Long-Term Safety and Efficacy of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Open accessAbstract
Objective: Short-term, controlled studies of extended-release guanfacine (GXR), a selective α 2A -adrenoreceptor agonist, demonstrate efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms as monotherapy. This 2-year open-label study was conducted to further assess the long-term safety and efficacy of GXR. Methods: Study participants, aged 6–17 years with ADHD, had previously been exposed to GXR therapy alone or in combination with psychostimulants in one of two antecedent trials. In this study, doses were titrated to 1, 2, 3, or 4 mg/day of GXR alone or in combination with a psychostimulant. Safety and efficacy data collected at clinic visits over 24 months provided further evidence of the overall safety and efficacy of GXR for treating ADHD. Results: The majority of adverse events (AEs) were mild to moderate, and few patients discontinued the study because of an AE. Efficacy measures demonstrated significant improvement beginning in the first month and lasting through the end of the 24-month treatment period. Throughout the entire 2-year study, 202 subjects (77.1%) discontinued and 60 (22.9%) completed the study. Conclusions: Overall, these data support that GXR monotherapy is generally safe and effective for treating ADHD.
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Atomoxetine, extended-release guanfacine, and extended-release clonidine have demonstrated efficacy in reducing core symptoms among school-aged children and adolescents.
“Among nonstimulant medications, 1 selective norepinephrine reuptake inhibitor, atomoxetine,99,100 and 2 selective α-2 adrenergic agonists, extended-release guanfacine101,102 and extended-release clonidine,103 have also demonstrated efficacy in reducing core symptoms among school-aged children and adolescents”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [102]
Once-daily extended-release guanfacine has proven effective in both short-term and long-term studies.
“Recently, once-daily extended-release guanfacine has proven effective in both short-term [90,91] and long-term studies [92,93].”
From Advances in understanding and treating ADHD (2011) · cites this paper as [92]
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- Authors
- Sallee, F. R., Lyne, A., Wigal, T., & McGough, J. J.
- Affiliations
- University of Cincinnati (US)
- Shire (United Kingdom) (GB)
- University of California, Irvine (US)
- University of California, Los Angeles (US)
- Corresponding author
- Sallee, Floyd R.
- ORCID
- McGough, James J.
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2009-06
- Volume
- 19
- Issue
- 3
- Pages
- 215-226
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- OpenAlex
- W2082765847
- Cited by
- 306
- References
- 23
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2023: 7 · 2022: 3 · 2021: 4 · 2020: 165 · 2019: 7 · 2018: 5 · 2017: 6 · 2016: 8 · 2015: 5 · 2014: 24 · 2013: 15 · 2012: 16
- FWCI
- 10.69
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- Otsuka America
- Otsuka Pharmaceutical
- U.S. Food and Drug Administration
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- guanfacine extended release, attention deficit hyperactivity disorder, children and adolescents, long-term safety, long-term efficacy, adverse events, treatment discontinuation
- MeSH terms
- Adolescent, Adrenergic alpha-Agonists, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Guanfacine, Treatment Outcome
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