EDUCATION

JPPT | Review

Diagnosis and Treatment of ADHD in the Pediatric

Population
Lea S. Eiland, PharmD and Brooke L. Gildon, PharmD

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders

in childhood with approximately 6 million children (age 3 to 17 years) ever diagnosed based on data from
2016–2019. ADHD is characterized by a constant pattern of inattention and/or hyperactivity-impulsivity
symptoms that interferes with development or functioning. Specific criteria from the Diagnostic and Statisti-
cal Manual of Mental Disorders, 5th edition Text Revision assist with the diagnosis with multiple guidelines
available providing non-pharmacologic and pharmacologic recommendations for the treatment of ADHD in
the pediatric population. While all guidelines similarly recommend behavioral and/or stimulant therapy as
first-line therapy based on age, not all stimulant products are equal. Their differing pharmacokinetic profiles
and formulations are essential to understand in order to optimize efficacy and safety for patients. Addition-
ally, new stimulant products and non-stimulant medications continue to be approved for use of ADHD in the
pediatric population and it is important to know their differences in formulation, efficacy, and safety to other
products currently available. Lastly, due to drug shortages, it is important to understand product similarities
and differences to select alternative therapy for patients.
ABBREVIATIONS AAP, American Academy of Pediatrics; ADHD, attention-deficit/hyperactivity disorder;
BP, blood pressure; DSM-5-TR, Diagnostic and Statistical Manual, Fifth Edition, Text Revision; ER, extended
release; FDA, Food and Drug Administration; HR, heart rate; NICE, National Institute for Health and Care
Excellence; NSCH, National Survey of Children’s Health; PTBM, parent training in behavior management;
XR, extended release
KEYWORDS amphetamine; attention deficit disorder with hyperactivity; attention deficit hyperactivity
­disorder; methylphenidate; off-label use; pediatrics; serotonin and norepinephrine reuptake inhibitors
J Pediatr Pharmacol Ther 2024;29(2):107–118

DOI: 10.5863/1551-6776-29.2.107

Introduction had estimates significantly lower than the rest of the

Attention-deficit/hyperactivity disorder (ADHD) is one country while Alabama, Arkansas, Delaware, Georgia,
of the most common neurodevelopmental disorders in Indiana, Kentucky, Louisiana, Maine, Mississippi, New
childhood characterized by a constant pattern of inat- Hampshire, North Carolina, Ohio, South Carolina, Ten-
tention and/or hyperactivity-impulsivity symptoms that nessee, and West Virginia had estimates higher com-
interferes with development or functioning.1,2 pared with the rest of the country.5 The prevalence of
Prevalence. Attention-deficit/hyperactivity disor- ADHD in males (13.3%) is more than twice that in fe-
der begins in childhood.1 Worldwide prevalence in males (6.1%).3 The highest prevalence of ADHD is seen
children is approximately 7.2% based on population in Black, non-Hispanic (12%) and White, non-­Hispanic
surveys.1 Parent-reported data from the 2016–2019 (10.9%) populations while the lowest prevalence is in
US National Survey of Children’s Health (NSCH) es- the Asian, non-Hispanic (2.6%) and Hispanic (7.5%)
timates that 9.8% (approximately 6 million) of children populations. ADHD is more common in children in
age 3 to 17 years had ever received a diagnosis of rural areas compared with urban or suburban areas.
ADHD and 8.7% currently had the disorder.3,4 By age, Patients categorized as being in the lowest federal
adolescents who ever had ADHD are the highest at poverty level and having public insurance also have a
13% (3.3 million). Children aged 6 to 11 years are 10% higher prevalence of ADHD.
(2.4 million) and 2% (265,000) of children 3 to 5 years Etiology. The exact cause and risk factors for ADHD
follow. State prevalence of ADHD varies. The NSCH are unknown; however, the heritability of ADHD is
found a range of 6.1% to 16.3% (median 10.5%) for chil- increased in first-degree relatives of a patient with
dren who ever had ADHD and 5.3% to 14.4% for those ADHD with an estimate of 74%.1,2,6 The involvement
with a current diagnosis.3,5 California, Hawaii, Nebras- of dopaminergic and adrenergic neurotransmitters in
ka, Nevada, New Jersey, New York, and South Dakota ADHD continues to be studied as medication ­affecting

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ADHD Diagnosis and Treatment in the Pediatric Population Eiland, L et al

these neurotransmitters are the most effective first- assist clinicians with diagnosis and follow-up assess-
line pharmacotherapy.6 Environmental factors may ments after therapy is initiated. The use of parent-
also play a role in ADHD. Prenatal exposure to smok- reported or teacher-reported behavior-rating scales
ing has been associated with ADHD and patients who began in the late 1960s.6 Today, there are clinician-,
have a very low birth weight and degree of prematu- parent-, self-, and teacher-reported rating scales. The
rity have an increased risk for ADHD.1 ADHD Rating Scales, Conners Rating Scales, and Na-
Diagnosis. There are 3 subtypes of ADHD. Pa- tional Institute for Children’s Health Quality Vanderbilt
tients are categorized as predominately inattentive, Assessment Scales are commonly used in practice
predominately hyperactive/impulsive, or combined for preschool-age children to adolescents. Clinicians
(involving symptoms from both inattention and hy- should ensure they are using the appropriate rating
peractivity/impulsivity domains). For ADHD diagnosis, scale for the patient’s age, the person completing the
per the Diagnostic and Statistical Manual of Mental scale, and purpose. The scales assist with ADHD di-
Disorders, Fifth Edition, Text Revision (DSM-5-TR), pa- agnosis by converting subjective symptom informa-
tients must have 6 or more of the 9 symptoms in the tion into objective data and then allow an objective
inattention domain, hyperactivity/impulsivity domain, manner for follow-up. The scale can also identify the
or both domains for at least 6 months (Table 1).1 Hy- subtype of ADHD. Providers can compare the objec-
peractivity is the primary symptom in preschool age tive outcomes to prior ratings to evaluate for symptom
children with inattention being prominent during ages
5 to 9 years. More subtle signs of hyperactivity are
Table 1. DSM-5-TR Attention-Deficit/Hyperactivity
noted in the adolescent population such as fidgeting Disorder Symptoms by Domain1*
or feelings of restlessness, impatience, or jitteriness.
Despite age, symptoms must negatively affect aca- Inattention Hyperactivity and
demic/occupational and social activities and not be Impulsivity
consistent with the development level of the patient. Often fails to provide Often fidgets with or taps
Adolescents only require 5 symptoms in a domain close attention to detail hands/feet or fidgets in
for diagnosis. Symptoms should be present before or makes careless errors seat
the age of 12 years and occur in 2 or more settings in schoolwork, at work, or
(home, school, work, socially, etc) for diagnosis. Lastly, during other activities
for diagnosis, symptoms must clearly interfere with or Often has difficulty focusing Often leaves seat in
decrease the quality of academic/occupational or so- on tasks or activities situations when is it
cial activities and not be better supported by another expected to remain
psychotic or mental disorder diagnoses. Mild ADHD is seated
classified in the DSM-5-TR as the patient having “few,
Often does not seem to be Often inappropriately
if any, symptoms in excess of those required to make listening when spoken to runs around or climbs in
the diagnosis are present, and symptoms result in no directly situations
more than minor impairments in social or occupational
functioning.”1 Severe ADHD is classified “many symp- Often fails to follow through Often cannot play
on instructions and fails or engage in leisure
toms in excess of those required to make the diagno-
to complete schoolwork, activities quietly
sis, or several symptoms that are particularly severe, chores, or duties
are present, or the symptoms result in marked impair-
ment in social or occupational functioning.” Moderate Often has difficulty Often is “on the go”
severity is described as symptoms or impairment be- organizing and managing
tween the mild and severe classifications. tasks and activities
Patients with ADHD frequently have comorbid dis- Often avoids, dislikes, or Talks excessively often
orders.1 Half of children with the combined subtype is hesitant to participate in
and approximately one-fourth of children with the tasks requiring sustained
predominantly inattentive subtype will also present mental effort
with oppositional defiant disorder. About one-fourth Often loses items necessary Shouts out an answer
of children and adolescents with combined subtype for tasks or activities before a question has
will have conduct disorder. Autism spectrum disorder, been completed often
obsessive-compulsive disorder, and tic disorders can
Easily distracted by Inability waiting his or her
occur concomitantly with ADHD. It is recommended by
extraneous stimuli often turn often
the American Academy of Pediatrics (AAP) to screen
for comorbid conditions in a child or adolescent with Forgetful in daily activities Interrupts or intrudes on
ADHD.7 often others often
Rating Scales. Several ADHD clinical questionnaires * Six symptoms (5 for adolescents) must be met in each individual
and rating scales based on the DSM are ­available to domain to be classified as combined subtype.

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Eiland, L et al ADHD Diagnosis and Treatment in the Pediatric Population

improvement or worsening over time. Additionally, the The European National Institute for Health and Care
provider can objectively evaluate symptoms in differ- Excellence (NICE) ADHD guidelines were released in
ent settings if the parent and teacher complete forms. 2008 with the most recent update published March
Guidelines. Several guidelines are available to 2018.12 Two additional amendments were released
assist clinicians with the diagnosis and treatment of in 2018 and 2019. Group-parent training programs,
ADHD in the pediatric population.7–9 The AAP first individual-parent training programs, and cognitive
begin publishing pediatric guidelines for ADHD in behavioral therapy are recommended for patients
2000.7 The most current guideline was released in and carers depending on the age of the patient. For
2019 and provides incremental updates, a process patients 5 years of age and older, methylphenidate,
of care algorithm, and a companion article on sys- lisdexamfetamine, and atomoxetine or guanfacine
temic barriers to the care of pediatric patients (4 to are recommended in this order. The Canadian ADHD
18 years of age) with ADHD.7 The AAP guidelines Practice Guidelines were first released in 2006 with the
recommend ADHD diagnosis is based on the DSM-5 current fourth edition released in 2018.13 A multimodal
criteria. Their recommended first-line treatment for treatment plan including psychosocial therapy and
ADHD in preschool-aged children (age 4 years to the medications is recommended. Long-acting stimulants
sixth birthday) includes evidence-based parent train- are recommended as first-line agents with atomox-
ing in behavior management (PTBM) and/or behav- etine, guanfacine extended release (XR) and short or
ioral classroom interventions.7 Methylphenidate can intermediate-acting stimulants as second-line. Third-
be initiated if behavioral interventions fail to signifi- line agents recommended are bupropion, clonidine,
cantly improve symptoms and functioning continues imipramine, and modafinil. Both NICE and Canadian
to be impaired during ages 4 to 5 years. For children guidelines recommend the DSM-5-TR criteria for ADHD
ages 6 years to the 12th birthday, first-line treatment diagnosis and also include recommendations for the
for ADHD includes a Food and Drug Administration treatment of adults.12,13
(FDA)-approved medication and/or PTBM and/or be-
havioral classroom interventions, with both behavioral Non-Pharmacological Therapies
therapies being preferred as an adjunct to medica- Behavioral therapy is strongly recommended for par-
tion therapy. First-line ADHD therapy for adolescents ents of and patients with ADHD. Examples of evidence-
(age 12 years to the 18th birthday) is treatment with based behavioral and educational interventions include
a FDA-approved medication with the patient’s assent. PTBM, behavioral classroom management, behavioral
Evidenced-based training interventions and/or behav- peer intervention, and individualized instructional sup-
ioral interventions are encouraged. Stimulants are the port (e.g., instructional and class placement, Individual-
recommended first-line medication therapy due to ized Education Program, or rehabilitation plan).7,9 Many
their efficacy and strength of evidence. PTBM pre-school programs are group programs.7
The American Academy of Child and Adolescent Psy- Behavioral classroom interventions are also recom-
chiatry first published an ADHD practice parameter in mended if the child attends pre-school. Older children
1997 and issued their most recent parameter in 2007.8 can additionally complete organizational skills training.9
Treatment recommendations are similar to the AAP Behavioral parent and classroom training have positive
guidelines. The Society for Developmental and Behav- outcomes in preadolescent children.7 For adolescents
ioral Pediatrics published “Clinical Practice Guideline with ADHD, PTBM may involve parents and adolescents
for the Assessment and Treatment of Children and in sessions and training focusing on school function-
Adolescents with Complex Attention-Deficit/Hyperac- ing skills is effective. For the adolescent, training that
tivity Disorder” in 2020.9 This was the first guideline is continued over time, has frequent and constructive
from the Society of which they described the intention feedback, and is targeted at specific behaviors has the
of the work to complement the AAP guidelines. “Com- greatest benefit.7 Additionally, in children and adoles-
plex ADHD” is defined based on age (presentation at cents, psychosocial interventions such as behavioral
<4 years or >12 years), presence or suspicion of coexist- therapy and training interventions have been effective.
ing conditions, moderate to severe impairment in daily Training in social skills has not demonstrated benefit
living function, uncertainty of diagnosis, or inadequate for children with ADHD.7 Outcomes from behavioral
response to treatment. This guideline provides psy- therapies tend to continue even after therapy ends.
chosocial (behavioral, educational, and psychological Digital therapeutics have emerged as a therapy for
interventions), pharmacological treatment recommen- ADHD. One systematic review and meta-analysis of
dations, and information regarding therapy for ADHD video game-based therapeutic interventions found that
and comorbid conditions. it was effective in decreasing ADHD symptoms and im-
The AAP also has a 2014 clinical report regarding proving cognitive areas.14 Typically these games focus
ADHD and substance abuse and a world consensus on cognitive training such as improving attention, mem-
statement was published in 2023 on treating patients ory, reaction time, cognitive flexibility, or motor ability.
with ADHD and substance use disorder.10,11 Patients were found to have a high engagement with

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ADHD Diagnosis and Treatment in the Pediatric Population Eiland, L et al

the games as there were low rates of dropouts from the care.7 Studies have found amphetamines to have better
studies. Another systematic review and meta-analysis response rates at the group level when compared with
found that digital therapeutics improved inattention methylphenidate and the non-stimulants.18 Yet, at the
and hyperactivity/impulsivity symptoms compared with patient level, participants had equally good response
control but medication improved inattention and sig- to both amphetamine and methylphenidate. Another
nificantly improved hyperactivity/impulsivity better than systematic review found amphetamine, as compared
game-based digital therapeutics.15 EndeavorRx was the with methylphenidate, to be slightly more efficacious
first game-based digital therapeutic device approved in reducing core ADHD symptoms in children and ado-
by the FDA to improve attention function in children 8 lescents, yet methylphenidate was better tolerated.17
to 12 years of age with ADHD (primarily inattentive or Based on both safety and efficacy data in children,
combined-type).16 This approval in 2020 was the first and what is commonly seen in practice, it is prudent to
type of game-based FDA approval for any disease or start with methylphenidate and reserve amphetamines
condition. It is available only via prescription and should for future needs.
be part of a comprehensive patient treatment plan. When selecting a long-acting stimulant product, the
clinician should match the pharmacokinetic profile of
Pharmacologic Treatments the medication dosage form to the needs of the pa-
US Food and Drug Administration-approved medica- tient. Duration of efficacy should match the duration
tions for the treatment of ADHD include stimulant and needed for symptom control. However, based on the
non-stimulant options.1,7 The stimulants are described pharmacokinetic design of the medication formulation,
in 2 classes, methylphenidate and amphetamine. the drug release profile should be matched to the
Atomoxetine, viloxazine, guanfacine, and clonidine patient’s needs. For example, a patient who has more
represent non-stimulant choices commonly used in severe symptoms in the morning may need a product
the management of ADHD. Stimulants have an ef- that is 50% immediate release compared with one that
fect size of 1 for treating ADHD, while non-stimulants is 22% immediate release. It is important to remember
(atomoxetine and extended-released guanfacine and that increasing a dose to increase efficacy can increase
clonidine) have an effect size of 0.7.7 Bupropion, may adverse effects as well; thus, changing products to a
be used off-label in patients non-responsive or unable different pharmacokinetic profile may provide improved
to take an FDA-approved agent, or with a coexisting efficacy without additional adverse effects. Additionally,
mental health diagnosis.17 The initial medication therapy a patient who has more late afternoon/early evening
choice depends on several factors. Some general con- symptoms may do better with a product that 70% to 80%
siderations include duration of desired coverage, ability of the dose is released in the second pharmacokinetic
of the patient to swallow solid dosage forms, time(s) release to provide longer lasting efficacy of symptoms
of day when target symptoms occur, pharmacokinetic compared with a dose that provided 50% for the second
properties of the dosage formulation, desire to avoid release. Tables 2 and 3 provide pharmacokinetic and
administration at school, coexisting disorder or condi- dosage formulation information for the stimulants.20–39
tion, potential adverse effects, history of substance Lastly, most stimulant products are not interchangeable
abuse, preference of patient/caregiver, and medication on a milligram-for-milligram basis and may require a ta-
expense and availability. per off/on when a change of agents is required. Product
Stimulants. The stimulant class is recommended medication labeling should always be referenced for
first-line in the management of ADHD due to the ex- guidance regarding equivalence and/or a process for
tensive evidence of efficacy and a known safety pro- conversion, if available.
file.1,7,18 Stimulants work by blocking the presynaptic Across the stimulant class, proper baseline and
reuptake of norepinephrine and dopamine, with am- periodic monitoring of safety/adverse events are
phetamine also increasing the presynaptic release paramount.7,18,40 Table 4 highlights variables to moni-
of dopamine and serotonin. Some areas of the brain tor, frequency of monitoring, and important points to
known to show neurotransmitter impact include stria- consider.7,12,18,40 Also, critical to drug selection is the
tal dopamine transporters and norepinephrine trans- medication adverse effect profile. Table 5 shows com-
porters in the frontal lobes.19 Both methylphenidate mon stimulant adverse events and suggested manage-
and amphetamine improve the core symptoms of ment strategies.7,18 In the end, stimulant selection within
ADHD, hyperactivity/impulsivity, and inattention, and ADHD management is patient-specific with a balance
have also shown improvements in academic func- of efficacy, safety, and management of medication
tioning and a decreased risk of unintentional injuries, adverse events.
motor vehicle accidents (among male patients), and A final consideration with the stimulant class is
criminal acts.7,18 related to serious risks with misuse, abuse, addiction,
The AAP clinical practice guideline does not specify overdose, and sharing of these medications.41 The FDA
which stimulant class is more effective nor name a published a drug safety communication in May of 2023
preferred starting product as part of the standards of updating warnings to improve the safe use of stimulants

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 Eiland, L et al ADHD Diagnosis and Treatment in the Pediatric Population

Table 2. Methylphenidate-based Stimulants20–29

Medication Brand Name Frequency of Immediate Sustained Duration Formulation(s) Available
(US) Dosing Release/First Release/ of Action Strengths
Dose Release Second Dose (hr)
Release

Immediate release
Methylphenidate Ritalin* BID-TID 100% — 3–5 Tablet 5, 10, 20 mg
Methylin* BID-TID 100% — 3–5 Chewable tablet 2.5, 5, 10 mg;
(Grape flavor); 5, 10 mg/5 mL
solution (Grape
flavor)
Dexmethylphenidate Focalin* BID 100% — 3–5 Tablet 2.5, 5, 10 mg

Extended release
Methylphenidate Ritalin LA* Once daily 50% 50% 6–8 Capsule (May open 10, 20, 30, 40,
and sprinkle beads 60 mg
on applesauce)
Metadate CD* Once daily 30% 70% 6–8 Capsule (May open 10, 20, 30, 40,
and sprinkle beads 50, 60 mg
on applesauce)
Metadate ER* Once daily 8 Tablet 10, 20 mg
QuilliChew ER Once daily 30% 70% 8 Chewable tablet 20, 30, 40 mg
(Cherry flavor)
Concerta* Once daily 22% 78% 10–12 Tablet (Swallow 18, 27, 36, 54 mg
whole)
Relexxii* Once daily 18% 72% 8–12 Tablet (Swallow 18, 27, 36, 45, 54,
whole) 63, 72 mg
Daytrana Once daily 10–12 Patch (Apply 2 10, 15, 20, 30 mg
(9 hr wear) hours prior to need
for effect)
Quillivant XR Once daily 20% 80% 12 Suspension 25 mg/5 mL
(Banana flavor)
Cotempla Once daily 25% 75% 12 Orally 8.6, 17.3, 25.9 mg
XR-ODT disintegrating
tablet (Dissolve
on tongue; Grape
flavor)
Aptensio XR Once daily 40% 60% 12 Capsule (May open 10, 15, 20, 30, 40,
and sprinkle beads 50, 60 mg
on applesauce)
Jornay PM Once daily in <5% 95+% 12 (begins Capsule (May open 20, 40, 60, 80,
pm (between 10 hr after and sprinkle beads 100 mg
6:30–9:30 pm) dose) on applesauce)
Adhansia XR Once daily 20% 80% 16 Capsule 25, 35, 45, 55,
(Discontinued 70, 85 mg
July 20, 2022)

Dexmethylphenidate Focalin XR* Once daily 50% 50% 8–12 Capsule (May open 5, 10, 15, 20, 25,
and sprinkle beads 30, 35, 40 mg
on applesauce)
 erdexmethylphenidate/ Azstarys
S Once daily 30% 70% 13 Capsule (May 26.1–5.2, 39.2–
dexmethylphenidate open and sprinkle 7.8, 52.3–10.4 mg
in 2 oz water or
applesauce)
* Generic available in certain strengths.

in the management of ADHD and other conditions. The of misuse, abuse, and addiction before prescribing
FDA is requiring updates to the boxed warnings and stimulant medications and throughout therapy. Refill
prominent wording across this medication class. Health requests should also be evaluated for appropriate
care professionals are urged to assess a patient’s risk timing. It is important to counsel patients to take their

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 ADHD Diagnosis and Treatment in the Pediatric Population Eiland, L et al

Table 3. Amphetamine-based Stimulants20–22,30–39

Medication Brand Name Frequency of Immediate Sustained Duration Formulation(s) Available
(US) Dosing Release/ Release/ of Strengths
First Dose Second Dose Action
Release Release (hr)

Immediate release
 ixed amphetamine
M Adderall* Once daily- 100% 4–6 Tablet 5, 7.5, 10, 12.5, 15,
salts TID 20, 30 mg
Amphetamine Evekeo* Once daily- 100% 4–6‡ Tablet (Slightly 5, 10 mg
TID bitter taste)
Evekeo-ODT Once daily- 100% 4–6 Orally dissolving 5, 10, 15, 20 mg
TID tablet (Slightly
bitter taste)
Dextroamphetamine Dexedrine/ BID-TID 100% 4–6 Tablet 5, 10 mg
DextroStat*
Zenzedi* BID-TID 100% 4–6 Tablet 2.5, 5, 7.5, 10, 15,
20, 30 mg
ProCentra* BID-TID 100% 4–6 Solution 5 mg/5 mL
(Bubblegum flavor)

Extended release
Mixed amphetamine Adderall XR* Once daily 50% 50% 10–12 Capsules (May 5, 10, 15, 20, 25,
salts open and 30 mg
sprinkle beads on
applesauce)
Mydayis Once daily 33.3%† 33.3%† 16 Capsules (May 12.5, 25, 37.5,
open and 50 mg
sprinkle beads on
applesauce)
Amphetamine Adzenys ER Once daily 50% 50% 10–12 Suspension 1.25 mg/mL
(3 dextro- to 1 (Orange flavor)
levo-isomer)
Adzenys XR-ODT Once daily 50% 50% 10–12 Orally 3.1, 6.3, 9.4, 12.5,
disintegrating 15.7, 18.8 mg
tablet (Dissolve on
tongue; Orange
flavor)
Dyanavel XR Once daily 13 Suspension 2.5 mg/mL
(3.2 dextro- to (Bubblegum flavor)
1 levo-isomer)
Dyanavel XR Once daily 13 Tablet (Bubblegum 5, 10, 15, 20 mg
(3.2 dextro- to flavor)
1 levo-isomer)
Dextroamphetamine Dexedrine Once daily- 6–8 Capsule (May open 5, 10, 15 mg
Spansule* BID and mix with soft
food)
Xelstrym Once daily 9 Patch (Apply 2 4.5, 9, 13.5,
(9 hr wear) hours prior to need 18 mg
for effect)
Lisdexamfetamine Vyvanse Once daily 10–12§ Capsule (May 10, 20, 30, 40,
open and mix with 50, 60, 70 mg
orange juice, water,
or yogurt)
Vyvanse Once daily 10–12 Chewable tablet 10, 20, 30, 40,
(Strawberry flavor) 50, 60 mg
ODT, oral dissolving tablet

* Generic available in certain strengths.

† 3 bead system: 33.3% at each release.
‡ BID dosing resulted in efficacy for a 10-hour duration.30
§
Adult study determined efficacy for up to 14 hours duration.39

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Eiland, L et al ADHD Diagnosis and Treatment in the Pediatric Population

Table 4. Recommended Monitoring for Stimulant Medications7,12,18,40

Monitoring Variable Frequency of Monitoring Comments

Blood pressure (BP) Baseline (prior to stimulant Further evaluation and/or therapy modifications
initiation), each follow-up needed with a systolic BP ≥ 95th percentile or
visit (every 3–6 months), BP ≥ 130/80 on 2 or 3 occasions
and after any dose change

Heart rate Baseline (prior to stimulant Therapy modifications needed with a sustained
initiation), each follow-up resting tachycardia (> 120 beats per minute) or
visit (every 3–6 months), arrhythmia
and after any dose change

Height, weight, body mass index Baseline (prior to stimulant Options to assist with weight loss or poor growth
initiation) and each follow- include administer medication at or after meal, offer
up visit (every 3–6 months) additional meals or snacks early in the morning or
late in evening after stimulants effects have worn off,
consume high-calorie dense foods of good nutritional
value, obtain dietary advice from a dietician, consider
a drug holiday, change medication

Electrocardiogram (ECG) Not routinely ECG and cardiology referral recommended if any
recommended of the following apply: history of congenital heart
disease or previous cardiac surgery, history of
sudden death in first-degree relative before age
40 yr, shortness of breath or fainting on exertion,
palpitations that are rapid, regular and start and stop
suddenly, chest pain, signs of heart failure, murmur on
cardiac exam, hypertension

medication as prescribed, not to share their medica- tablet shell does not dissolve completely and may be
tions with others, how to properly store and dispose seen intact in the stool. Additionally, the tablet does not
of unused medication, and on signs and symptoms of change shape and thus, should not be used in patients
non-medical use, addiction, and drug diversion. Signs with preexisting severe gastrointestinal narrowing.24
and symptoms of stimulant overdose should also be Another important note is that most products are not in-
reviewed with the patient and caregivers including terchangeable due to pharmacokinetic properties and
when to seek emergency care. dosage formulations and require a taper off/on when
Methylphenidate Formulations. Methylphenidate- a shift of agents is necessary. Lastly, it is important to
based stimulants represent a common starting point verify therapeutic equivalence with the FDA Orange
for the medication management of ADHD in younger Book for generic stimulant products.
children. The AAP recommends it for preschool chil- A published pharmacological review has detailed
dren after behavioral therapy.7 The NICE recommends characteristics of earlier products available for ADHD
starting with this class of stimulants when ADHD symp- treatment.42 Since 2018, at least 3 new medications
toms persist after environmental modifications in chil- have joined the methylphenidate class. These new
dren and young people.12 Methylphenidate products dosage forms seek to increase the functionality of the
are listed in Table 2.20–29 US Food and Drug Administra- class. They include a first-in-class prodrug formulation,
tion approval for each product varies per age. Medica- another multilayer beaded long-acting formulation, and
tion formulations range from immediate release (3- to a distinctive delayed-release/extended-release product
5-hour duration of action) to extended release (8- to design. All 3 are capsules with a long duration of action
13-hour duration of action). Brand name products fall allowing for once-daily dosing.
into the methylphenidate, dexmethylphenidate, and Approved in March 2021, Azstarys capsules contain
serdexmethylphenidate categories. Product formulations
­
dexmethylphenidate and serdexmethylphenidate in a
include tablets, capsules, chewable tablets, orally dis- fixed molar ratio of 30%/70%, respectively.21,29 The pro-
solving tablets, solutions, suspensions, and a transder- drug component, serdexmethylphenidate, undergoes
mal patch. Generic product options are available for bioactivation in the lower GI tract. The unique formu-
several agents in this class, representing more cost- lation allows for continuous conversion to dexmethyl-
effective options. Patient education regarding unique phenidate providing extended concentrations (up to
dosage forms is imperative. For example, Concerta has 13 hours) of active drug throughout the course of ther-
an osmotic-controlled release methylphenidate tablet apy. The capsules are offered in 3 distinctive strengths.
shell that allows for a slow, controlled release.42 Yet, the The medication can be taken with or without food and

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ADHD Diagnosis and Treatment in the Pediatric Population Eiland, L et al

Jornay PM represents a new methylphenidate

Table 5. Stimulant Adverse Events and ­Management7,18
formulation, a delayed-release/extended-release cap-
Adverse Event Potential Management Options sule.28 Approved by the FDA in August 2018, Jornay
Sleep disturbance Behavioral measures (sleep
PM is recommended for patients ≥6 years of age.21 The
hygiene), dosage reduction, product is manufactured in 5 unique strengths ranging
administer dose earlier in day, from 20 to 100 mg.28 Like other ADHD medications,
alternative stimulant formulation capsules may be opened for administration, without
or class, change to or add-on a crushing or chewing the capsule contents. Of impor-
non-stimulant option tance, transitioning between Jornay PM and other
Decreased appetite See weight monitoring in Table 4 methylphenidate products is not on a milligram-to-
milligram exchange based on formulation and release
Increased blood See BP and HR monitoring in mechanism differences. Jornay PM is unique in that it
pressure (BP) or Table 4 is taken in the evening, representing the first and only
heart rate (HR)
product in the stimulant class with this specific time
Dizziness Monitor BP and HR, ensure of administration. Timing of the evening dose (6:30 to
adequate fluid intake, consider 9:30 pm) is recommended to optimize the efficacy and
longer-acting preparation tolerability of the medication for the subsequent day.
Rebound ADHD Increase dose of long-acting In children 6 to 12 years of age, 8 pm was found to be
symptoms agent or add smaller dose of the optimal timing of administration. Pharmacokinetic
short-acting medication before properties of Jornay PM show that ≤5% of the total
when rebound symptoms appear drug dose is released within the first 10 hours after
dosing. Following this time, methylphenidate absorp-
Tics Dosage reduction, change to non-
tion occurs with a single peak and a median maximum
stimulant option, stop offending
medication concentration time of 14 hours. Jornay PM is marketed
to improve the morning routine in patients with ADHD
Suicidality and Verify appropriate dose is and subsequently to continue control for the dosing
psychosis administered as prescribed, duration. Another potential benefit of this product is
reduce dose, discontinue
to assist patients who struggle with morning medica-
stimulant, screen for safety/refer
to specialist
tion adherence. Due to its long duration, insomnia is
the most common adverse effect (33%–41%) of this
Diversion and Monitor prescription refills, product in pediatric patients.28
misuse open discussions with patient/ Amphetamine Formulations. Amphetamine-based
caregiver, avoid co-use with
stimulants represent a preferred ADHD treatment op-
alcohol, tobacco, marijuana, and
tion for children, adolescents, and adults. NICE recom-
other illicit substances, proper
medication storage and disposal mends this class as a second-line agent in children,
behind methylphenidate.12 In contrast, the AAP does
not differentiate among stimulant classes, thus includ-
is FDA-approved for patients ≥6 years of age. Capsules ing amphetamine formations as a first-line option.7
can be consumed whole, opened onto applesauce, or Comparing the two stimulant classes, amphetamines
mixed with 50 mL water. Opened capsules must be are associated with greater adverse effects and ad-
taken within 10 minutes of mixing. Due to its prolonged verse events.17 Amphetamine products are listed in
duration of action, Azstarys is given once daily in the Table 3.20–22,30–39 Medication formulations range from
immediate release (4- to 5-hour duration of action) to
morning. Adverse effects are like other products in
extended release (8- to 16-hour duration of action).
the class, with the most common being insomnia and
Brand name products fall into the mixed amphetamine
suppressed appetite.
salts, amphetamine, dextroamphetamine, and lisdex-
Adhansia XR was FDA-approved in February 2019,
amfetamine categories. Product formulations include
yet was discontinued by the manufacturer in July tablets, capsules, chewable tablets, orally disintegrat-
2022.21,27 Per the manufacturer, the product discon- ing tablets, solutions, suspensions, and a newly ap-
tinuation was a business decision and not based on proved transdermal patch. Generic product options
efficacy or safety concerns.43 Authorized for patients are available for several agents in this class, once
≥ 6 years, the product represented another encapsu- again representing more cost-effective options.
lated beaded long-acting methylphenidate formula- Xelstrym (dextroamphetamine) was FDA-approved
tion.27 The significant advantage for Adhansia XR was in March 2022.37 Indicated for patients ≥ 6 years, this
its lengthy duration of action (roughly 16 hours). This product represents the only transdermal amphetamine
formulation represented the longest interval product patch formulation. Xelstrym was studied in children
in the methylphenidate class. < 6 years, yet long-term weight loss was an u­ ndesirable

114 J Pediatr Pharmacol Ther 2024 Vol. 29 No. 2 www.jppt.org

Eiland, L et al ADHD Diagnosis and Treatment in the Pediatric Population

adverse event. The patch formulation is available in recommendations for both children 6 to 11 years and
4 strengths (4.5 mg/9 hr, 9 mg/9 hr, 13.5 mg/9 hr, and adolescents 12 to 17 years of age.7 Additionally, NICE
18 mg/9 hr). Xelstrym must be applied 2 hours before includes the use of the non-stimulants as treatment
the anticipated effect is necessary and subsequently options for pediatric patients ≥ 5 years and adults.12
removed within 9 hours. Patch site rotation is also The non-stimulant agents are recommended in pa-
imperative. The external application of heat will in- tients whose symptoms do not respond to either stim-
crease drug absorption, and counseling needs to be ulant compound or in situations of concern regarding
provided to avoid heat usage. Xelstrym should not be abuse or diversion with the stimulant class.7
exchanged for other amphetamine formulations based Norepinephrine Reuptake Inhibitors. Atomoxetine
on dosing. Decreased appetite, headache, insomnia, and viloxazine selectively inhibit norepinephrine trans-
and abdominal pain are a few adverse effects found porters, thus increasing extracellular synaptic con-
with Xelstrym treatment. centrations of norepinephrine and dopamine in the
In September 2017, Adzenys ER extended-release ­prefrontal cortex.18,21,22 Unlike the stimulant class, these
amphetamine suspension was FDA-approved for pa- agents take approximately 1 to 2 weeks to see an ini-
tients ≥6 years with ADHD.34 The suspension contains tial benefit with 4 to 6 weeks to see the maximal effect
a mixture of 50%/50% uncoated immediate-release on core ADHD symptoms. Atomoxetine is manufac-
microparticles to film-coated microparticles that delays tured as a capsule in 7 strengths, available in g ­ eneric
the absorption of amphetamine. Unlike other stimu- form, and is dosed once daily.45 Similarly, viloxazine is
lant preparations, Adzenys has published equivalent delivered once daily in a capsule formulation.46 Both
conversion doses to and/or from Adderall XR (mixed agents hold a boxed warning for suicidal ideation in
amphetamine salts). For illustration, an Adderall XR children and adolescents and use within 14 days of a
dose of 20 mg would be analogous with an Adzenys ER monoamine oxidase inhibitor is contraindicated. Ato-
suspension dose of 12.5 mg based on medication phar- moxetine is metabolized by CYP2D6.45 Patients who
macokinetic properties. The Adzenys ER suspension is are poor metabolizers of CYP2D6 may have a 5-fold
distributed in a 1.25-mg/mL concentration and holds a increase in peak plasma concentrations, 10-fold higher
duration of action of approximately 10 to 12 hours. A key area under the curve, and half-life of 24 hours, thus
advantage of Adzenys ER is the suspension delivery slower elimination of the drug. While atomoxetine is not
formulation, which allows for ease of administration in a CYP2D6 inducer or inhibitor, dose adjustments may
patients unable to swallow a tablet or capsule. be warranted in extensive and poor metabolizer when
Mydayis, as mixed amphetamine salts, was FDA- administered with CYP2D6 inhibitors. Blood pressure
approved in June 2017.33 This long-acting formula- and heart rate should also be monitored in patients
tion includes 3 forms of drug-releasing beads, an taking atomoxetine and antihypertensives and pres-
immediate-release and 2 separate delayed-release sor agents or systemic albuterol due to cardiovascular
beads that represent a 3:1 ratio of d-amphetamine and effects. Viloxazine is a strong inhibitor of CYP1A2 and
l-amphetamine. Like other capsule preparations, the weak inhibitor of CYP2D6, and CYP3A4.46 Sensitive
contents can be mixed in applesauce for delivery, tak- CYP1A2 substrates and CYP1A2 substrates with a nar-
ing caution to not crush or chew. Mydayis is authorized row therapeutic index are contraindicated with viloxa-
for adolescents (≥13 years of age) and adults only. In zine use, and moderately sensitive CYP1A2 substrates
studies with children <13 years at comparable doses, el- are not recommended for coadministration. Patients
evated plasma levels were found that equated to higher who are poor CYP2D6 metabolizers have higher peak
rates of insomnia and decreased appetite. Mydayis is concentrations and area under the curve of viloxazine
formulated in 4 dosage concentrations. Due to the long compared with extensive metabolizers. Pharmacoge-
duration of action (up to 16 hours), early morning medi- nomic testing of patients may be considered prior to
cation administration is imperative. When contrasted use of this medication class.
with other mixed amphetamine salts formulations, a Alpha-2 Agonists. Guanfacine and clonidine ex-
single dose of Mydayis 37.5 mg supplied similar plasma tended-release formulations have FDA approval for
concentration profiles to the blend of a 25-mg mixed the management of ADHD in children and adoles-
amphetamine salts extended-release capsule followed cents as either monotherapy or in combination with
by a 12.5-mg immediate release dosage form 8 hours another FDA-approved medication class.18,21,22 The
after. Mydayis extended-release capsules are the immediate-release formulations of guanfacine and
lengthiest duration amphetamine-based formulation clonidine may also be used off-label. These agents
on the market and have a longer duration than any work by stimulating postsynaptic alpha-2-adrenergic
currently available methylphenidate product. receptors. The extended-release agents are both in
Non-stimulants. There are 4 non-stimulant medi- tablet formulation, available in generic formulation,
cations, 2 unique drug classes, with FDA approval and are dosed once daily in the morning. Both agents
for the management of ADHD (Table 6).20–22,44–46 The hold warnings for hypotension, bradycardia, synco-
AAP guidelines include both classes in their treatment pe, sedation, somnolence, and dry mouth. It is also

www.jppt.org J Pediatr Pharmacol Ther 2024 Vol. 29 No. 2 115

ADHD Diagnosis and Treatment in the Pediatric Population Eiland, L et al

Table 6. Non-stimulant Treatment Options20–22,44–46

Medication Brand Frequency Formulation(s) Available Warnings/Precautions
Name (US) of Dosing Strengths

Norepinephrine reuptake inhibitors

Atomoxetine Strattera* Once daily Capsule (Swallow 10, 18, 25, 40, Suicidal ideation in children/
whole, do not 60, 80, 100 mg adolescents
open) Severe liver injury
Serious cardiovascular events
Viloxazine Qelbree Once daily Capsule (May 100, 150, 200 Suicidal ideation in children/
open and mg adolescents
sprinkle on Blood pressure and heart rate
pudding or changes
applesauce; do Activation of mania/hypomania
not chew) Somnolence/fatigue

Alpha-2 agonists
Guanfacine ER Intuniv* Once daily Tablet 1, 2, 3, 4 mg Hypotension, bradycardia,
syncope
Sedation/somnolence
Clonidine ER Kapvay* Once daily Tablet 0.1 mg Hypotension, bradycardia,
syncope
Vascular disease, cardiac
conduction disease, or chronic
renal failure
Sedation/somnolence
Abrupt discontinuation
concerns
ER, extended release

* Generic available in certain strengths.

i­mportant to educate the patient/caregiver that these adolescents, and adults with ADHD.17 Both bupropion
agents should not be stopped abruptly to the risk of and modafinil were found to be more efficacious than
rebound hypertension. If a patient encounters repeat- placebo. Yet the authors note a large confidence interval
ed orthostasis or fainting, a reduction in dose or ther- in relation to the efficacy and tolerability of both agents
apy change is warranted. As with the norepinephrine and recommend caution with interpreting the data. In
reuptake inhibitors, clinical response may be delayed the end, more information is needed with these agents
with a maximal effect seen at 2 to 4 weeks of therapy. in the treatment of pediatric ADHD.

Off-Label Pharmacologic Treatment Conclusion

Options ADHD is a common disease practitioners encounter
Off-label treatment options for the management of in the pediatric population. Behavioral therapy and/or
ADHD in children have been studied. One agent in- stimulant medication remain the first-line treatment
vestigated in both children and adults is bupropion. It recommendations. Stimulant products differ based
holds a parallel mechanism of action and is structurally on pharmacokinetic profile and dosage formulation.
similar to the stimulant class.47 However, the medication Additionally, new stimulant products as well as non-
is contraindicated in patients with a seizure disorder or stimulants continue to receive approval for use in the
in patients with a coexisting condition that may put them pediatric population and drug shortages can impact
at risk for seizures (e.g., bulimia nervosa).21,22 Bupropion prescribing. Pharmacists can educate other health
also carries the antidepressant-class warning of suicidal care providers on the similarities and differences of
ideation in children and adolescents. Another agent ADHD medication to improve the efficacy and safety
studied off-label for ADHD is modafinil. The current la- of therapy for the patient.
beled use for modafinil is excessive daytime sleepiness
related to narcolepsy, obstructive sleep apnea, or shift Article Information
work sleep disorder.22 The exact mechanism of modafinil Affiliations. Department of Pharmacy Practice (LSE), Auburn
is unclear, but it maintains links to dopamine similar to University Harrison College of Pharmacy; Department of Phar-
amphetamine. A network meta-analysis looked at the ef- macy Practice (BLG), Southwestern Oklahoma State University
ficacy and tolerability of various medications for children, College of Pharmacy.

116 J Pediatr Pharmacol Ther 2024 Vol. 29 No. 2 www.jppt.org

Eiland, L et al ADHD Diagnosis and Treatment in the Pediatric Population

Correspondence. Lea S. Eiland; eilanls@auburn.edu 13. Canadian ADHD Resource Alliance (CADDRA). Canadian
ADHD Practice Guidelines, Fourth Edition. Toronto, ON,
Disclosure. The authors declare no conflicts or financial inter- Canada: CADDRA; 2018.
est in any product or service mentioned in the manuscript, 14. Peñuelas-Calvo I, Jiang-Lin LK, Girela-Serrano B, et
including grants, equipment, medications, employment, gifts, al. Video games for the assessment and treatment of
and honoraria. attention-deficit/hyperactivity disorder: a systematic
review. Eur Child Adolesc Psychiatry. 2022;31(1):5–20.
Submitted. April 20, 2023 15. Oh S, Choi J, Han DH, Kim E. Effects of game-based digital
therapeutics on attention deficit hyperactivity disorder
Accepted. July 19, 2023 in children and adolescents as assessed by parents or
teachers: a systematic review and meta-analysis [pub-
Copyright. Pediatric Pharmacy Association. All rights reserved. lished online ahead of print March 2, 2023]. Eur Child
For permissions, email: membership@pediatricpharmacy.org Adolesc Psychiatry. doi:10.1007/s00787-023-02174-z
16. US Food and Drug Administration. FDA permits market-
ing of first game-based digital therapeutic to improve
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