{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:23:18Z","timestamp":1777494198218,"version":"3.51.4"},"reference-count":47,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>Viloxazine extended-release (VLX-ER) is effective as monotherapy for attention-deficit\/hyperactivity disorder (ADHD), and is often tried as an add-on treatment when psychostimulant therapy fails to provide an adequate treatment response. This phase 4, open-label study evaluated safety, tolerability, and efficacy of VLX-ER with optimized psychostimulants in pediatric participants with ADHD. Morning versus evening VLX-ER use was also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Children and adolescents (6\u201317 years) experiencing inadequate psychostimulant response (investigator-assessed ADHD Rating Scale-5 [ADHD-RS-5] score \u226524 and Clinical Global Impression-Severity of Illness [CGI-S] scores \u22653) during a 4-week screening period received flexibly-dosed VLX-ER, taken once daily in the morning (weeks 14) or evening (weeks 5\u20138), concomitantly with a psychostimulant. Safety (primary outcome) and efficacy were evaluated relative to baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Fifty-six participants (26 children; 30 adolescents) enrolled, and 48 (85.7%) completed the study. Combination therapy was well tolerated, with only two participants (3.6%) withdrawing due to adverse events (AEs). The most commonly reported AEs were headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%). Mean \u00b1 standard deviation investigator-assessed ADHD-RS-5 scores (baseline: 37.2 \u00b1 8.4) improved progressively by \u221213.5 \u00b1 9.7 points at week 4 and \u221218.2 \u00b1 10.0 points at week 8 (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      &lt; 0.0001 each). Likewise, CGI-S scores (baseline: 4.4 \u00b1 0.6) improved by \u22120.9 \u00b1 0.9 at week 4 and \u22121.4 \u00b1 1.1 at week 8 (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      &lt; 0.0001 each). Parent-assessed scales, including ratings of morning and evening ADHD behaviors and sleep disturbances, showed significant improvement relative to baseline regardless of morning (week 4) or evening (week 8) VLX-ER dosing.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Combined treatment with VLX-ER and psychostimulant therapy showed acceptable safety and tolerability, with improvement in morning and evening ADHD behaviors and sleep disturbances relative to stimulant monotherapy. Timing of VLX-ER administration (morning or evening) did not appear to affect safety, drug response, or sleep improvement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2024.0138","type":"journal-article","created":{"date-parts":[[2025,2,27]],"date-time":"2025-02-27T12:13:51Z","timestamp":1740658431000},"page":"155-166","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit\/Hyperactivity Disorder: A Phase 4, Open-Label Trial"],"prefix":"10.1177","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5782-7891","authenticated-orcid":false,"given":"Ann","family":"Childress","sequence":"first","affiliation":[{"name":"Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kobby","family":"Asubonteng","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georgette","family":"Cox","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jami","family":"Earnest","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberley","family":"Hayman","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilmiya","family":"Yarullina","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Rubin","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,4,9]]},"reference":[{"key":"e_1_3_6_2_1","volume-title":"Diagnostic and statistical manual of mental disorders: DSM-5","author":"APA","year":"2013","unstructured":"APA. 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