Modafinil for ADHD: FDA has serious concernsBy
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.