I've been taking modafinil lately and I feel like I am seeming to see improvements in my diagnosed add. There are definitely less side effects in comparison to other treatments, although there is some emotional blunting, which could be good or bad depending upon how you look at it. The most exciting aspect of this is that there is supposedly no rebound. I took a day or two off and seemed to experience this for a bit, I guess I will have to see how it goes in the future though..I've only been taking it for a bit. Perhaps instead of chronically taking a drug, one can take it for a certain time period and then get off of it and still enjoy the effects...or perhaps I just have wishful thinking.

Here is the article, discuss:

http://www.neuropsychiatryreviews.com/aug05/modafinil.html

PHASE III TRIALS DEMONSTRATE MODAFINIL EFFICACY IN ADHD

ATLANTA— Two phase III clinical trials presented at the 158th Annual Meeting of the American Psychiatric Association show that pediatric formulation modafinil is an effective new treatment for ADHD in children and adolescents and might be a safer alternative to the stimulant drugs now used.

INCREASED ALERTNESS AND TASK PERFORMANCE

In the first trial, James M. Swanson, PhD, Director of the Child Development Center at the University of California, Irvine, and colleagues evaluated the new modafinil pediatric formulation in children and adolescents with ADHD. “Modafinil increases alertness and task performance. It has been shown to be very effective and is widely used to treat excessive sleepiness, particularly narcolepsy. It appears to activate the prefrontal cortex in a different way than the stimulant drugs, and exploratory studies in attention-deficit disorder had looked at potential doses that might be effective for the treatment of ADHD,” Dr. Swanson said. “The next step was to try to adapt modafinil for pediatric use with a smaller, easier- to-take formulation targeting the doses the initial study suggested were the optimal for the treatment of ADHD.”

Dr. Swanson reported data from a nine-week, double-blind, placebo-controlled trial looking at flexible dosing with the new film-coated tablets of modafinil. The trial enrolled 194 patients ages 6 to 17 who met DSM-IV criteria for ADHD. All subjects were at least moderately ill by the Clinical Global Impression (CGI) rating, had normal intelligence, and were attending school full-time. Exclusions included failure to respond to previous stimulant therapy and untreated psychiatric comorbidities. One hundred twenty-eight patients were randomized to modafinil and 66 to placebo in a two-to-one randomization.

Patients randomized to modafinil had a starting dose of 85 mg titrated for a period of 22 days to clinical effect with once-daily dosing. The maximum dose was 425 mg/day. “The majority of the modafinil-treated group ended up on 425 mg per day,” Dr. Swanson said. Efficacy was assessed with the School (teacher-rated) and Home (parent-rated) ADHD rating scale (ADHD-RX-IV), the Clinical Global Impression of Improvement (CGI-I), and the Test of Variables of Attention (TOVA).

The modafinil-treated patients had significantly greater improvement on the teacher-rated scores than did placebo-treated patients (-17.5 versus -9.7 mean change, respectively). The modafinil-treated patients also had significant improvement in the parent-rated scores (-17.5 versus -7.5). Dr. Swanson said that modafinil significantly improved the inattention and hyperactivity/impulsivity ADHD-RS-IV subscales, the overall clinical condition as measured by the CGI-I, and the TOVA measurements of ADHD. “Parent observations favor modafinil, particularly regarding the impact on parent time, on emotions, and on social skills. This represents an increase in positive as well as a decrease in negative behaviors,” he remarked.

The most common adverse effects were insomnia (28% modafinil versus 7% placebo), headache (22% versus 9%), and decreased appetite (18% versus 3%). “These are the typical side effects observed with stimulants as well. Insomnia and appetite effects occurred early on and tended to decrease over time. Treatment discontinuation due to these factors was very rare,” Dr. Swanson said. There were no clinically significant changes in vital signs or in electrocardiographic, or laboratory parameters, and no serious adverse events. Weight loss occurred, but it was not clinically significant.

AFFECTING THE NETWORK OF ATTENTION

Dr. Swanson acknowledged that modafinil’s mechanism of action in ADHD is unknown, but he proposed a possible mechanism in the context of the neuroanatomical network theory of attention. This theory proposes three underlying processes of attention: alerting, orienting, and executive control. Alerting networks are thought to reside in the right frontal cortex, and increasing wakefulness or alerting might improve that component of attention. Such stimulation might also interact with executive control.

“Dopaminergic neurons and the ventral tegmentum area of the substantia nigra project up into the caudate nucleus and the nucleus accumbens, and also directly into the anterior cingulate gyrus and to the prefrontal cortex,” Dr. Swanson said. “The stimulus operates by blocking the reuptake of dopamine, primarily in the caudate nucleus and the nucleus accumbens, and activating the cortical striata thalamic loops. The activation of the cingulate gyrus and the frontal cortex has been well studied with stimulant drugs, which have been used for over a half century to treat attention deficit disorders.”

Instead of this bottom-up effect of blocking the dopamine transporter, Dr. Swanson proposed that modafinil might activate the anterior cingulate cortex. This, in turn, might affect executive function and alertness in ADHD.

EFFECTIVE DOSING

The second modafinil study presented was from Joseph Biederman, MD, and colleagues at Massachusetts General Hospital, Boston. They reported that the new modafinil pediatric formulation, given using weight-adjusted once-daily dosages, is effective and well-tolerated even with rapid dose escalation, and that this formulation does not cause withdrawal or rebound symptoms if suddenly stopped.

Patients in this study were similar to those in the Swanson study (ages 6 to 17, met DSM-IV criteria for moderate to severe ADHD). The protocol was a double-blind, placebo-controlled, two-to-one randomization to modafinil or placebo. Twenty patients were randomized to seven weeks of modafinil and 63 patients to placebo, followed by two weeks of withdrawal study. During the withdrawal period, half of the modafinil-treated patients were converted to placebo without dose tapering, and half continued taking modafinil. “This was to examine the effect of a common event, such as patients flushing their medications down the toilet after an argument with their parents,” Dr. Biederman said. “We wanted to know the consequences of stopping abruptly if you are taking a reasonably high dose.” Dr. Biederman is Chief of Clinical and Research in Pediatric Psychopharmacology at Massachusetts General Hospital and Professor of Psychiatry at Harvard Medical School.

Modafinil was given once daily, starting at 85 mg/day and increasing for a period of seven or nine days to 340 mg for patients weighing less than 30 kg or 425 mg for patients weighing more than 30 kg. Efficacy was assessed with both the School and the Home ADHD-RS-IV total score change from baseline to last on-treatment visit.

“After one week, the modafinil-treated patients had significantly greater improvement in School ADHD-RS-IV scores versus the placebo-treated patients and the effect was maintained through week 7,” Dr. Biederman said. The improvement in School ADHD-RS-IV at week 7 was -17.2 for patients receiving modafinil versus -8.2 for those receiving placebo. Modafinil also significantly improved total scores on the Home ADHD-RS-IV. Dr. Biederman noted that patients continued to improve over the ensuing weeks after reaching the upper dose level.

NO REBOUND

ADHD symptoms did not rebound when placebo replaced modafinil, and the most common adverse effects were similar to those in the Swanson study: insomnia, headache, appetite decrease, and abdominal pain. “They were related to treatment initiation and generally resolved with continued treatment. There were very few discontinuations as a result of adverse effects. Weight loss was statistically significant but there was a very modest change in weight,” Dr. Biederman said.

The lack of rebound or withdrawal after abrupt discontinuation is likely to be an important point for clinicians. “The activation of dopamine not only impacts on the cortex, where the old medications work, but also affects other areas, such as the nucleus accumbens, and as a result the potential for abuse is a hazard,” Dr. Biederman said. “Modafinil is a scheduled drug, but it is a schedule IV drug, which is a big difference in practice for the practitioner as well as for the patient.”

“In summary,” Dr. Biederman concluded, “modafinil was effective in improving ADHD symptoms and behaviors. There was consistent and sustained improvement in school and after hours as reported by parents. A significant treatment effect was observed by week one. That was the week that the titration was completed. Symptoms and behaviors improved and as maintenance treatment continued, there was continued improvement.”

Yeah, it works, as far as rebound, it is all about eating, sleeping and exercising on schedule. If you screw up your circadian rhythm with it, which is easy to do, you have rebound problems.

Yep. Modafinil is damn near the best stimulant modern medicine has to offer for us (therapeutically).

No crash.
Little side effects (when used carefully).
High energy output.
No jitters.
etc

The only problem is Cephalon (makers) knows this and it is expensive as balls. Combine that with the fact that the FDA has approved it ONLY for narcolepsy (and, even more so, smacked down proposal for ADD certification) and chances are your insurance wont cover it leaving you with alot of out of pocket expense. (Easily over $100/mo)

Good luck. I try to coax a few samples out of the doc when I can but thats as far as I go with that.

Why is the FDA not for ADHD use? Pushing a non-recreational drug seems to be the usual method, even if they aren't as effective (eg, ssris over benzos)

Interestingly, Modafinil was rejected for concerns over safety rather than efficacy. This was around the same time that Canada pulled Adderall over concerns regarding heart health and "sudden death." Big blow to Cephalon, who invested a lot of money in research for use in ADD/ADHD, and probably why the drug is used "off-label" by physicians at a rate of around 90% (Cephalon also paid a large settlement to the FDA for apparently marketing the drug for non-approved uses).

I believe it's going through trials, but I don't know.

I know I managed to get my doctor to give me a script for modafinil, but since it not for narcolepsy, my insurance didn't cover it (actually, maybe I'm wrong here, I think we managed to get something). It was like $600 for 30 200mg pills.

Shire has a very strong grip on the ADHD market. First Adderall, then Adderall XR (patent not due to expire until 2018 if I'm not mistaken), Strattera, Vyvanse, and they're working on an amphetamine transdermal system. The two-toned capsules have a definite place in countless doctors', parents', and patients' minds, and "the 'go-pill' used for narcolepsy and extended military missions" does not. Generic modafinil will be reasonably priced eventually, hopefully.

Side effects are a bitch for me at higher dosages. I mostly like it after periods of "dopaminergic enhancement" like Ritalin. A few days of moderate dosing to lessen the crash from the other stuff. Tried chronic 200 mg in the morning for a longer duration and had crappy sleep that didn´t resove.

Makes me wonder if one could try the CFS (Chronic Fatigue Syndrome) route and have insurance pick up the cost.

Interesting article On Chronic Fatigue Syndrome

I have tried modafinil just a very few times, but they were enough to realize that this drug is a waste. It doesn't give a euphoric feeling whatsoever, it doesn't seem to improve focus and/or motivation to study/read and, as someone already pointed out, it makes sleeping next to impossible. This drug is just a flawed attempt to bring a replacement for amphetamines, but without rewarding effects, to the market.

The effects that everyone is expecting out of modafinil can be reached way better with something like geranamine+caffeine (add zingerone and it's still better); at the same time you avoid the nasty side effects on sleep this crap called modafinil gives.

Everyone who is fooled into taking this by his doctor should refuse the prescription with a "if you are not going to prescribe amphetamine or methylphenidate, don't waste my time with this crap, I'm far better off taking nothing".

We don't want euphoric effects because all euphoric effects eventually turn into a cycle that leads to depression or some sort of crash afterwards.

That is the beauty of the drug. The purpose of the use of amphetamines is not to get a euphoric feeling. It is to either improve focus or keep someone awake. The euphoric feeling (although nice) is really a downside as it messes with your serotonin and probably a whole host of other things that eventually leads to depression.

Modafinil accomplishes the original goal of amphetamines without messing with other systems.

+1. summed up my thoughts exactly.

[quote name='liorrh' date='Apr 9 2008, 03:33 PM' post='471040']
+1. summed up my thoughts exactly.
[/quote


ideopathic narcolepsy. this will get the insurance companies to sign on.

Modafinil is simply not very effective in treating ADD. It's also expensive.

It's basically a shitty drug with low efficacy, so it's not terribly surprising you don't notice being off the drug so much when being on the drug is an experience more underwhelming than a Red Bull.

Political correctness should never compromise medical treatment.

Ummm...Provigil was designed and is indicated for narcolepsy and shift-work hypersomnia so the fact that it produces no euphoria and "makes sleeping next toimpossible" should not really be seen as a negative side effects...