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Viloxazine for attention-deficit hyperactivity disorder: a new formulation for a new indication

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Abstract

Viloxazine (SPN-812), an age-old antidepressant, has recently been approved by the US FDA for the treatment of attention-deficit hyperactivity disorder (ADHD) in children aged 6–17 years, at a dose range of 100–400 mg/day. Viloxazine acts primarily by norepinephrine reuptake inhibition and may also modulate the serotonergic system. The efficacy of viloxazine for the treatment of ADHD in children aged 6–17 years has been demonstrated in a series of short-term clinical trials. The most common adverse events include somnolence and gastrointestinal upset, while the FDA has issued a black-box warning regarding suicidal ideation or behavior. This article summarizes the information regarding viloxazine based on previously published narrative reviews, preclinical studies, and blinded controlled clinical trials.

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Correspondence to Alok Singh.

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Mahesh Kumar Balasundaram and Alok Singh have no conflicts of interest to declare.

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Balasundaram, M.K., Singh, A. Viloxazine for attention-deficit hyperactivity disorder: a new formulation for a new indication. Drugs Ther Perspect 38, 77–83 (2022). https://doi.org/10.1007/s40267-022-00892-z

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