Which psychostimulants are FDA approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children?

Updated: Nov 20, 2018
  • Author: Maggie A Wilkes, MD; Chief Editor: Caroly Pataki, MD  more...
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Answer

In May 2013, the FDA approved the stimulant lisdexamfetamine dimesylate (Vyvanse, Shire Plsc) as a maintenance treatment in children and adolescents (aged 6 years and older) with ADHD. The drug was previously approved as a maintenance treatment only in adults. [14]

In June 2017, the FDA approved 2 new ADHD medications, Contempla XR-ODT and Mydayis. Contempla XR-ODT is approved for the treatment of ADHD in children and adolescents between 6 and 17 years of age. It is an oral disintegrating tablet form of extended-release methylphenidate, given once every morning, and is available as a 8.6 mg, 17.3 mg, and 25.9 mg tablet. [15]  Mydayis is also approved for the treatment of ADHD in adolescents and adults aged 13 years or older. It is an extended-release capsule of mixed amphetamine salts administered each morning. It is available as a 12.5 mg, 25 mg, 37.5mg, and 50 mg capsule. [16]

Approval for lisdexamfetamine dimesylate was based on a 32-week trial designed to evaluate efficacy of the drug in 276 children and adolescents aged 6-17 years. Patients received dosages of 30 mg/day, 50 mg/day, or 70mg/day. Treatment failures at the end point of the 6-week withdrawal period occurred at a significantly lower rate in the drug group (15.8%) than in the placebo group (67.5%). This evidence strongly suggested that patients treated with the drug maintain greater ADHD symptom control.


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