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A Guide to Psychopharmacology for Pediatricians

In 2009, the American Academy of Pediatrics called on pediatric primary care providers to help start the treatment process for children with the most common mental illnesses in that age group: attention-deficit/hyperactivity disorder (ADHD), anxiety, depression, and substance abuse.  For some children struggling with these conditions, psychiatric medications can play an important role in their care.

Part of the Center's mission is to make knowledge from the mental health community more available to the pediatric primary care clinician.  Under the direction of Mark Riddle, MD, and Susan dosReis, PhD, Center faculty are developing guidelines to aid primary care providers in selecting psychiatric medications to treat attention-deficity/hyperactivity disorder, anxiety, and depression.

This page presents an overview of the Center's conceptual framework and selection criteria for psychiatric medications that are appropriate for prescribing in primary care.  It also includes guidelines to eight medications primary care providers could prescribe and a list of 22 additional psychiatric medications whose use clinicians can monitor in their patients.  Finally, the page discusses other issues associated with prescribing psychiatric medications and lists some additional resources.

This is a work in progress, and we welcome feedback.  Information provided here is intended to guide decision-making, not as a substitute for clinical judgment.  The tables and other content were developed by reviewing available literature (current as of spring 2011) and FDA package inserts and consulting subject matter experts.  The page provides links to key references.  The Center will provide a complete list of references for this page upon request.

To get started, scroll down or click on any subject header below:

Conceptual framework and criteria for selecting specific medications

In considering psychiatric medications that would be most appropriate for primary care clinicians to prescribe, Center faculty assessed medications for effectiveness, ease of dosing/monitoring, and safety based on the following criteria:

For effectiveness:

  • Medications must perform better than placebos in at least two double-blinded clinical trials using standard outcome measures in children.

For dosing and monitoring:

  • Medication dosing guidelines should be reasonably established and not require intensive monitoring.
  • Any necessary somatic monitoring should be limited to vital signs, height, and weight.
  • Side effects should be detectable, predictable, and readily manageable in primary care.

For safety:

  • Medications should have FDA approval — a sign that research supports at least its short-term safety and efficacy.
  • There should be minimal concern about boxed warnings — the FDA's strongest warning level short of taking a medication off the market.
  • Medications should be on the market for at least 10 years — more time means more opportunity to discover rare complications and adverse effects.
  • Medications should have minimal harm from overdose — this is determined by reviewing available literature and reports.
  • Medications should have minimal potential for irreversible long-term harm — this is determined by reviewing available literature and reports.

Four classes of psychiatric medications meet the criteria for effectiveness, dosing and monitoring, and safety: stimulantsalpha-2adrenergic agents, serotonin and norepinephrine reuptake inhibitors (SNRIs), and selective serotonin reuptake inhibitors (SSRIs). Download tables detailing evidence supporting the safety and efficacy of each class.

Guide to 8 medications for prescribing

Within the four drug classes, eight specific medications met each of the effectiveness, dosing and monitoring, and safety criteria.  The table below gives more information about each medication and its proposed use in pediatric populations: ADHD, anxiety, or major depressive disorder (MDD).  The table also notes whether the proposed use matches the FDA indication for the medication in youth.  For example, the FDA has not officially approved any medication for anxiety in pediatric patients, but prescribing SSRIs for certain forms of childhood anxiety is considered community standard.  Each medication listed below will be available in generic form by 2012.   

Drug (class)Trade names
Proposed use in primary care
FDA indication?
Methylphenidate (stimulant)Ritalin, Concerta and others
ADHD
Yes
Amphetamines (stimulants)Dexedrine, Adderall and others
ADHD
Yes
Guanfacine (alpha-2A adrenergic agonist)Tenex, Intuniv
ADHD
Yes
Clonidine (alpha-2 adrenergic agonist)Catapres, Kapvay
ADHD
Yes
Atomoxetine (SNRI)Strattera
ADHD
Yes
Fluoxetine (SSRI)Prozac
Anxiety*
MDD
No
Yes
Sertraline (SSRI)Zoloft
Anxiety*
MDD**
No
No
Escitalopram (SSRI)Lexapro
Anxiety
MDD
No
Yes

*Though the FDA has not officially approved fluoxetine and sertraline for treating anxiety disorders such as social phobia, separation anxiety, or generalized anxiety disorders, there is convincing evidence for using these medications for these disorders.
** Sertraline has some evidence supporting its use in MDD, but not enough evidence to support an FDA indication.

Adverse events

The eight medications above were selected with safety in mind, but clinicians should always be aware of potential adverse events associated with their use.  The FDA lists adverse events associated with medications in order of severity.  Here, we present a table of adverse events for the medications organized by frequency — most commonly seen, less commonly seen, and rare adverse events  — as another resource for providers.  The table groups medications by class, as all medications within a class will share similar adverse events.  All the medications except fluoxetine and atomoxetine should be tapered to minimize withdrawal symptoms.  A PDF of the withdrawal symptoms by medication and recommendations for vital signs to monitor in youth starting these medications is available.

Medication class: Generic name
Common adverse events
Less common    adverse events
Rare eventsMonitor
Stimulants:
Methylphenidate, dextroamphetamine, amphetamine salts
Insomnia, appetite suppression, headache, stomachache
Cognitive dulling, irritability, exacerbation   of tics (controversial)
Growth retardation, hallucinations (visual or tactile, auditory less common), arrhythmia in those with preexisting cardiac diseaseBP, P, BMI
alpha-2adrenergic agonists: Guanfacine, clonidine
Somnolence
Dry mouth, headache, nausea, decreased blood pressure
Elevated blood pressure, nervousness, headache, confusionBP, P
SNRI: Atomoxetine
Dry mouth, insomnia, nausea, decreased appetite
Increased heart rate and blood pressure, palpitations, dizziness, sweating, dysuria, weight change
NoneBMI, BP, HR
SSRIs: Fluoxetine, sertraline, escitalopram"Activation" (restlessness, insomnia, impulsiveness, talkativeness — usually occurs early in treatment) without mood elevation, gastrointestinal upset, nausea, diarrheaDiaphoresis, mydriasis, flushing, sinus tachycardia, hypertension, decreased libido, delayed ejaculation, akathisia
Serotonergic syndrome,* agitation, ataxia, diaphoresis, diarrhea, hyper-reflexia, mental state changes, myoclonus, shivering, tremor, hyperthermia neuroleptic malignant syndrome, suicidal thinking or behavior, true mania emergence, usually by 4th week of treatment
BMI, suicidality, activation**

*Serotonergic syndrome may be potentiated by drug interaction with other pro-serotoninergic agents (eg, MAOIs, trazodone, lithium, opioids, amphetamine/stimulants, cocaine, St John’s Wort, or ginseng)
**Clinicians should monitor youth specifically for worsening of depression, emergence of suicidal thinking, or behavior, especially with initiation or dose escalation, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations

Boxed warnings

The FDA has issued boxed warnings for a few of the eight medications.  The warning for SSRIs and SNRIs says "antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults."  In practice, antidepressant-induced suicidality seems rare.  A recent survey of data from 27 randomized clinical trials involving more than 5,300 participants found a 0.7 percent increase in risk of suicidality among youth taking antidepressants versus those taking placebos.  In 2007, the FDA released a guide for parents with more information about monitoring for signs of suicidality among youth taking antidepressants.

Amphetamines carry a boxed warning that states "misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions."  Clinicians should be sure to take a youth's personal and family cardiac history — with specific questions about syncope, sudden unexplained death, and arrhythmias — before prescribing a stimulant.

The boxed warnings for both amphetamine and methylphenidate preparations warn about their high potential for abuse and dependence after prolonged administration, though there are no reports of children developing dependence after taking therapeutic doses.  Children treated with stimulants for ADHD have increased risk of having substance abuse problems later in life than those who did not take stimulants.  Finally, there is concern about youth selling prescription stimulants to others who might abuse them, a practice known as diversion.

Guide to 22 medications for monitoring only

Some medications should only be prescribed by those with specific mental health expertise due to complicated dosing regimens, potential for side effects, and/or other concerns.  But primary care clinicians can still play an important role in monitoring patients prescribed these medications.  The medications are described by class below.  Additional details about the medications, their uses and adverse effects are available for download.

Medication classMedications
SSRIsFluvoxamine, citalopram, paroxetine
SNRIVenlafaxine
Tricyclic antidepressantsNortriptyline, clomipramine
Other antidepressantsBupropion, mirtazepine
AnxiolyticsBuspirone, lorazepam and clonazepam (benzodiazepines)
Second generation antipsychoticsRisperidone, quetiapine, aripiprasole, ziprazidone, olanzapine
First generation antipsychoticsPerphenazine, haloperidol
Mood stabilizersLithium, valproic acid, carbamazepine/oxycarbamazepine, lamotrigine

Other issues

Informed consent

Though the process of obtaining informed consent/assent for psychiatric medications is the same as for any other treatment, youth and their families may have additional questions about these medications.  Media coverage of SSRIs and their link to increased suicide risk, and the medications' potential to affect the brain can add to concerns.  Providers should be mindful of these issues and prepare to revisit consenting as the treatment plan evolves.  Download a discussion guide for seeking informed consent for psychiatric medications.

Multiple medications

Most children will require only one psychiatric medication.  When necessary, providers can safely prescribe methylphenidate, amphetamine, guanfacine, or atomoxetine in combination with fluoxetine, sertraline, or escitalopram to treat comorbid ADHD and depression or anxiety.  Primary care clinicians should consult with mental health specialists when a youth requires three or more medications.

Resources

  •  The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a public-access, brief screen for depressive symptoms. 
  • The CRAFFT is a public-access, brief screen for adolescent substance abuse.
  •  Youth in the child welfare system may have unique needs for therapy treatment.  Providers can access The California Evidence-Based Clearinghouse for Child Welfare website to review the evidence base for psychosocial interventions specifically evaluated for youth in child welfare. This information can be utilized to guide therapy referrals.
  • The National Institute of Mental Health-Life Charting Method facilitates prospective tracking of medication adherence, mood symptoms (activation vs. depression), sleep, suicidality, and new stressors.
  •  The United States Department of Agriculture's MyPlate website has resources for tracking diet and activity.
  • The Centers for Disease Control and Prevention offers a simple BMI calculator on its website.