Long-term effectiveness of lisdexamfetamine for the treatment of attention deficit hyperactivity disorder and binge eating disorder
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02484| Published on: 2026-05-05
DOI:
https://doi.org/10.22239/2317-269X.02484Keywords:
Lisdexamfetamine Dimesylate, Attention Deficit Disorder with Hyperactivity, Binge-eating Disorder, ReviewAbstract
Introduction: Lisdexamfetamine (LDX) is a medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, the medication is rapidly absorbed by the gastrointestinal tract and converted into D-amphetamine covalently bound to the natural amino acid L-lysine, responsible for the drug’s activity. Objective: To evaluate the long-term effectiveness of Lisdexamfetamine for treating Attention Deficit Hyperactivity Disorder and Binge Eating Disorder. Method: A search was conducted in PubMed, Embase, Web of Science, and Cochrane using descriptors and their respective synonyms to identify the long-term efficacy and safety of LDX in individuals with ADHD and BED. Interventional and controlled group studies with a follow-up period of more than 5 weeks were included. Results: 30 studies were included. Regarding the population, the effects of LDX were investigated in individuals aged 5-55 years, with the longest follow-up being 108 weeks. Overall, the literature indicates a significant reduction in symptoms within the first 5-6 weeks of treatment, stabilizing in the following weeks. For ADHD, studies up to 108 weeks reported mean reductions of –25.8 points on the ADHD-RS-IV (95% CI –27.0 to –24.5), improvement in CGI-I ratings from 42.3% to 89.1%, and maintenance-of-response rates above 75% in adults after 12 months. For BED, studies with up to 52 weeks of follow-up showed that 89.8% of participants experienced clinical improvement on the CGI-I, with significant reductions in weekly binge-eating days (least-squares mean differences up to –1.66; p < 0.001) and a mean improvement of –1.95 points on the EDE-Q. Conclusions: The findings suggest that LDX shows promising long-term results for both health conditions. However, healthcare professional follow-up is necessary due to the drug’s adverse events.
Downloads
Author Biographies
-
Maíra Catharina Ramos, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil | Programa de Pós-graduação em Saúde Coletiva, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil
-
Viviane Cássia Pereira, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil
-
Flávia Tavares Silva Elias, Programa de Evidências para Políticas e Tecnologias de Saúde, Fundação Oswaldo Cruz (Fiocruz), Brasília, DF, Brasil
References
1. Elia J, Easley C, Kirkpatrick P. Lisdexamfetamine dimesylate. Nat Rev Drug Discov. 2007;6(5):343-4.https://doi.org/10.1038/nrd2315
2. Ministério da Saúde (BR). Portaria conjunta Nº 14, de 29 de julho de 2022. Aprova o protocolo clínico e diretrizes terapêuticas do transtorno do déficit de atenção com hiperatividade.Diário Oficial União. 30 jul 2022.
3. Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med.2014;126(5):17-24.
4. Fava DC, Barbosa ACC, Portes JRM, Ornelas O. Transtorno de déficit de atenção/hiperatividade. In: Moreno AL, Melo W, editor. Casos clínicos em saúde mental: diagnóstico e indicação de tratamentos baseados em evidências. Porto Alegre: Artmed; 2022. p. 232.
5. Davis HA, Graham AK, Wildes JE. Overview of binge eating disorder. Curr Cardiovasc Risk Rep. 2020;14(12).https://doi.org/10.1007/s12170-020-00664-2
6. Kjeldbjerg ML, Clausen L. Prevalence of binge-eating disorder among children and adolescents: a systematic review and meta-analysis. Eur Child Adolesc Psych. 2023;32(4):549-74.https://doi.org/10.1007/s00787-021-01850-2
7. McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine dimesylate for adults with moderate to severe binge eating disorder: results of two pivotal phase 3 randomized controlled trials. Neuropsychopharmacology. 2016;41(5):1251-60.https://doi.org/10.1038/npp.2015.275
8. Yee KS, Pokrzywinski R, Hareendran A, Shaffer S, Sheehan D V. Evaluating functional disability in clinical trials of lisdexamfetamine dimesylate in binge eating disorder using the Sheehan Disability Scale. Int J Methods Psychiatr Res. 2021;30(1):1-13.https://doi.org/10.1002/mpr.1849
9. Banaschewski T, Johnson M, Nagy P, Otero IH, Soutullo CA, Yan B et al. Growth and puberty in a 2-year open-label study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2018;32(5):455-67.https://doi.org/10.1007/s40263-018-0514-8
10. Childress AC, Lloyd E, Johnson SAJ, Gunawardhana L, Arnold V. A long-term, open-label safety and tolerability study of lisdexamfetamine dimesylate in children aged 4-5 years with attention-deficit/hyperactivity disorder.J Child Adolesc Psychoph. 2022;32(2):98-106.https://doi.org/10.1089/cap.2021.0138
11. Sheehan DV, Gasior M, McElroy SL, Radewonuk J, Herman BK, Hudson J. Effects of lisdexamfetamine dimesylate on functional impairment measured on the sheehan disability scale in adults with moderate-to-severe binge eating disorder: results from two randomized, placebo-controlled trials.Innov Clin Neurosci. 2018;15(5-6):22-9.
12. Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B et al. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014;28(11):1059-69.https://doi.org/10.1007/s40263-014-0188-9
13. McElroy SL, Mitchell JE, Wilfley D, Gasior M, Ferreira-Cornwell MC, McKay M et al. Lisdexamfetamine dimesylate effects on binge eating behaviour and obsessive-compulsive and impulsive features in adults with binge eating disorder. Eur Eat Disord Rev. 2016;24(3):223-31.https://doi.org/10.1002/erv.2418
14. Findling RL, Childress AC, Krishnan S, McGough JJ. Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. CNS Spectr. 2008;13(7):614-20.https://doi.org/10.1017/s1092852900016898
15. Coghill DR, Banaschewski T, Nagy P, Otero IH, Soutullo C, Yan B et al. Long-term safety and efficacy of lisdexamfetamine dimesylate in children and adolescents with ADHD: a phase IV, 2-year, openlabel study in Europe. CNS Drugs. 2017;31(7):625-38.https://doi.org/10.1007/s40263-017-0443-y
16. Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P et al. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014;28(12):1191-203.https://doi.org/10.1007/s40263-014-0193-z
17. Adler LA, Lynch LR, Shaw DM, Wallace SP, O’Donnell KE, Ciranni MA et al. Effectiveness and duration of effect of open-label lisdexamfetamine dimesylate in adults with ADHD. J Atten Disord. 2017;21(2):149-57.https://doi.org/10.1177/1087054713485421
18. Guerdjikova AI, Mori N, Blom TJ, Keck PE Jr, Williams SL, Welge JA et al. Lisdexamfetamine dimesylate in binge eating disorder: a placebo controlled trial. Hum Psychopharmacol. 2016;31(5):382-91.https://doi.org/10.1002/hup.2547
19. Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC et al. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2013;23(1):11-21.https://doi.org/10.1089/cap.2011.0088
20. Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study.J Child Adolesc Psychopharmacol. 2009;19(6):649-62.https://doi.org/10.1089/cap.2008.0165
21. Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive function of children and adolescents with attention-deficit/hyperactivity disorder in a 2-year open-label study of lisdexamfetamine dimesylate. CNS Drugs. 2018;32(1):85-95.https://doi.org/10.1007/s40263-017-0487-z
22. Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of lisdexamfetamine in adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA psychiatry.2017;74(9):903-10. https://doi.org/10.1001/jamapsychiatry.2017.1889
23. Kornstein SG, Bliss C, Kando J, Madhoo M. Clinical characteristics and treatment response to lisdexamfetamine dimesylate versus placebo in adults with binge eating disorder: analysis by gender and age. J Clin Psychiatry. 2019;80(2).
24. Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A et al. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013;23(10):1208-18.https://doi.org/10.1016/j.euroneuro.2012.11.012
25. Citrome L, Kando JC, Bliss C. Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies. Neuropsychiatr Dis Treat. 2018;14:537-46.https://doi.org/10.2147/NDT.S158395
26. Childress AC, Lloyd E, Jacobsen L, Gunawardhana L, Johnson SA Jr, Findling RL. Efficacy and safety of lisdexamfetamine in preschool children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2022;61(12):1423-34.https://doi.org/10.1016/j.jaac.2022.03.034
27. Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH et al. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry.2014;23(2):61-8.https://doi.org/10.1007/s00787-013-0421-y
28. Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS et al. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry.2014;53(6):647-57.https://doi.org/10.1016/j.jaac.2014.01.017
29. Mattingly GW, Weisler RH, Young J, Adeyi B, Dirks B, Babcock T et al. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. BMC Psychiatry. 2013;13:1-12. https://doi.org/10.1186/1471-244X-13-39
30. Setyawan J, Yang HB, Cheng D, Cai XP, Signorovitch J, Xie JP et al. Developing a risk score to guide individualized treatment selection in attention deficit/hyperactivity disorder. Value Health.2015;18(6):824-31. https://doi.org/10.1016/j.jval.2015.06.005
31. McElroy SL, Hudson JI, Gasior M, Herman BK, Radewonuk J, Wilfley D et al. Time course of the effects of lisdexamfetamine dimesylate in two phase 3, randomized, double-blind, placebo-controlled trials in adults with binge-eating disorder. Int J Eat Disord.2017;50(8):884-92. https://doi.org/10.1002/eat.22722
32. Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B et al. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attentiondeficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.CNS Drugs.2013;27(12):1081-92. https://doi.org/10.1007/s40263-013-0104-8
33. Ichikawa H, Miyajima T, Yamashita Y, Fujiwara M, Fukushi A, Saito K. Long-term study of lisdexamfetamine dimesylate in Japanese children and adolescents with attention-deficit/hyperactivity disorder. Neuropsychopharmacol Rep. 2020;40(1):52-62.https://doi.org/10.1002/npr2.12091
34. Hansen MV, Darling L, Holst H. Safety and tolerability of lisdexamfetamine: a retrospective cohort study.CNS Drugs. 2015;29(5):415-23.https://doi.org/10.1007/s40263-015-0246-y
35. Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med. 2014;126(5):17-24.https://doi.org/10.3810/pgm.2014.09.2796
36. Gasior M, Hudson J, Quintero J, Ferreira-Cornwell MC, Radewonuk J, McElroy SL. A phase 3, multicenter, open-label, 12-month extension safety and tolerability trial of lisdexamfetamine dimesylate in adults with binge eating disorder. J Clin Psychopharmacol. 2017;37(3):315-22.https://doi.org/10.1097/JCP.0000000000000702
37. Guerdjikova AI, Mori N, Blom TJ, Keck PE, Williams SL, Welge JA et al. Lisdexamfetamine dimesylate in binge eating disorder: a placebo controlled trial.Hum Psychopharmacol Exp.2016;31(5):382–91.https://doi.org/10.1002/hup.2547
38. Stuhec M, Lukic P, Locatelli I, Lukić P, Locatelli I, Lukic P et al. Efficacy, acceptability, and tolerability of lisdexamfetamine, mixed amphetamine salts, methylphenidate, and modafinil in the treatment of attention-deficit hyperactivity disorder in adults: a systematic review and metaanalysis.Ann Pharmacother.2019;53(2):121-33.https://doi.org/10.1177/ 1060028018795703
39. Maneeton N, Maneeton B, Suttajit S, Reungyos J, Srisurapanont M, Martin SD. Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD. Drug Des Dev Ther. 2014;8:1385-93.https://doi.org/10.2147/DDDT.S68393
40. Schneider E, Higgs S, Dourish CT. Lisdexamfetamine and binge-eating disorder: A systematic review and meta-analysis of the preclinical and clinical data with a focus on mechanism of drug action in treating the disorder.Eur Neuropsychopharmacol. 2021;53:49-78.https://doi.org/10.1016/j.euroneuro.2021.08.001
41. Fornaro M, Solmi M, Perna G, De Berardis D, Veronese N, Orsolini L et al. Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials. Neuropsychiatr Dis Treat. 2016;12:1827-36.https://doi.org/10.2147/NDT.S109637
42. Mathews M. Clinical Review - s-NDA 21977. Washington DC: FDA; 2011[acesso 22 out 2023].Disponível em:https://www.fda.gov/files/drugs/published/21977S-Lisdexamfetamine-Clinical-PREA.pdf
43. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – ICH. Guia introdutório do MedDRA versão 23.1. Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2020.
Downloads
Published
Issue
Section
Categories
License
Copyright (c) 2026 Health Surveillance under Debate: Society, Science & Technology
This work is licensed under a Creative Commons Attribution 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
