Effects of Atomoxetine and Methylphenidate on Sleep in Children With ADHD
Abstract
STUDY OBJECTIVES: This study compared the effects of atomoxetine and methylphenidate on the sleep of children with attention-deficit/hyperactivity disorder (ADHD). This study also compared the efficacy of these medications for treating ADHD in these children. DESIGN: Randomized, double-blind, crossover trial. SETTING: Two sleep disorders centers in the United States; 1 in a private-practice setting and 1 in a hospital setting. PATIENTS: 85 children diagnosed with ADHD. INTERVENTIONS: Twice-daily atomoxetine and thrice-daily methylphenidate, each for approximately 7 weeks. MEASUREMENTS AND RESULTS: Relative to baseline, the actigraphy data indicated that methylphenidate increased sleep-onset latency significantly more than did atomoxetine (39.2 vs 12.1 minutes, p < .001). These results were consistent with the polysomnography data. Child diaries indicated that it was easier to get up in the morning, it took less time to fall asleep, and the children slept better with atomoxetine, compared with methylphenidate. Parents reported that it was less difficult getting their children up and getting them ready in the morning and that the children were less irritable, had less difficulty getting ready for bed, and had less difficulty falling asleep with atomoxetine, compared with methylphenidate. There were no significant differences between medications using the main measures of efficacy for ADHD treatment. Atomoxetine was superior on some secondary ADHD treatment-efficacy measures, based on parent reports. The only significant differences in treatment-emergent adverse events were greater incidence of decreased appetite and greater incidence of insomnia with methylphenidate. CONCLUSIONS: Patients receiving twice-daily atomoxetine had shorter sleep-onset latencies, relative to thrice-daily methylphenidate, based on objective actigraphy and polysomnography data. Although both medications decreased nighttime awakenings, the decrease was greater for methylphenidate.
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A review of scientific studies comparing medicated and unmedicated children describes inconsistent outcomes, both for polysomnographic measures and for parental reports.
“However, a review of scientific studies comparing medicated and unmedicated children describes inconsistent outcomes, both for polysomnographic measures and for parental reports [123].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [123]
In a randomized, double-blind, cross-over study comparing methylphenidate (thrice daily) and atomoxetine (twice daily) in children with ADHD, methylphenidate increased sleep-onset latency significantly more than atomoxetine, based on actigraphic and polysomnographic data.
“In a randomized, double-blind, cross-over study comparing the effect of methylphenidate (given thrice daily) and atomoxetine (given twice daily) on the sleep of children with ADHD, methylphenidate increased sleep-onset latency significantly more than did atomoxetine, both considering actigraphic and polysomnographic data [123].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [123]
In the same study, both medications decreased night-time awakenings, but the decrease was greater for methylphenidate.
“Both medications decreased night-time awakenings, but the decrease was greater for methylphenidate.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [123]
In the same study, both children's diaries and parents' reports indicated better quality of sleep (getting ready in the morning, getting ready for bed, falling asleep) with atomoxetine compared with methylphenidate.
“Moreover, both childrens’ diaries and parents’ reports indicated a better quality of sleep (in terms of “getting ready in the morning”, “getting ready for bed”, “falling asleep”) with atomoxetine, compared with methylphenidate.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [123]
When data on standard deviations were missing, study authors were contacted or data were calculated using standard error of subgroups or confidence intervals.
“When data on standard deviations were missing, study authors were contacted to provide missing data [18] or it was calculated using the standard error of subgroups or confidence intervals [19-21].”
Nine randomized trials comparing methylphenidate and atomoxetine in ADHD children and adolescents were included, with a total of 2762 participants.
“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
Higher doses of atomoxetine administered twice daily may be more effective.
“The outcome in three of these trials favoured atomoxetine suggesting that higher doses of atomoxetine administered twice daily may be more effective.”
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BackgroundInfluentialAttention-deficit/Hyperactivity Disorder and Sleep Disorders in Children
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Robison, L. S., Michaelos, M., Gandhi, J., Fricke, D., Miao, E., Lam, C.-Y., Mauceri, A., Vitale, M., Lee, J., Paeng, S., et al. (2017) · Frontiers in Behavioral Neuroscience · doi:10.3389/fnbeh.2017.00053 · Cited by 38 · see citing works
Mattingly, G. W., Wilson, J. A., Ugarte, L., & Glaser, P. E. A. (2020) · CNS Spectrums · doi:10.1017/s1092852919001822 · Cited by 40 · see citing works
Effect of Lisdexamfetamine Dimesylate on Sleep in Children With ADHD
Giblin, J. M., & Strobel, A. L. (2011) · Journal of Attention Disorders · doi:10.1177/1087054710371195 · Cited by 38 · see citing works
“In the same study, both methylphenidate and atomoxetine decreased nighttime awakenings as measured by PSG (Sangal et al., 2006).”
BackgroundAdler, L. A., Goodman, D., Weisler, R. H., Hamdani, M., & Roth, T. G. (2009) · Behavioral and Brain Functions · doi:10.1186/1744-9081-5-34 · Cited by 36 · see citing works
Prasad, S., & Steer, C. (2008) · Pediatric Drugs · doi:10.2165/00148581-200810010-00005 · Cited by 35 · see citing works
Sangal, R. B., Sangal, J. M., & Thorp, K. (2007) · Sleep Medicine · doi:10.1016/j.sleep.2007.07.013 · Cited by 34 · see citing works
Self-citationBushe, C., & Savill, N. C. (2013) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-7-19 · Cited by 34 · see citing works
“The FDA has defined an approach that classifies adverse events relating to suicidality in set categories [16-18]: Table 1 Acute, paediatric, active comparator-controlled studi Study acronym Study design Start/ Stop dates Study duration (weeks) Age range (years) Numbers Inc HFBD [19] DB,MC, PC,R Nov 1998/ Feb 9 7-12 65…”
MethodInfluentialChin, W., Huang, Y., Chou, Y.-H., Wang, C.-H., Chen, K.-T., Hsu, J. F., & Hsu, S. (2018) · Biomedical Journal · doi:10.1016/j.bj.2018.10.004 · Cited by 35 · see citing works
“[22] Sangal RB, Owens J, Allen AJ, Sutton V, Schuh K, Kelsey D.”
BackgroundShang, C., Pan, Y.-L., Lin, H., Huang, L.-W., & Gau, S. S. (2015) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2015.0035 · Cited by 33 · see citing works
“Our findings provide further comparative information for the similar efficacy of OROS-methylphenidate and atomoxetine in reducing ADHD symptoms in children and adolescents (Kratochvil et al. 2002; Sangal et al. 2006).”
InfluentialKanemura, H., Sano, F., Tando, T., Hosaka, H., Sugita, K., & Aihara, M. (2013) · Epilepsy & Behavior · doi:10.1016/j.yebeh.2013.03.014 · Cited by 34 · see citing works
Spotlight on Atomoxetine in Attention-Deficit Hyperactivity Disorder in Children and Adolescents†
Garnock-Jones, K. P., & Keating, G. M. (2010) · CNS Drugs · doi:10.2165/11203670-000000000-00000 · Cited by 32 · see citing works
Idrees, I., Bellato, A., Cortese, S., & Groom, M. J. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104968 · Cited by 34 · see citing works
Effect of Methylphenidate on Sleep Parameters in Children with ADHD
Lee, S. H., Seo, W. S., Sung, H. M., Choi, T. Y., Kim, S. Y., Choi, S.-J., Koo, B. H., & Lee, J. H. (2012) · Psychiatry Investigation · doi:10.4306/pi.2012.9.4.384 · Cited by 30 · see citing works
Huang, Y., Jan, & Yang, C. (2011) · Psychology Research and Behavior Management · doi:10.2147/prbm.s14055 · Cited by 30 · see citing works
Morash-Conway, J., Gendron, M. A., & Corkum, P. V. (2016) · ADHD Attention Deficit and Hyperactivity Disorders · doi:10.1007/s12402-016-0204-7 · Cited by 29 · see citing works
Garg, J., Arun, P., & Chavan, B. S. (2014) · Indian Pediatrics · doi:10.1007/s13312-014-0445-5 · Cited by 27 · see citing works
Li, Y., Gao, J., He, S., Zhang, Y., & Wang, Q. (2017) · Molecular Neurobiology · doi:10.1007/s12035-016-0179-6 · Cited by 26 · see citing works
Bériault, M., Turgeon, L., Labrosse, M., Berthiaume, C., Verreault, M., Berthiaume, C., & Godbout, R. (2015) · Journal of Attention Disorders · doi:10.1177/1087054715605914 · Cited by 26 · see citing works
“Studies involving questionnaire measures suggest that children with ADHD on medication have more sleep problems than those not on medication, regardless of psychostimulant type and dosage (Cohen-Zion & Ancoli-Israel, 2004; Sangal et al., 2006).”
BackgroundFaraone, S. V., Schachar, R. J., Barkley, R. A., Nullmeier, R., & Sallee, F. R. (2017) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2016.0164 · Cited by 26 · see citing works
Šelešovská, R., Navrátil, T., Hrdlička, V., et al. (2021) · Electrochimica Acta · doi:10.1016/j.electacta.2021.139642 · Cited by 25 · see citing works
Dell’Agnello, G., Zuddas, A., Masi, G., Curatolo, P., Besana, D., & Rossi, A. (2009) · CNS Drugs · doi:10.2165/11314350-000000000-00000 · Cited by 25 · see citing works
Owens, J. A., Weiss, M. D., Nordbrock, E., Mattingly, G. W., Wigal, S. B., Greenhill, L. L., Chang, W.-W., Childress, A. C., Kupper, R. J., & Adjei, A. L. (2016) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2016.0083 · Cited by 25 · see citing works
“…treated with OROS methylphenidate actually showed a significant decrease in the number of awakenings (Kim et al. 2010), and subjective measures in another study indicated that nighttime awakenings were improved in children with ADHD treated with thrice-daily methylphenidate (Sangal et al. 2006).”
BackgroundSelf-citationVigliano, P., Galloni, G. B., Bagnasco, I., Delia, G., Moletto, A., Mana, M., & Cortese, S. (2016) · European Journal of Pediatrics · doi:10.1007/s00431-016-2695-9 · Cited by 22 · see citing works
“In addition, available PSG studies [12, 16, 27] assessed the sleep effects of psychostimulants, in particular,MPH, over a relatively short period of time (up to 7weeks); therefore, studies on longer-term effects of MPH are needed.”
BackgroundSleep as an outcome measure in ADHD randomized controlled trials: A scoping review
McWilliams, S., Zhou, T., Stöckler, S., Elbe, D., & Ipsiroglu, O. (2022) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2022.101613 · Cited by 22 · see citing works
Attention deficit hyperactivity disorder and risk of migraine: A nationwide longitudinal study
Hsu, T., Chen, M., Chu, C., Tsai, S., Bai, Y., Su, T., Chen, T., & Liang, C. (2022) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14306 · Cited by 22 · see citing works
Drugs That Disturb Sleep and Wakefulness
Schweitzer, P. K. (2011) · Elsevier eBooks · doi:10.1016/b978-1-4160-6645-3.00046-3 · Cited by 21 · see citing works
Drug Class Review on Pharmacologic Treatments for ADHD
McDonagh, M. S., Peterson, K., & Thakurta, S. (2005) · Cited by 21 · see citing works
- Authors
- Sangal, R. B., Owens, J., Allen, A. J., Sutton, V., Schuh, K., & Kelsey, D.
- Affiliations
- Rhode Island Hospital (US)
- Eli Lilly (United States) (US)
- Corresponding author
- Schuh, Kory
- Venue
- Sleep
- Publisher
- Oxford University Press (OUP)
- Published
- 2006-12
- Volume
- 29
- Issue
- 12
- Pages
- 1573-1585
- ISSN
- 0161-8105 (ISSN-L)
- 1550-9109
- OpenAlex
- W10589707
- Cited by
- 214
- References
- 0
- Citations by year
- 2026: 5 · 2025: 11 · 2024: 5 · 2023: 4 · 2022: 8 · 2021: 8 · 2020: 7 · 2019: 6 · 2018: 10 · 2017: 10 · 2016: 13 · 2015: 17 · 2014: 7 · 2013: 12 · 2012: 11
- FWCI
- 10.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- SLEEP (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Keywords
- atomoxetine, methylphenidate, attention deficit hyperactivity disorder, children, sleep latency, actigraphy, polysomnography, insomnia, nocturnal awakenings, adverse events, appetite loss
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dose-Response Relationship, Drug, Double-Blind Method, Electrophysiology, Female, Humans, Male, Methylphenidate, Propylamines, Sleep, REM, Cross-Over Studies, Adrenergic Uptake Inhibitors
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