Modafinil for ADHD: FDA has serious concerns
Modafinil is a medication which is approved for treating sleep disorders in adults - such as narcolepsy. This medicine stimulates alertness, and was found to improve functioning of the frontal lobe of the brain, and it did so in a different way than the standard stimulants, i.e. methylphenidate (Concerta, Metadate, Ritalin) or amphetamines (Dexedrine, Adderall, Adderall XR).
Modafinil is also called: Provigil, Alertec, Vigicer and Modalert.
Early studies looking at use of this medication in children and teenagers with ADHD was promising. A full report on the early studies is here.
In March 2006, a serious side effect occured in a clinical trial. There were 933 children in a study of modafinil for ADHD, when one child developed a life threatening skin rash, called Stevens Johnsons Syndrome. The company believed that this side effect was not related to the medication, however the FDA refused to consider approval of modafinil for ADHD without extensive safety studies. It appears that the company involved, Cephalon, is abandoning research at this time. To read more on this issue, click here.
Even though modafinil is not officially approved for use in ADHD, it is still possible for a doctor to prescribe it for ADHD. This would be called ‘off label’ prescribing. If your child is on modafinil, or your doctor was suggesting it for treating ADHD, it is important to discuss this safety issue with your doctor.
=================================================
Written by Dr. Kenny Handelman - The ADHD Doctor
To find get a FREE special report on ADD/ADHD Medication, visit: Medication Mastery
==================================================
Email this post to a friend:
August 21st, 2006 at 1:26 am
I made reference to this in a comment submitted re your piece on Stratera. My supply of Modafinil was terminated due to the events you recite. I am appealing the ruling since the medication was prescribed for me for a sleep disorder not for my ADHD.
I have used Alertec for several years with no side effects and with benefit to both of my conditions. When Modafinil first came on the market it was well researched and promoted for both conditions. It was effective. I am now off it for about 5 months.
My Physician who monitors my ADHD is hopeful that by increasing the dosage of Sttratera, the lack of the Alertec will be negligible. The results are not yet clear. I do find I miss the stimulation provided by the Modafinil. To cease the renewed research on this drug is, I feel, short-sighted.
August 23rd, 2006 at 6:06 pm
Dear Doctor,
FDA concerns for ADHD meds
In recent days The media has reported FDA concerns about various stimulants. A while back - Adderral was in the news in Canada.
Those who are anti - medication refer to these reports.
Could you please comment on how parents/doctors should be relating to these reports
Yours Allan
August 16th, 2008 at 3:22 pm
Hello Doctor Handelman. Three quick questions.I was wondering do you have any experience in prescribing Alertec/Modafinil any of your patients for ADHD? And if so can you tell us if it is helping them.? Also if you know what the typical Canadian Market price is for it? Thank you for your time.
September 1st, 2008 at 9:31 pm
That’s too bad that it didn’t work out. I personally use adderall for my attention problems, but I do think that modafinil might be less likely to be neurotoxic. I think in the future, we will increasingly see new neurotechnologies such as transcranial magnetic stimulation to improve brain disorders. I even think that TMS may eventually be used for ADD and ADHD in the future.