Summary

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• Qelbree (viloxazine) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• ADHD-RS-5 Responders: Viloxazine demonstrated a significantly higher proportion of ADHD-RS-5 responders in pediatric patients aged 6-17 years compared to placebo (RR = 1.62; 95% CI = 1.36-1.93; P < .00001).
• CGI-I Score Improvement: A significantly greater number of pediatric patients treated with viloxazine showed improvement on the Clinical Global Impressions-Improvement (CGI-I) scale compared to placebo (RR = 1.53; 95% CI = 1.32-1.78; P < .00001).
• There was a higher proportion of patients experiencing at least one adverse event in the viloxazine group compared to placebo (RR = 1.52; 95% CI = 1.24-1.85; P < .0001). The incidence of somnolence was significantly higher in the viloxazine group (RR = 3.93; 95% CI = 2.11-7.31; P < .0001). The incidence of serious adverse events (SAEs) was higher in the viloxazine group (RR = 2.98; 95% CI = .67-13.3; P = .15), but this difference was not statistically significant.
• There is no population types or subgroups information available in the reviewed studies.