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In Children and Adolescents (Ages 6-17) With Attention Deficit Hyperactivity Disorder (ADHD), How Does Viloxazine Extended-Release (ER) Compare with Placebo or Other ADHD Medications in Terms of Improving ADHD Symptoms, Adverse Events and Treatment Discontinuation Rates? A Systematic Review

Published online by Cambridge University Press:  20 June 2025

Khushboo Kansal
Affiliation:
1Nottinghamshire NHS Trust, Nottingham, United Kingdom
Betsy Marina Babu
Affiliation:
2London and KSS school of Psychiatry, London, United Kingdom
Gaurav Uppal
Affiliation:
3Satyam Hospital, Ludhiana, India
Nadia Liaqat
Affiliation:
4East London NHS, London, United Kingdom
Asha Dhandapani
Affiliation:
5BCUHB, Wrexham, United Kingdom
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Abstract

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Aims: In this systematic review, the effectiveness and safety of viloxazine ER in the treatment of ADHD in children and adolescents aged between 6–17 years will be assessed.

Methods: This review identified articles through a systematic approach using PubMed, EMBASE, and the Cochrane Library. Randomized controlled trials with viloxazine ER in an active comparator condition versus placebo or other stimulant/non-stimulant ADHD drugs were included.

The first set of outcomes for assessing efficacy was a decrease in the severity of ADHD symptoms as measured by the ADHD-RS-5 and CGI-I scales. Safety outcomes comprised comparability in the rates of adverse events and treatment discontinuation rates.

Results: A meta-analysis showed that viloxazine ER is effective in managing ADHD symptoms compared with placebo at 10–12 weeks. Very few side effects were reported with this medication and those reported were mostly mild to moderate in nature. Mild side effects were noted to be decreased appetite, somnolence, and headache. The rates of treatment disappearance were similar compared with other oral ADHD drugs.

Conclusion: The research implies that viloxazine ER may be useful to paediatric patients with ADHD as a new treatment approach. We hypothesize that its profile of being an NRI and 5-HT2B antagonist may be beneficial for patients who have not shown sufficient improvement with more common treatments. The use of once daily dosing of the extended release formulation may enhance compliance compared with drugs taken more than once per day.

In a general manner, viloxazine ER seems to be a safe and efficacious therapy in children and adolescents affected by ADHD. Because it has a unique mechanism of action and can be taken once daily, it complements other ADHD medications well. More prospective, multicentre trials of longer duration are, therefore, required to determine the success and risks of the technique in the long run.

Type
Research
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Royal College of Psychiatrists

Footnotes

Abstracts were reviewed by the RCPsych Academic Faculty rather than by the standard BJPsych Open peer review process and should not be quoted as peer-reviewed by BJPsych Open in any subsequent publication.

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