up brothas- been a member here for a bit, and a member over at OS for over 5 years- I don't post much, but I felt compelled to on this thread. In my opinion Provigil has worked wonders for me. I have pretty bad ADD, diagnosed around age 14, and I still have to take medication sometimes to focus. I am currently on Adderall xr, which although effective, obviously is accompanied by some bad sides. Besides the obvious health side effects, my biggest problem with adderall is the effect it has on my training- I am a VERY active Brazilian Jiu jitsu student, training 5 days a week, sometimes twice a day. The XR helps me with the technical aspect of the sport, which as any BJJ guy knows is just as important as live training. I am able to learn more and focus on technique when I take it, but for the live training, addy absolutely sucks. My heart rate is always higher than it should be when I roll live, and my cardio sucks when I take it. This is where provigil has been so helpful, as it not only helped me focus, but actually improved my ability to control my breathing while training live. After all the good bro's retired, it was hard to obtain, so I switched back to addy for a short period of time. My purpose for this post is out of frustration, as today I was prescribed provigil by my doc as an alternative to addy for a trial period. I got a script for ten tabs, and when i returned to pick up my script, my insurance had refused to fill it. Because it is so expensive, they must have an approval from my doctor, as they will not pay for this med unless it is a necessity (not ADD, only narcolepsy sleep apnea, with corresponding tests). When I asked to pay out of pocket, the ten tabs would have cost me 130.00!! I almost s**t myself when I heard this. It is just unfathomable to me that a drug which is far easier on the CNS, as well as has far less addiction potential would not be supported by insurance companies. This med was not only more effective for me as far as ADD goes, but its safer, milder, and has far less potential for dependence/abuse. I knew it was expensive, but damn- it's just a shame that not only to I have to go through all this nonsense to get authorization, but also that the good old days around here are done with. Hopefully through time this med will be recognized for its many uses, and this insurance/pharmaceutical crap will end. 130.00 dollars for (10) tabs. F'in crazy!

[noname]

Well, there are other ways of finding this medication, especially if you are in a place where you can receive things from international places. I've had luck with airsealed.com, but that was before they stopped shipping to Hawaii.

If you're on the mainland, though, you shouldn't have any problems. And the one time that mine did get seized, they gave me a full refund, though I can't guarantee you'll get the same results, but at less than $2.00 for a 200 mg tab, what have you got to lose by trying?

[fulforb]

I have Narcolepsy and have been prescribed Provigil for the last 3 years or so. It's about the only thing that keeps my able to function and it doesn't mess with my stomache like ritalin did or ECA does.