Modafinil and ADD

The Washington Post has just reported that the FDA has turned an application from the Pharmaceutical Company Cephalon to have modafinil approved for use in children with ADD, because of worries about a potentially serious skin reaction called Stevens-Johnson syndrome .

This is a real shame: we need more options for treating children and adults with ADD, and although I am a huge proponent of non-pharmacological methods of treatment, the fact is that a lot of people simply do not respond to the methods that we currently have available, and some do not even respond to the medications that are available.

Modafinil had looked very promising: in December 1998 the FDA approved modafinil under the brand name Provigil for treating adults with sleepiness associated with narcolepsy. Its main mechanism of action is to inhibit the reuptake of dopamine in key regions of the brain, effectively increasing the amount of dopamine available. It has been used off-label for excessive daytime sleepiness and last year a study form the University of Pennsylvania indicated that it might help some cocaine addicts fight their cravings. It is an open secret that a great many students and academics have been using it for years to enable them to study and work longer. I remember an article from someone who was due to lecture in India, immediately after his arrival from the United States. He admitted to taking modafinil to help him get through the ordeal.

The application to use modafinil in ADD is not dead. The FDA has said that they want a 3000 patients study to assess the risk of Stevens-Johnson syndrome, and the company will discuss that with them. But it will inevitably mean delays.

Technorati tags: ADD, ADHD Modafinil

Comments

[Kyle Varner]

I was on Provigil for awhile, and found that it was a great boon to my life.

[Richard Petty]

You and thousands of others too. Modafinil is a remarkably interesting medicine and this nasty side effect is a dreadful shame.

There was only one severe skin reaction out of 900 patients, but when I say severe, by all accounts it really was. So it is right for the FDA and the company to play safe, and I really do hope that future research will give us a clear estimate of the risks and benefits of the medicine.