In light of the recent articles popping up about a clinical trial revealing Modafinil’s “inefficacy” (a subject which was denounced here on this blog), I felt compelled to seek out some other clinical trial results to explore some of the other findings regarding this modern marvel of medicine.
Poring through various clinical trials revealed a great deal about Modafinil’s potential for new applications. While it is currently only marketed and approved for sleep disorders, there are a number of trials that have been completed and many more still underway that aim to apply Modafinil to other types of ailments.
ADHD has become a growing phenomenon in western civilization, primarily in the United States and the UK. More and more students are being diagnosed with ADHD, and while the cause of this rapid spike in patients is a subject of much debate, the solutions have been fairly explicit. Common wisdom is to prescribe an amphetamine-derived medicine such as Ritalin or Adderall. In young children, these seem to have a concentrating effect that helps hyperactive kids to settle down, focus, and study. Likewise, these same drugs have been used outside of their original scope for students. Ritalin has been used by over 20% of some student bodies. Even though some of these students are using it recreationally, many others find it helps them to study and stay focused for long periods of time.
Therefore, we can see an interesting parallel between these frequently prescribed ADHD drugs and Modafinil. Modafinil has grown very popular among students for its ability to increase focus and impart energy for long durations. Apparently, some researchers felt it would be interesting to see if this effect could translate to ADHD students in the same way Ritalin and Adderall do.
The results are astounding. In one large trial backed by Cephalon, the maker of Modafinil’s brand name product Provigil, over 900 students have been given Modafinil. Interestingly, a large single dose of 300mg has proven most effective. Most of the children are under 12 years old, and the trials had far more boys than girls. Boys generally have a higher likelihood of being dosed with ADHD. Over 50% of the participants showed a noticeable benefit over placebo, with the overall improvement being identified as roughly 30%. In order to measure students, school faculty used the ADHD-RS-IV School Version test. You can see it for yourself: ADHD test for schools. The total scores dropped from nearly 40 to just under 21.
Only 1% of the students dropped out due to adverse effects, which most noticeably were loss of appetite and headaches. These effects are well known to adults, who can take steps to manage them. It’s much harder to force a child to eat, however.
Why is Cephalon Testing Modafinil for ADHD?
Modafinil is currently not approved by the FDA for treatment of ADHD symptoms. However it’s important for us to note how the drug market works. If a drug is found to be useful for a new type of treatment, the original company can re-gain its patent application for this specific us. This means that Cephalon, who is currently losing a great deal of money due to generic manufacturers, can acquire a new patent that requires doctors to only prescribe Provigil as the treatment for ADHD, and generics will again be left out in the cold. The limit for this type of patent is 3 years, and it is only granted if the company has invested money into the trials. The aforementioned trial is by far the largest, and has completed Phase 3 testing, meaning that upon publication of the results, Modafinil may be approved for ADHD treatment. As a result, Cephalon would reap all of the profits for the next 3 years.
Should my Child Take Modafinil for ADHD?
This site is not intended to diagnose or treat any disease or condition, and you should always talk with a doctor beforehand. However, given the rapid progress of clinical trials, the proven safety of Modafinil in adults and so far in children, it seems inevitable that it will be cleared for this application. Given that Modafinil is available in generic form, it would make sense to purchase it this way as opposed to paying for the brand name prescription drug that will be released, and will cost a great deal more.
Modafinil could in fact benefit your child’s ADHD symptoms. If your child is already taking medicines such as Ritalin or Adderall, generic Modafinil could be a cheaper and safer solution. Amphetamines are known to have addictive properties and tolerance does build. So far, the clinical trials of Modafinil show zero withdrawal symptoms and no tolerance. After a 7-week trial, a 2-week withdrawal was performed with no major issues, aside from a regression to previous ADHD behavior.
Keep an eye on the news. If Modafinil is approved, you should consult your doctor about Modafinil for your child with ADHD. And If it is indicated, the best thing to do would be to figure out what dosage your child needs. These clinical trials have tested a wide variety of doses, and have found 200-300mg doses once a day to be very effective. Nevertheless, some of the trials have experimented with extended release formulations and twice-daily dosage. It would not be wise to simply buy 200mg pills of Modafinil from a site such as Modup.net and start feeding them to your child without knowing if that amount is adequate or even safe for your child. Different weights and ages also require different doses. Your pediatrician will know best.
It’s promising to see Modafinil expand into this arena which so far has very few options to help worried parents and their afflicted children. A pill that has done wonders for adults may soon be revolutionizing the way we take care of our kids. Of course, the Modvigil blog will always be on top of the latest news, keeping you informed about the newest applications for Modafinil.