ADHD Questions
Why isn't Modafinil approved for ADHD?
Charles Li, MD
July 19, 2023
🙅♂️
While modafinil is approved as a treatment for narcolepsy, the FDA has not approved it to treat ADHD in children and teenagers.
💊
Studies have shown that modafinil can reduce ADHD symptoms.
⚠️
However, it can potentially cause a rare but serious skin side effect, which led to an FDA panel recommending against its approval as an ADHD treatment.
Modafinil is a medication currently approved to treat narcolepsy. It's similar to stimulant medications used to treat ADHD, such as Ritalin and Adderall.
“
Modafinil is a novel stimulant-like compound that is currently approved for the treatment of narcolepsy, and has been widely studied as a potential treatment for ADHD. Its mechanism of action is complex with evidence of effects across a wide range of neurotransmitter systems, including catecholamines, serotonin, glutamate, GABA, and orexin
Modafinil as an ADHD treatment
Studies on modafinil in children have found that it can effectively reduce ADHD symptoms. A comparison study found that modafinil reduced ADHD symptoms as much as Ritalin:
What are the side effects of modafinil?
In clinical trials of modafinil among children with ADHD, the data has shown that modafinil's side effects are mostly mild. For most patients, modafinil is likely to be safe.
The top side effects in one trial were insomnia, headache, and decreased appetite:
Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study
These are similar to side effects in Ritalin or Adderall. One study comparing Ritalin and modafinil found similar rates of side effects between the two medications:
Modafinil as a treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial
Why didn't the FDA approve modafinil?
While the FDA did note that modafinil may be effective in reducing ADHD symptoms, they were concerned about the potential of a rare but serious skin side effect:
“
It was efficacious in fairly large studies of attention deficit hyperactivity disorder (ADHD) in children and adolescents, and was as efficacious as methylphenidate in a small trial, but has not been approved by the FDA, in part because of its serious dermatological toxicity. In a trial of 21 non-concurrent subjects, with 2-week treatment periods, modafinil was as effective as dexamfetamine in adult ADHD.
Most of those who took modafinil were unaffected by this rare side effect. However, for those who are affected, this was a serious and debilitating potential side effect:
“
Dr. Glen Manheim(ph), an FDA scientist, described children who developed severe skin rashes after taking Modafinil.
One subject had peeling and blistering over the entire body, with lips and urinary tract involvement. The drug was stopped, but the rash progressed to involve peeling, blistering, mucosal involvement, over days.
Key takeaways
To be approved, medication needs to be both safe and effective. The FDA balances data on this to ensure that the benefits of a medication for a specific condition outweigh the risks.
While there's evidence that modafinil may be effective, the benefits of modafinil as a treatment for ADHD in children and teenagers have not been shown to outweigh its risks.