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July 21, 2021
Viloxazine (Qelbree): A New Non-Stimulant Medication for Pediatric ADHD: Viloxazine is a norepinephrine reuptake inhibitor (NRI) and serotonin modulator that was FDA-approved in 2021 for treatment of pediatric attention deficit-hyperactivity disorder (ADHD). Short-term efficacy and safety were established via four phase 3, randomized, placebo-controlled trials in children ages 6–17 years in doses from 100–400 mg once daily. Compared to other non-stimulant medications for pediatric ADHD, viloxazine may provide a faster onset of symptom improvement, with clinical trials showing significant benefits as early as one week after starting therapy. The most common side effects of viloxazine include somnolence, fatigue, gastrointestinal upset, insomnia, and irritability. Patients should be monitored for suicidality as well as increases in blood pressure and heart rate. There is currently no evidence that viloxazine is more effective than stimulants (which remain first-line therapy for ADHD) or the non-stimulant atomoxetine. Guidelines will likely place viloxazine with other non-stimulant medications as a second-line therapy for pediatric ADHD.
Upon completion of the chapter, the reader will be able to:
Explain accepted criteria necessary for the diagnosis of attention-deficit/hyperactivity disorder (ADHD).
Recommend a therapeutic plan, including drug selection, initial doses, dosage forms, and monitoring parameters, for a patient with ADHD.
Differentiate among the available pharmacologic agents used for ADHD with respect to pharmacology and pharmaceutical formulation.
Recommend second-line and/or adjunctive agents that can be effective alternatives in the treatment of ADHD when stimulant therapy is less than adequate.
Address potential cost–benefit issues associated with pharmacotherapy of ADHD.
Recommend strategies for minimizing adverse effects of ADHD medications.
Attention-deficit/hyperactivity disorder (ADHD) is characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity. It can have a severe impact on a patient’s ability to function in both academic and social environments. Early diagnosis and appropriate treatment are essential to compensate for areas of deficit.
EPIDEMIOLOGY AND ETIOLOGY
This disorder usually begins in young children and must occur before 12 years of age to meet current diagnostic criteria. In the United States, ADHD is the most common neurobehavioral disorder that affects children.1 ADHD has been diagnosed in approximately 11% of school-aged children.2 ADHD occurs more than twice as often in school-aged boys than girls.3
Although ADHD generally is considered a childhood disorder, symptoms can persist into adolescence and adulthood. The prevalence of adult ADHD is estimated to be 2.5%; majority of adults with ADHD have symptoms that manifested in childhood.3,4 Furthermore, problems associated with ADHD (eg, social, marital, academic, career, anxiety, depression, smoking, and substance abuse problems) increase with the transition of patients into adulthood. Untreated adults with ADHD have high rates of psychopathology, substance abuse, and social and occupational dysfunction.