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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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“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 the citing paper
“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 citing paper
“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 citing paper
“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]
In the citing paper
“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].”
In the citing paper
“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
In the citing paper
“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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“with ADHD, methylphenidate increased sleep-onset latency significantly more than did atomoxetine, both considering actigraphic and polysomnographic data [123].”
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“In a randomized, double-blind trial, atomoxetine was associated with a smaller increase in sleep onset latency, a lower frequency of insomnia, a higher frequency of somnolence and smaller effects on subjective measures of sleep than methylphenidate taken three times daily (Sangal et al. 2006).”
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Self-citationStimulant medications and sleep for youth with ADHD: a meta-analysis
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“Most recently, the AW64 has been used in studies to assess sleep in children and adolescents with ADHD (Crabtree, Ivanenko, & Gozal, 2003; Sangal et al., 2006).”
MethodSleep Problems in the Child with Attention-Deficit Hyperactivity Disorder
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“However, our findings were very consistent with those by Sangal et al. (2006), who found that children taking TID MPH IR took on average 69 min to fall asleep compared to 30 min at baseline and 42 min on a nonstimulant medication for ADHD.”
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“While methylphenidate is effective during the daytime, the second-line medication atomoxetine increases noradrenergic function independently of the time of day (Sangal et al., 2006; Gamo et al., 2010), a fact which makes this substance interesting for the investigation of sleep in ADHD.”
BackgroundSleep disorders and attention-deficit/hyperactivity disorder
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“While fewer studies have examined the impact of nonstimulant ADHD medications on sleep parameters, a direct comparison of atomoxetine and methylphenidate in children found better sleep with atomoxetine treatment and worse sleep with methylphenidate (Sangal et al., 2006).”
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“Interestingly, studies reporting prolonged sleep latency are those where medication effects have been compared within-subject (Corkum et al., 2008; Sangal et al., 2006; Schwartz et al., 2004), our study inclusive.”
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“n D 9/ were excluded from these analyses, as atomoxetine has a potentially different impact on sleep than a psychostimulant (Sangal et al., 2006).”
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“In comparison with stimulants, atomoxetine causes less sleep problems which are common in ADHD and autism (Sangal et al., 2006). j. Finally, as atomoxetine is a nonstimulant medication and many parents worry about controlled medications, it is expected that atomoxetine be more accepted by the…”
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“Current orally administered stimulant treatment options have not addressed this challenge.”
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“In the same study, both methylphenidate and atomoxetine decreased nighttime awakenings as measured by PSG (Sangal et al., 2006).”
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“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 40
“[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 34
“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
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
Idrees, I., Bellato, A., Cortese, S., & Groom, M. J. (2022) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2022.104968 · Cited by 37
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
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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 31
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Li, Y., Gao, J., He, S., Zhang, Y., & Wang, Q. (2017) · Molecular Neurobiology · doi:10.1007/s12035-016-0179-6 · Cited by 26
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“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
Šelešovská, R., Navrátil, T., Hrdlička, V., et al. (2021) · Electrochimica Acta · doi:10.1016/j.electacta.2021.139642 · Cited by 25
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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 26
“…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 24
“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 23
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
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
Drug Class Review on Pharmacologic Treatments for ADHD
McDonagh, M. S., Peterson, K., & Thakurta, S. (2005) · Cited by 21
Metadata
- 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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