Methylphenidate and Sleep Difficulties in Children and Adolescents With ADHD: Results From the 2-Year Naturalistic Pharmacovigilance ADDUCE Study.

Objective: Short-term RCTs have demonstrated that MPH-treatment significantly reduces ADHD-symptoms, but is also associated with adverse events, including sleep problems. However, data on long-term effects of MPH on sleep remain limited.
Methods: We performed a 2-year naturalistic prospective pharmacovigilance multicentre study. Participants were recruited into three groups: ADHD patients intending to start MPH-treatment (MPH-group), those not intending to use ADHD-medication (no-MPH-group), and a non-ADHD control-group. Sleep problems were assessed with the Children's-Sleep-Habits-Questionnaire (CSHQ).
Results: 1,410 participants were enrolled. Baseline mean CSHQ-total-sleep-scores could be considered clinically significant for the MPH-group and the no-MPH-group, but not for controls. The only group to show a significant increase in any aspect of sleep from baseline to 24-months was the control-group. Comparing the MPH- to the no-MPH-group no differences in total-sleep-score changes were found.
Conclusion: Our findings support that sleep-problems are common in ADHD, but don't suggest significant negative long-term effects of MPH on sleep.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AH has received compensation for serving as consultant or speaker for Shire–Takeda and Medice, unrelated to this work. KKCM reports grants from the CW Maplethorpe Fellowship, the UK National Institute for Health and Care Research (NIHR), the EU Horizon 2020 Framework, and the Hong Kong Research Grant Council, and personal fees from IQVIA Holdings, outside the submitted work. JB has been in the past 3 years a consultant, member of advisory board, or speaker for Takeda–Shire, Roche, Medice, Angelini, Janssen, and Servier. SC reports collaboration on projects from the EU Seventh Framework Programme and on clinical trials sponsored by Shire Pharmaceutical Company, Lundbeck, Otsuka, Janssen-Cilag, and Angelini. MD has received research funding from Takeda–Shire, outside the submitted work. RWD—For the past 3 years, he has no conflicts of interest to report. As a former company employee, he has been a stock holder of Eli Lilly & Co. BF has been a consultant or speaker for Abbvie, Actelion, Allergan, Almirall, Alnylam, Amgen, Astellas, Astrazeneca, Bayer, Biogen, Biopecs, Bioproject, Biotronik, BMS, Boehringer, Celgène, Daiichi-Sankyio, Ethypharm, Forestlab, Genevrier, Genzyme, Gilead, Grünenthal, GSK, Idorsia, IMS, Indivior, IQVIA, JNJ, Léo, Lilly, Lundbeck, Menarini, MSD, Novartis, Novonordisk, Otsuka, Pfizer, Pierre-Frabre, Recordati, Roche, SANOFI, Servier, Takeda, UCB, ViiV, and Wellmera. CH reports research funding from the NIHR including the Health Technology Assessment SATURN trial (grant ref: NIHR128472) comparing MPH with guanfacine for children and young people with ADHD and tics. CH was chair of the NICE Guideline (CG155) for psychosis and schizophrenia in children and young people; member of the NICE ADHD Guideline Update committee (NG87) and is a member of Eunethydis and the European ADHD Guideline Group. SM reports speaker’s fee, travel support, and research support from Shire, outside the submitted work. AN reports research funding from the EU, the German Ministry of Health, and the German Federal Joint Committee, outside the submitted work. PN has been a consultant or speaker for Medice, Servier, and Egis Pharmaceuticals, outside the submitted work. ER received speaker’s fee and travel support from Shire, outside the submitted work. ESB has received in the last 3 years speakers fees from Takeda and Medice and research support from QBTech. AZ served in an advisory or consultancy role for Angelini, EduPharma, Servier; received conference support or speaker’s fee from Angelini and Janssen; participated in clinical trials conducted by Angelini, Janssen, Lundbeck, Otsuka, Roche, Servier, and Shire; and received royalties from Giunti OS and Oxford University Press. ICKW reports research and educational funding from Amgen, Bristol Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, Takeda, the Hong Kong Research Grants Council, the Hong Kong Health and Medical Research Fund, the Hong Kong Innovation and Technology Commission, the NIHR, the EU, and the Australian National Health and Medical Research Council, and the expert testimony payment from the Hong Kong Court of Final Appeal; outside the submitted work. DC reports, in the past 3 years, a consultant, member of advisory board, or speaker role for Takeda–Shire, Medice, Novartis, and Servier. He has received royalties from Oxford University Press and Cambridge University Press; research support from the Australian National Health and Medical Research Council and the Royal Children’s Hospital Foundation; and funding for the current study from the European Commission. All other authors declare no competing interests. TB served in an advisory or consultancy role for Eyelevel, Infectopharm, Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg, Roche, and Takeda; received conference support or speaker’s fee from Jansen, Medice, and Takeda; and royalities from Hogrefe, Kohlhammer, CIP Medien, and Oxford University Press; outside the submitted work.