Viloxazine extended-release capsules as an emerging treatment for attention-deficit/hyperactivity disorder in children and adolescents
Open accessAbstract
Introduction Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention and/or hyperactivity and impulsivity. Viloxazine extended-release (ER) capsules (Qelbree®) is a US Food and Drug Administration-approved nonstimulant treatment option for children, adolescents, and adults with ADHD. Areas covered This review manuscript summarizes the neurobiology of ADHD and currently available treatment options before discussing viloxazine pharmacology, efficacy, safety, and tolerability data from phase II and III trials in children and adolescents (6-17 years old). Viloxazine clinical efficacy has also been further demonstrated by post hoc analyses of pediatric clinical trial results. Expert opinion Current stimulant and nonstimulant treatments for ADHD may be suboptimal given low response rates and that tolerability issues are frequently experienced. Preclinical and clinical evidence has implicated both the role of catecholamine and serotonin signaling in the pathophysiology of ADHD and the pharmacologic effect of viloxazine on these critical neurotransmitter systems. With a relatively rapid onset of action, sustained symptom improvement, and clinical benefit in ADHD-associated impairments (functional and social), viloxazine ER represents a novel and emerging ADHD treatment option.
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Viloxazine, approved for ADHD by the US Food and Drug Administration in 2021, is not available in Sweden.
“For instance, viloxazine, which was approved for ADHD by the US Food and Drug Administration in 2021,23 is not available in Sweden.”
Cites
Wolraich, M. L., Hagan, J. F., Allan, C., Chan, E., Davison, D., Earls, M., Evans, S. W., Flinn, S. K., Froehlich, T., Frost, J., et al. (2019) · Pediatrics · doi:10.1542/peds.2019-2528 · Cited by 1,410 · see citing works
Danielson, M. L., Bitsko, R. H., Ghandour, R. M., Holbrook, J. R., Kogan, M. D., & Blumberg, S. J. (2018) · Journal of Clinical Child & Adolescent Psychology · doi:10.1080/15374416.2017.1417860 · Cited by 1,181 · see citing works
Attention-deficit hyperactivity disorder
Posner, J., Polanczyk, G. V., & Sonuga-Barke, E. (2020) · The Lancet · doi:10.1016/s0140-6736(19)33004-1 · Cited by 835 · see citing works
del Campo, N., Chamberlain, S. R., Sahakian, B. J., & Robbins, T. W. (2011) · Biological Psychiatry · doi:10.1016/j.biopsych.2011.02.036 · Cited by 685 · see citing works
Faraone, S. V. (2018) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2018.02.001 · Cited by 631 · see citing works
Hannestad, J., Gallezot, J.-D., Planeta-Wilson, B., Lin, S.-F., Williams, W. A., van Dyck, C. H., Malison, R. T., Carson, R. E., & Ding, Y.-S. (2010) · Biological Psychiatry · doi:10.1016/j.biopsych.2010.06.017 · Cited by 236 · see citing works
Caye, A., Spadini, A. V., Karam, R. G., Grevet, E. H., Rovaris, D. L., Bau, C. H. D., Rohde, L. A., & Kieling, C. (2016) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-016-0831-8 · Cited by 210 · see citing works
Hodgkins, P., Shaw, M., Coghill, D., & Hechtman, L. (2012) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-012-0286-5 · Cited by 147 · see citing works
Advances in understanding and treating ADHD
Antshel, K. M., Hargrave, T. M., Simonescu, M., Kaul, P., Hendricks, K., & Faraone, S. V. (2011) · BMC Medicine · doi:10.1186/1741-7015-9-72 · Cited by 140 · see citing works
Yu, C., Garcia-Olivares, J., Candler, S., Schwabe, S., & Maletic, V. (2020) · Journal of Experimental Pharmacology · doi:10.2147/jep.s256586 · Cited by 96 · see citing works
Self-citationQuintero, J., Gutiérrez-Casares, J. R., & Álamo, C. (2022) · Neurology and Therapy · doi:10.1007/s40120-022-00392-2 · Cited by 70 · see citing works
Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status
Findling, R. L., Candler, S. A., Nasser, A. F., Schwabe, S., Yu, C., Garcia-Olivares, J., O’Neal, W., & Newcorn, J. H. (2021) · CNS Drugs · doi:10.1007/s40263-021-00825-w · Cited by 55 · see citing works
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Garcia-Argibay, M., Chang, Z., Brikell, I., Kuja-Halkola, R., D'Onofrio, B. M., Lichtenstein, P., Newcorn, J. H., Faraone, S. V., Larsson, H., & Cortese, S. (2025) · The Lancet Psychiatry · doi:10.1016/s2215-0366(24)00396-1 · Cited by 31 · see citing works
- Authors
- Maletic, V., Mattingly, G. W., & Earnest, J.
- Affiliations
- University of South Carolina (US)
- Washington University in St. Louis (US)
- Supernus Pharmaceuticals (United States) (US)
- Corresponding author
- Maletic, Vladimir
- Venue
- Expert Review of Neurotherapeutics
- Publisher
- Informa UK Limited
- Published
- 2024-03-19
- Volume
- 24
- Issue
- 5
- Pages
- 443-455
- ISSN
- 1473-7175 (ISSN-L)
- 1744-8360
- OpenAlex
- W4392949436
- Cited by
- 2
- References
- 12
- Citations by year
- 2025: 2
- FWCI
- 0.16
- Type
- journal article
- Language
- en
- Open access
- hybrid
- dx.doi.org
- Licence
- Locations
- Expert Review of Neurotherapeutics (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Supernus Pharmaceuticals
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- viloxazine, extended-release capsules, attention deficit hyperactivity disorder, children with ADHD, catecholamine signaling, serotonin signaling, ADHD pathophysiology, drug safety and efficacy, tolerability
- MeSH terms
- Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Humans, Viloxazine, Treatment Outcome
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