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.


  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. In study you’re discussing, it was actually only thought to be Stevens Johnsons Syndrome originally. If you research it now, you can see that they confirmed it was not and was in fact just a rash. FDA maintains their halt on approval, but I think it’s important to note that there wasn’t actually a life-threatening skin rash developed. I don’t know whether Modafinil is safe or not, or if it can cause Stevens Johnsons Syndrome, but it hasn’t been confirmed yet.

  6. I am 35, and I take Modafinil for my ADHD. Here’s my 2 cents on that – Modafinil really doesn’t seem to be as effective as the amphetamine/stimulants, but that’s OK; at least I don’t have those damned side effects like I get from the amphetamines. I experience no appetite decrease, no problems sleeping, and, what’s even better is that the chronic headaches I’ve had since I was a child have finally gone away. This, after using Modafinil for ADHD. Wierd, but true!. Just so, I would recommend taking a week or so off so you don’t have any withdrawl issues if you discontinue using Modafinil.

  7. The skin rash reaction in the news was not Stevens-Johnson syndrome.

    A simple google search will explain more.


    In December 2004, Cephalon submitted a supplemental new drug application (sNDA) to market Sparlon, a brand name of tablets containing higher doses of modafinil for the treatment of ADHD in children and adolescents ages 6 through 17. However, in March 2006, the FDA advisory committee voted 12 to 1 against approval, citing concerns about a number of reported cases of skin rash reactions in a 1000-patient trial, including one which was thought to be likely a case of Stevens-Johnson syndrome.

    Final rejection occurred in August 2006, although subsequent follow-up indicated that the skin rash reaction was not Stevens-Johnson syndrome.

    Cephalon then decided to discontinue development of the Sparlon product for use in pediatric cases, though there is potential for use in treating Adult ADHD. The high coincidence of day time sleepyness, sudden onset of day time sleep episodes (clinically indistinguishable from narcolepsy) in adult ADHD patients during inattentive-boring episodes of inactivity suggest a potential benefit of modafinil in ADHD patients suffering from episodic sleep disturbances.
    You should ask your physician to reconsider Modafinil for ADHD, as many doctors are prescribing it in spite of the FDA advisory committee vote.

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