Extended-Release Clonidine Approved for Children with ADHD

The first treatment approved by the FDA as an adjunct to stimulants for treatment of attention-deficit/hyperactivity disorder

In 2009, the FDA approved extended-release guanfacine — an α₂-adrenergic agonist — for treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD; JW Pediatr Adolesc Med Oct 7 2009). Now, the FDA has approved another α₂-adrenergic agonist — extended-release clonidine hydrochloride (KAPVAY) — for use as monotherapy or as an adjunct to stimulants for treatment of ADHD in patients ages 6 to 17 years. KAPVAY is a nonstimulant, twice-daily oral treatment.

FDA approval was based on the findings of two randomized controlled trials that twice-daily extended-release clonidine either alone or with stimulants (methylphenidate or amphetamine) significantly decreased core ADHD symptoms (measured on a standardized parent rat…

Author

Martin T. Stein, MD

Disclosures

Consultant / Advisory boardPearson Neuroscience Advisory Board

Speaker’s bureauAmerican Academy of Pediatrics

RoyaltiesElsevier, Inc.

Editorial boardsJournal of Developmental and Behavioral Pediatrics

Martin T. Stein, MD

Disclosures

Consultant / Advisory boardPearson Neuroscience Advisory Board

Speaker’s bureauAmerican Academy of Pediatrics

RoyaltiesElsevier, Inc.

Editorial boardsJournal of Developmental and Behavioral Pediatrics