Which long-acting medications are FDA-approved for treatment of attention deficit hyperactivity disorder (ADHD)?

Updated: Oct 01, 2019
  • Author: Stephen Soreff, MD; Chief Editor: Glen L Xiong, MD  more...
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Answer

In 2015, the FDA approved a once-daily extended-release oral liquid for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older. [49]  In the same year, the FDA approved a chewable tablet form of extended-release methylphenidate, to be sold as QuilliChew ER, for treatment of ADHD in patients aged 6 years or older. The tablet comes in strengths of 20, 30, and 40 mg and are scored so they can be split easily. The product is to be taken once daily in the morning. [50] In June 2017, the FDA approved 2 new ADHD medications, Cotempla XR-ODT and Mydayis. Cotempla XR-ODT is approved for the treatment of ADHD in children and adolescents aged 6-17 years. It is an oral disintegrating tablet form of extended-release methylphenidate, given once every morning, and is available as an 8.6 mg, 17.3 mg, and 25.9 mg tablet. [51] 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.

The first bedtime methylphenidate (Jornay PM) was approved by the FDA in 2018. It is indicated for ADHD patients aged 6 years or older. It is administered at 8 PM, although the administration time may be adjusted between 6:30 PM and 9:30 PM to optimize tolerability and efficacy the next morning and throughout the day. The capsule contains 2 functional film coatings that act synergistically to achieve a unique pharmacokinetic profile. The first layer delays the initial release of drug for up to 10 hours, and the second layer helps to control the rate of release of the active pharmaceutical ingredient throughout the day. Compared with placebo, Jornay PM achieved significant improvements in ADHD symptoms as measured by the ADHD rating scale IV (p = 0.002) and the parent rating of evening and morning behavior (revised) scale (p < 0.001). [52]


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