Methylphenidate Dosing: Twice Daily Versus Three Times Daily

Stein, Mark A.; Blondis, Thomas A.; Schnitzler, Eugene R.; O'Brien, Tara; Fishkin, Julie; Blackwell, Brad; Szumowski, Emily; Roizen, Nancy J.

doi:10.1542/peds.98.4.748

Cited by 152Attention Deficit Hyperactivity DisorderBehavioral and Psychological StudiesPharmaceutical studies and practices

Methylphenidate Dosing: Twice Daily Versus Three Times Daily

Stein, Mark A., Blondis, Thomas A., Schnitzler, Eugene R., O'Brien, Tara, Fishkin, Julie, Blackwell, Brad, Szumowski, Emily, Roizen, Nancy J.·1996·Pediatrics

DOI 10.1542/peds.98.4.748

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Abstract

Objective. To evaluate the short-term efficacy and side effects associated with two methylphenidate hydrochloride (MPH) dosing patterns. Methods. Twenty-five boys with attention deficit hyperactivity disorder (ADHD) participated in a 5-week, triple-blind, placebo-controlled, crossover evaluation of MPH administered twice (b.i.d.) versus thrice (t.i.d.) per day (mean dose 8.8 ± 5 mg, .30 ± .1 mg/kg/dose). Four dosing conditions (placebo, titration [gradual increase to target dose], b.i.d., and t.i.d.) were used. Dependent measures obtained on a weekly basis included: parent and teacher ratings of child behavior, parent-child conflicts, parent report of stimulant side effects, child self-report of mood symptoms, a sleep log, laboratory measures of attention, and actigraphic recording of sleep activity. Results. All dosing conditions resulted in significant effects on ADHD symptoms when compared with baseline. Relative to placebo, t.i.d. dosing was characterized by improvement on the greatest number of behavioral measures, and both b.i.d. and t.i.d. were generally more effective than titration. Direct comparisons of b.i.d. and t.i.d. dosing revealed that t.i.d. was associated with greater improvement on the Conners Parent Rating Scale Impulsivity/Hyperactivity factor, with a similar marginally significant effect for the ADD-H Teacher Rating Scale Hyperactivity factor. The analysis of clinically significant change favored a three-times-a-day dosing schedule over placebo on both parent and teacher ratings of impulsivity/hyperactivity and attention. Compared with placebo, appetite suppression was rated, on average, as more severe in the t.i.d. and titration conditions, but not in the b.i.d condition. However, the number of subjects who exhibited any or severe appetite suppression did not differ significantly between the b.i.d. and t.i.d. schedules. Although there was no difference in sleep duration for children on b.i.d. and t.i.d. schedules, total sleep time appeared to decrease slightly on t.i.d. relative to placebo according to both parent ratings and actigraphic assessment. There were no significant differences between b.i.d. and t.i.d. on any other side effects or sleep variables. Conclusions. For many children with ADHD, t.i.d. dosing may be optimal. There are few differences in acute side effects between b.i.d and t.i.d. MPH dosing. The dosing schedule should be selected according to the severity and time course of ADHD symptoms rather than in anticipation of dosing schedule-related side effects.

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Studies using a third dose of stimulants at the end of the day found a greater sleep-onset delay in children treated with stimulants compared to untreated subjects.
“Other studies, however, using a third dose at the end of the day did find a greater sleep-onset delay in children treated with stimulants compared to untreated subjects [7, 137].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [137]

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“Therefore, a total of 23 trials, involving 2959 subjects, were included in our meta-analysis (Gittelman-Klein et al. 1976; Conners and Taylor 1980; Werry et al. 1980; Rapport et al. 1985; Barkley et al. 1990; Ahmann et al. 1993; Buitelaar et al. 1996; Stein et al. 1996; Gillberg et al. 1997; Firestone et al. 1998; Pli…”
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“…10 mg Solanto et al. (2009) 25 (44) 8.8 (1.5)/7–12h 16 96 CPT Omissionshh 1.02 (0.20) Fixedb,e 3 d.d. 1 week/ condition IR, 20 mg Mean = 0.59 mg/kg Stein et al. (1996) 25 (100) 8.0 (1.8)/6–12 28 44 TOVA Omissionshh 0.29 (0.20) Fixede 2 d.d. 1 week/ condition IR, mean = 0.3 mg/kg Sunohara…”
Influential
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Background
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Untitled work
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ResultInfluential
Actigraphic Monitoring During Sleep of Children With ADHD on Methylphenidate and Placebo
SCHWARTZ, G., AMOR, L. B., GRIZENKO, N., LAGEIX, P., BARON, C., BOIVIN, D. B., & JOOBER, R. (2004) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000135802.94090.93 · Cited by 70 · see citing works
“The same group (Stein et al., 1996) exploring the effect of twice-daily and three times daily dosing had previously found no sleep differences on actigraphic recordings of sleep on the two dosing regimens.”
Background
Psychostimulants in supportive care
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A Framework for the Assessment and Treatment of Sleep Problems in Children with Attention-Deficit/Hyperactivity Disorder
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New methylphenidate formulations for the treatment of attention-deficit/hyperactivity disorder
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Background
Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials
Holmskov, M., Storebø, O. J., Moreira-Maia, C. R., Ramstad, E., Magnusson, F. L., Krogh, H. B., Groth, C., Gillies, D., Zwi, M., Skoog, M., et al. (2017) · PLOS ONE · doi:10.1371/journal.pone.0178187 · Cited by 58 · see citing works
The effect of OROS methylphenidate on the sleep of children with attention-deficit/hyperactivity disorder
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Bioavailability of melatonin in humans after day-time administration of D7 melatonin
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Population Pharmacokinetics of Methylphenidate in Children with Attention‐Deficit Hyperactivity Disorder
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“Furthermore, less insomnia and fewer negative emotional symptoms were reported for methylphenidate compared to d-amphetamine.26 Only one study could be located that compared bid and tid dosage schedules for methylphenidate—a triple-blind, placebo-controlled, counterbalanced, crossover study in 25 boys with ADHD.27 The…”
BackgroundInfluential
The impact of late-afternoon stimulant dosing for children with ADHD on parent and parent-child domains
Chronis, A. M., Pelham, W. E., Gnagy, E. M., Roberts, J. E., & Aronoff, H. R. (2003) · Journal of Clinical Child & Adolescent Psychology · doi:10.1207/s15374424jccp3201_11 · Cited by 52 · see citing works
“To date, few studies have evaluated the relative effectiveness of a late-afternoon dose of MPH compared to standard twice-daily dosing (BID; Kent, Blader, Koplewicz, Abikoff, & Foley, 1995; Stein et al., 1996).”
BackgroundMethodResult
Abuse-Deterrent and Tamper-Resistant Opioid Formulations
Schneider, J. P., Matthews, M. L., & Jamison, R. N. (2010) · CNS Drugs · doi:10.2165/11584260-000000000-00000 · Cited by 51 · see citing works
Double-blind Methylphenidate Trials
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“Double-blind, placebo-controlled protocols for the use of methylphenidate have been reported previously.(11-19) These studies, in which groups of children with ADD were randomized to 1 of 2 study treatment arms, were designed to compare the efficacy of placebo and of methylphenidate.”
Method
Zebrafish models for attention deficit hyperactivity disorder (ADHD)
Fontana, B. D., Franscescon, F., Rosemberg, D. B., Norton, W., Kalueff, A. V., & Parker, M. O. (2019) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2019.02.009 · Cited by 47 · see citing works
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“2001) or number of times per day administered (Stein et al. 1996), so we did not exclude studies on these bases, but we recorded information on the intervention in the table of included studies.”
Background
STIMULANT MEDICATION FOR THE CHILD WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
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Effectiveness and safety of methylphenidate in adult attention deficit hyperactivity disorder in patients with epilepsy: An open treatment trial
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Evolution of stimulants to treat ADHD: transdermal methylphenidate
Patrick, K. S., Straughn, A. B., Perkins, J. S., & Ángel-González, M. (2008) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.992 · Cited by 42 · see citing works
“This three-times-daily MPH schedule carries with it a higher incidence of appetite suppression and insomnia (Stein et al., 1996).”
Sleep-Associated Adverse Events During Methylphenidate Treatment of Attention-Deficit/Hyperactivity Disorder
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Effect of Lisdexamfetamine Dimesylate on Sleep in Children With ADHD
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“…methylphenidate on sleep in children with ADHD, sleep-onset latency was significantly increased for children on thricedaily methylphenidate relative to baseline and also when compared with twice-daily atomoxetine based on both objective and subjective measures of sleep (Stein et al., 1996).”
BackgroundResultInfluential
Cost-Effectiveness of Dexamphetamine and Methylphenidate for the Treatment of Childhood Attention Deficit Hyperactivity Disorder
Donnelly, M., Haby, M. M., Donnelly, M., Haby, M. M., Carter, R., Andrews, G., & Vos, T. (2004) · Australian & New Zealand Journal of Psychiatry · doi:10.1080/j.1440-1614.2004.01422.x · Cited by 38 · see citing works
Subjective and objective assessments of sleep problems in children with attention deficit/hyperactivity disorder and the effects of methylphenidate treatment
Chin, 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
“Besides, it is important to note that some studies have previously demonstrated no change in sleep quantity [38] and even increased sleep efficiency after MPH use [39].”
Background
Methylphenidate Side Effect Profile Is Influenced by Genetic Variation in the Attention-Deficit/Hyperactivity Disorder-Associated CES1 Gene
Johnson, K. A., Barry, E., Lambert, D., Fitzgerald, M., McNicholas, F., Kirley, A., Gill, M., Bellgrove, M. A., & Hawi, Z. (2013) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2013.0032 · Cited by 34 · see citing works
“The most common side effects of MPH are insomnia, decreased appetite, stomachaches, and headaches (Gittelman-Klein et al. 1976; Barkley et al. 1990; Stein et al. 1996; Efron et al. 1997; Schachter et al. 2001).”
Single-Dose Pharmacokinetics of Methylphenidate Extended-Release Multiple Layer Beads Administered as Intact Capsule or Sprinkles Versus Methylphenidate Immediate-Release Tablets (Ritalin ® ) in Healthy Adult Volunteers
Adjei, A. L., Teuscher, N. S., Kupper, R. J., Chang, W.-W., Greenhill, L. L., Newcorn, J. H., Connor, D. F., & Wigal, S. B. (2014) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2013.0135 · Cited by 33 · see citing works
“potential for reducing related adverse events (AEs) (Stein et al. 1996; Greenhill et al. 1999; Markowitz et al. 2003a; Steele et al. 2006; Wigal et al. 2006; Rader et al. 2009).”
New Research on the Complex Interaction of Sleep and ADHD
Weiss, M. D., Craig, S. G., Davies, G., Schibuk, L., & Stein, M. A. (2015) · Current Sleep Medicine Reports · doi:10.1007/s40675-015-0018-8 · Cited by 30 · see citing works
“Early studies showed actigraphic changes in children with ADHD, demonstrating sleep onset insomnia (SOI), decreased sleep duration, sleep variability and sleep efficiency [20, 27, 28].”
BackgroundSelf-citation
The role of sleep quality and quantity in moderating the effectiveness of medication in the treatment of children with ADHD
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
“Of those studies that have, it has been reported that medication significantly increased sleep onset latency (Corkum, Panton, Ironside, MacPherson, & Williams, 2008; Tirosh et al., 1993), and reduced total sleep time compared to placebo (Stein et al., 1996; Tirosh, Sadeh, Munvez, & Lavie, 1993).”
Background
GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children
DeVeaugh-Geiss, J., Conners, C. K., Sarkis, E. H., Winner, P. K., Ginsberg, L. D., Hemphill, J. M., Laurenza, A., BARROWS, C. F., WEBSTER, C. J., STOTKA, C. J., et al. (2002) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/00004583-200208000-00009 · Cited by 28 · see citing works
“Although the most commonly used stimulants such as methylphenidate and the amphetamines have efficacy rates as high as 70% in controlled studies, they do not work for all patients with ADHD (Stein et al., 1996).”
Background
Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Cândido, R. C. F., de Padua, C. A. M., Golder, S., & Junqueira, D. R. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013011.pub2 · Cited by 33 · see citing works
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Can we predict short-term side effects of methylphenidate immediate-release?
Karabekiroğlu, K., Yazgan, Y., & Dedeoğlu, C. (2008) · International Journal of Psychiatry in Clinical Practice · doi:10.1080/13651500701435954 · Cited by 21 · see citing works
“For decades, stimulant medication, particularly methylphenidate (MPH), is the most frequently recommended medical treatment for ADHD [3].”
Background
Drug Class Review on Pharmacologic Treatments for ADHD
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MANAGEMENT OF STIMULANT MEDICATIONS IN CHILDREN WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
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Open-Label Amantadine in Children with Attention-Deficit/Hyperactivity Disorder
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“…disorder (ADHD) is well established, but it is estimated that be-tween 10% and 30% of patients treated with these drugs either do not improve adequately, or are unable to tolerate their side effects (Elia et al. 1991; Spencer et al. 1996; Stein et al. 1996; Pelham et al. 1999).”
Safety of stimulant treatment in attention deficit hyperactivity disorder: part I
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Background
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“Indeed, using actigraphy it was already demonstrated that triple dosing vs double dosing with MPH decreases total sleep time in children with ADHD, presumably due to a later dosing in time (30); clearly this is a factor that needs to be taken into account both in clinical studies and clinical practice.”
Method
Steady-State Bioavailability of Extended-Release Methylphenidate (MPH-MLR) Capsule vs. Immediate-Release Methylphenidate Tablets in Healthy Adult Volunteers
Adjei, A. L., Kupper, R. J., Teuscher, N. S., Wigal, S. B., Sallee, F. R., Childress, A. C., Kollins, S. H., & Greenhill, L. L. (2014) · Clinical Drug Investigation · doi:10.1007/s40261-014-0234-x · Cited by 17 · see citing works
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Background
Attention Deficit Hyperactivity Disorder Medications and Sleep
Stein, M. A., Zulauf-McCurdy, C. A., & DelRosso, L. M. (2022) · Child and Adolescent Psychiatric Clinics of North America · doi:10.1016/j.chc.2022.03.006 · Cited by 17 · see citing works
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Methylphenidate
National Cancer Institute (2020) · Definitions · doi:10.32388/gfsn0o

Authors: Stein, M. A., Blondis, T. A., Schnitzler, E. R., O'Brien, T., Fishkin, J., Blackwell, B., Szumowski, E., & Roizen, N. J.
Affiliations: University of Chicago (US)
ORCID: Stein, Mark A.
Roizen, Nancy J.
Venue: Pediatrics
Publisher: American Academy of Pediatrics (AAP)
Published: 1996-10-01
Volume: 98
Issue: 4
Pages: 748-756
ISSN: 0031-4005 (ISSN-L)
1098-4275
DOI: 10.1542/peds.98.4.748
OpenAlex: W1521375496
Cited by: 151
References: 0
Citations by year: 2025: 1 · 2024: 1 · 2023: 2 · 2022: 3 · 2021: 3 · 2020: 4 · 2019: 4 · 2018: 3 · 2017: 3 · 2016: 3 · 2015: 4 · 2014: 2 · 2013: 5 · 2012: 4
FWCI: 6.18
Type: journal article
Language: en
Open access: closed
Locations: PEDIATRICS (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: methylphenidate, dosing frequency, twice-daily dosing, three-times-daily dosing, attention deficit hyperactivity disorder, children, stimulant side effects, appetite suppression, sleep duration, sleep quality, impulsivity, hyperactivity, attention, dose titration, parent and teacher ratings, actigraphy, mood symptoms, parent-child conflict, ADHD medication
MeSH terms: Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Capsules, Child, Child Behavior, Cognition, Follow-Up Studies, Humans, Male, Methylphenidate, Sleep, Time Factors

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Methylphenidate Dosing: Twice Daily Versus Three Times Daily

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