ADHD Questions
Can I treat ADHD with modafinil?
Charles Li, MD
July 19, 2023
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Studies on modafinil in children and teenagers have shown that it can reduce ADHD symptoms and improve well-being.
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While most side-effects are mild, there have been rare but serious side effects seen in children.
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The FDA has noted that modafinil may be effective in reducing ADHD symptoms, but it has not approved it for ADHD due to its risks in children.
Modafinil is a treatment approved for narcolepsy and shift-work disorder. It is a stimulant similar to Adderall and Ritalin.
Studies show that modafinil can potentially reduce ADHD symptoms in children and teenagers.
Currently, modafinil is not approved as a treatment for ADHD in adults or children, though it is approved and available as a drug. Some physicians may prescribe it as an off-label treatment for ADHD.
What is an off-label drug?
In a meeting regarding approval of modafinil as an ADHD treatment, FDA decided against approval partly due to their concerns regarding a rare skin side effect.
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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.
Is modafinil effective as an ADHD treatment?
The FDA meeting that recommended the rejection of modafinil as an ADHD treatment did agree that modafinil may be an effective treatment for ADHD in children and teenagers:
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A Food and Drug Administration advisory committee said modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.
Randomized trials on modafinil and ADHD have shown that it can reduce ADHD symptoms. For example, one study below found that modafinil reduces ADHD symptoms while improving overall health and well-being:
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
Another study found that modafinil may be nearly as effective as Ritalin in reducing ADHD symptoms:
Modafinil as a treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial
Key Takeaways
Studies on modafinil have shown evidence that it can reduce ADHD symptoms, similar to Adderall or Ritalin. However, due to rare but severe side effects, it is not currently approved as an ADHD treatment.
Approval of any medication or indication requires a balance of effectiveness and safety. While modafinil may be effective in reducing ADHD symptoms, there's not enough evidence showing that the risks of modafinil outweigh its benefits.