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Appendix

Psychotropic Medications Commonly Prescribed for Children and Adolescents

This appendix describes common classes of psychotropic medications used to treat children and adolescents. Dosing information, monitoring schedules, and common side effects are presented for each medication class.

Antidepressants

Dosage and Monitoring

The starting dosages and target dosages of antidepressants for children and adolescents are listed in Table 55–1.

TABLE 55–1. Clinical use of antidepressants in children and adolescents

	Typical starting dose (mg)
Medication	Child	Adolescent	Target dosage (mg/day)
Selective serotonin reuptake inhibitors
Citalopram	5–10	10	20–40
Escitalopram	5	10	10–20
Fluoxetine	5–10	10	20–40
Paroxetine	5–10	10	20–40
Sertraline	25	50	100–200
Mirtazapine	15	15	30–45
Venlafaxine	37.5	37.5	150–225
Bupropion	50 bid	50 bid	100–200
Duloxetine	30	30	60–120
Note. bid=twice daily.

Premedication laboratory testing should include complete blood count, blood chemistries, and liver function tests. Blood pressure should be monitored during dosage titration with venlafaxine.

The U.S. Food and Drug Administration (2007) issued the following black box warning, which applies to all antidepressants:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Name of Antidepressant] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24 years; there was a reduction in risk with antidepressants compared with placebo in adults ages 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Side Effects

Common side effects of selective serotonin reuptake inhibitors (SSRIs) are headache, nausea, abdominal pain, dry mouth, insomnia, and somnolence (Emslie et al. 2002; Keller et al. 2001; Wagner et al. 2003a, 2004b, 2006a). Potential serious adverse events include serotonin syndrome, extrapyramidal side effects (EPS) (tics, myoclonus), amotivational syndrome, and increased bleeding (Hammerness et al. 2006). A major advantage of SSRIs is their safety in overdose (Barbey and Roose 1998).

Common side effects of mirtazapine are somnolence, increased appetite, weight gain, dizziness, dry mouth, and constipation (Green 2001).

Common side effects of venlafaxine include anorexia, abdominal pain, insomnia, somnolence, dizziness, dry mouth, increased sweating and nervousness, and elevated blood pressure with dosage increase (Emslie et al. 2007; Green 2001).

Common side effects of bupropion are headache, nausea, rash, irritability, drowsiness, fatigue, and anorexia (Barrickman et al. 1995; Conners et al. 1996; Daviss et al. 2001). Bupropion is contraindicated in children with seizure disorders, because it may lower the seizure threshold.

Common side effects of duloxetine are nausea, vomiting, nasopharyngitis, abdominal pain, headache, and somnolence (Atkinson et al. 2014; Emslie et al. 2014).

Atomoxetine

Dosage and Monitoring

Atomoxetine can be taken in the late afternoon or evening, whereas stimulants generally cannot; atomoxetine may have less pronounced effects on appetite and sleep than stimulants, although it may produce relatively more nausea or sedation. Gastrointestinal distress can be minimized by taking the medication after a meal. In children and young adolescents, atomoxetine is initiated at a dosage of 0.3 mg/kg/day and titrated over 1–3 weeks to a maximum dosage of 1.2–1.8 mg/kg/day (Kratochvil et al. 2003). In adults or adult-sized adolescents, atomoxetine should be started at 40 mg/day and titrated to 80–100 mg/day over 1–3 weeks, if needed (Kratochvil et al. 2003). Atomoxetine’s labeling recommends both once-daily and twice-daily dosing, although its elimination half-life of 5 hours (as well as clinical experience) suggests that twice-daily dosing (early morning and early evening) is more effective and less prone to cause side effects. Michelson et al. (2002) showed that although atomoxetine was superior to placebo at week 1 of the trial, its greatest effects were observed at week 6, suggesting that patients should be maintained at the full therapeutic dosage for at least several weeks for the drug to reach its full effects.

Side Effects

Side effects that occurred at higher rates with atomoxetine than with placebo in clinical trials included gastrointestinal distress, sedation, and decreased appetite. These can generally be managed by dosage adjustment and often attenuate with time. In December 2004, the FDA announced a new warning for atomoxetine due to reports of two patients (an adult and a child) who developed severe liver disease (U.S. Food and Drug Administration 2004c). Both patients recovered. The FDA has also issued an alert regarding suicidal thinking with atomoxetine in children and adolescents (U.S. Food and Drug Administration 2005). A black box warning is included in the package insert. In 12 controlled trials involving 1,357 patients receiving atomoxetine and 851 receiving placebo, the average risk of suicidal thinking was 4 per 1,000 patients in the atomoxetine-treated group versus none in the placebo group.

Atypical Antipsychotics

Dosage and Monitoring

Usual starting dosages and target dosages of atypical antipsychotics are listed in Table 55–2.

TABLE 55–2. Clinical use of atypical antipsychotics in children and adolescents

Medication	Typical starting dose (mg)	Target dosage (mg/day)
Clozapine	25 bid	200–400
Olanzapine	2.5 bid	10–20
Quetiapine	50 bid	400–600
Risperidone	0.25 bid	1–2
Ziprasidone	20 bid	80–120
Aripiprazole	2.5–5.0 hs	10–25
Asenapine	2.5 sublingually bid	2.5–10 sublingually bid
Paliperidone ER
Weight <51 kg	3	3–6
Weight ≥51 kg	3	3–12
Note. bid=twice daily; ER=extended release; hs=at bedtime. Source. DelBello et al. 2006.

Premedication laboratory testing should include complete blood count, blood chemistries, and liver function tests. In addition, the recommendations of the American Diabetes Association et al. (2004) should be followed. These include baseline BMI, waist circumference, blood pressure, and fasting glucose and lipid panels. BMI should be followed monthly for 3 months and then measured quarterly. Blood pressure, fasting glucose, and lipid panels should be followed up at 3 months and then yearly. Monitoring should also be done for EPS.

Side Effects

Side effects of atypical antipsychotics include weight gain, dyslipidemia, insulin resistance and diabetes, hyperprolactinemia, EPS and akathisia, QTc prolongation, sedation, liver toxicity, neutropenia, and neuroleptic malignant syndrome. Clozapine has also been associated with seizures, agranulocytosis, and myocarditis (Correll et al. 2006).

Clonidine

Dosage and Monitoring

Clonidine is initiated at 0.05 mg/day, with dosage increases of 0.05 mg every 3 days. Typical dosages for attention-deficit/hyperactivity disorder (ADHD) are in the range of 0.15–0.3 mg/day (on a three-times-per-day schedule). Transdermal clonidine delivers dosages of 0.1, 0.2, or 0.3 mg/day. During initial treatment, a temporary worsening of motor and phonic tics in Tourette syndrome may occur, which usually resolves within 2–4 weeks. Clonidine should be tapered by 0.05 mg/day during discontinuation (Hunt et al. 1990).

Due to reports of adverse cardiovascular side effects in children taking clonidine, recommendations have been made regarding cardiovascular monitoring (Cantwell et al. 1997). Pulse and blood pressure should be measured at baseline, weekly during dosage titration, and every 4–6 weeks during maintenance treatment. Electrocardiograms (ECGs) should be obtained at baseline and after the maximum dosage of clonidine is achieved. Abrupt discontinuation of clonidine is not recommended, because it increases the risk of adverse cardiovascular side effects, particularly hypertension.

Side Effects

Common side effects of clonidine in children are sedation, depression, irritability, hypotension, sleep disturbance, dry mouth, and dizziness. Skin irritation and erythema are common with the clonidine patch (Connor et al. 1999; Hunt et al. 1990). Rebound tachycardia and hypertension may occur if clonidine is abruptly discontinued, particularly after chronic use (Popper 2000).

Safety concerns have been raised about the combination of clonidine and methylphenidate, following the report of four cases of sudden death in children taking this medication combination (Cantwell et al. 1997; Fenichel 1995). Swanson et al. (1995a) described two types of clonidine-related cardiovascular side effects. In one type, fatigue and sedation were associated with a decrease in pulse and blood pressure as well as changes in ECG. In the other type, tachycardia and tachypnea occurred, which led to anxiety, fever, and changes in mental status. Adverse cardiovascular side effects, including bradycardia and depressed level of consciousness, have been reported with clonidine overdose in children (Kappagoda et al. 1998). However, in a retrospective study of 42 children treated with clonidine alone or clonidine plus stimulants, no systematic effects were found on ECG parameters of pulse rate or QTc intervals (Kofoed et al. 1999).

Guanfacine

Dosage and Monitoring

Guanfacine is initiated at a daily dosage of 0.5 mg, with an upward titration of 0.5 mg every 3 days, based on clinical response and tolerability, to a maximum daily dosage of 4 mg (Hunt et al. 1995).

Pulse and blood pressure should be monitored during guanfacine treatment. Guanfacine should be tapered over a 4-day period upon discontinuation.

Side Effects

Common side effects of guanfacine in children are sedation, fatigue, headache, dizziness, stomachache, and decreased appetite (Chappell et al. 1995; Hunt et al. 1995; Melmed et al. 2006; Scahill et al. 2001). Rebound hypertension, nervousness, and anxiety may occur if guanfacine is abruptly discontinued (Green 2001).

Mood Stabilizers

Dosage and Monitoring

The starting dosages, target dosages, and therapeutic serum levels of mood stabilizers are listed in Table 55–3.

TABLE 55–3. Clinical use of mood stabilizers in children and adolescents

Medication	Typical starting dose (mg)	Target dosage	Therapeutic serum level
Carbamazepine	7 mg/kg/day	Based on response and serum level	8–11 μg/L
Lamotrigine	12.5 mg/day	Based on response	N/A
Lithium	25 mg/kg/day (2–3 daily doses)	30 mg/kg/day (2–3 daily doses)	0.8–1.2 mEq/L
Oxcarbazepine	150 mg bid	20–29 kg: 900 mg/day 30–39 kg: 1,200 mg/day >39 kg: 1,800 mg/day	N/A
Topiramate	25 mg/day	100–400 mg/day	N/A
Valproic acid, divalproex	20 mg/kg/day (2 daily doses)	20 mg/kg/day (2–3 daily doses)	90–120 μg/mL
Note. bid=twice daily; N/A=not applicable. Source. DelBello and Kowatch 2006.

Premedication laboratory testing in general should include complete blood count, liver function tests, and a pregnancy test (for females).

For lithium, baseline thyroid function tests, electrolytes, urinalysis, blood urea nitrogen, creatinine, and serum calcium should also be obtained. Lithium levels, renal function, thyroid function, and urinalysis should be monitored every 3–6 months.

For individuals taking divalproex, drug serum levels, complete blood count, and liver function tests should be monitored every 3–6 months. Because of concerns about a possible relationship between divalproex and polycystic ovarian syndrome (PCOS; Rasgon 2004), female adolescents taking divalproex should be monitored for signs of PCOS, including menstrual abnormalities, weight gain, acne, and hirsutism (DelBello and Kowatch 2006; McClellan et al. 2007). Parents and their female adolescents should be apprised about this possible association prior to initiating medication.

For oxcarbazepine, children should be monitored for hyponatremia.

Side Effects

Common side effects of lithium in children and adolescents include hypothyroidism, nausea, polyuria, polydypsia, acne, tremor, and weight gain (DelBello and Kowatch 2006).

Common side effects of divalproex in children and adolescents include weight gain, nausea, sedation, and tremor (DelBello and Kowatch 2006). Concerns have been raised about a possible association between divalproex and PCOS (Rasgon 2004). Other potential adverse effects of concern are hepatic failure, pancreatitis, thrombocytopenia, behavioral deterioration, and hair loss (Davanzo and McCracken 2000; Green 2001).

Side effects of topiramate include decreased appetite, weight loss, nausea, diarrhea, paresthesias, somnolence, and word-finding difficulties (DelBello and Kowatch 2006; DelBello et al. 2005).

Side effects of oxcarbazepine in children include dizziness, nausea, somnolence, diplopia, fatigue, and rash (Wagner et al. 2006b). Hyponatremia is also a side effect of oxcarbazepine.

Common side effects of lamotrigine in children include ataxia, nausea, vomiting, and constipation. Of particular concern, the incidence of serious rash, including Stevens-Johnson syndrome, in pediatric populations is reported to be 1%. This high incidence of serious rash may be attributable to the prior use of high dosages of lamotrigine with concomitant divalproex (Messenheimer 1998). The current dosing guidelines may reduce this rash incidence in pediatric patients.

Psychostimulants

Dosage and Monitoring

The American Academy of Child and Adolescent Psychiatry has developed practice parameters for the diagnosis and treatment of ADHD (Pliszka and AACAP Work Group on Quality Issues 2007). A wide variety of stimulant preparations are available; Table 55–4 describes their use in clinical practice. Each stimulant has a maximum dosage suggested by the FDA-approved package insert, but higher off-label dosages are commonly used with careful monitoring. For safety monitoring, a patient’s pulse, blood pressure, weight, and height should be obtained at baseline and at least annually. No laboratory measures or ECG monitoring is required.

TABLE 55–4. Clinical use of psychostimulants in children and adolescents

Medication	Dose strengths	Typical starting dosage	FDA max/day	Off-label max/day
Amphetamine preparations
Adderall	5, 7.5, 10, 12.5, 15, 20, 30 mg	3–5 yr: 2.5 mg qd	40 mg	≥50 kg: 60 mg
		≥6 yr: 5 mg qd–bid
Dexedrine	5 mg	3–5 yr: 2.5 mg qd	40 mg	≥50 kg: 60 mg
		≥6 yr: 5 mg qd–bid
Dextrostat	5, 10 mg	3–5 yr: 2.5 mg qd	40 mg	≥50 kg: 60 mg
		≥6 yr: 5 mg qd–bid
Dexedrine Spansule	5, 10, 15 mg	≥6 yr: 5–10 mg qd–bid	40 mg	≥50 kg: 60 mg
Adderall XR	5, 10, 15, 20, 25, 30 mg	≥6 yr: 10 mg qd	30 mg	≥50 kg: 60 mg
Vyvanse	30, 50, 70 mg	30 mg qd	70 mg	Not determined
Methylphenidate preparations
Focalin	2.5, 5, 10 mg	2.5 mg bid	20 mg	50 mg
Focalin XR	5, 10, 15, 20 mg	5 mg qam	30 mg	50 mg
Methylin	5, 10, 20 mg	5 mg bid	60 mg	≥50 kg: 100 mg
Metadate ER	10, 20 mg	10 mg qam	60 mg	≥50 kg: 100 mg
Methylin ER	10, 20 mg	10 mg qam	60 mg	≥50 kg: 100 mg
Ritalin SR	20 mg	10 mg qam	60 mg	≥50 kg: 100 mg
Metadate CD	10, 20, 30, 40, 50, 60 mg	20 mg qam	60 mg	≥50 kg: 100 mg
Ritalin LA	20, 30, 40 mg	20 mg qam	60 mg	Not yet known
Concerta	18, 27, 36, 54 mg	18 mg qam	72 mg	108 mg
Daytrana patch	10-, 15-, 20-, 30-mg patches	Begin with 10-mg patch qd; then titrate up by patch strength	30 mg	Not yet known
Quillivant XR	25 mg/5 mL	2 mL qam	12 mL	Not yet known
Aptensio XR	10, 15, 20, 30, 40, 50, 60 mg	10 mg qam	60 mg	Not yet known
Note. bid=twice daily; CD=controlled delivery (extended release); ER=extended release; FDA=U.S. Food and Drug Administration; LA=long acting (extended release); qam=every morning; qd=once daily; SR=sustained release; XR=extended release.

Side Effects

Common side effects of psychostimulants are insomnia, diminished appetite, weight loss, irritability, abdominal pain, and headaches (Pliszka and AACAP Work Group on Quality Issues 2007). Rebound symptoms of worsening behavior may occur when the effects of the short-acting psychostimulants dissipate. Switching to sustained-release or longer-acting psychostimulants may ameliorate rebound symptoms.

Although earlier reports of a protective effect from psychostimulants were not borne out by a later study (Molina et al. 2009), there is no evidence that psychostimulants increase substance abuse in youth with ADHD. Motor tics may develop during treatment with stimulants, but one study reported no increase in tics for children with or without preexisting tics who received typical clinical dosages of methylphenidate compared with placebo (Law and Schachar 1999).

The FDA and its Pediatric Advisory Committee have reviewed data regarding psychiatric adverse events related to stimulant medication (U.S. Food and Drug Administration 2006). Data from controlled trials and postmarketing safety data from sponsors and the FDA Adverse Events Reporting System (AERS), also referred to as MedWatch, were reviewed. For most of the agents, psychiatric adverse events were slightly more common in the groups given active drug rather than placebo in the controlled trials, but these differences did not reach statistical significance (Mosholder 2006). Postmarketing safety data were also reviewed for reports of mania/psychotic symptoms, aggression, and suicidality (Gelperin 2006). Rare events of suicidal thoughts, manic-like activation, or psychosis were reported. At the time, the Pediatric Advisory Committee did not recommend a black box warning regarding psychiatric adverse events but did suggest clarifying labeling regarding these phenomena. No changes to the stimulant medication labeling were suggested regarding suicide or suicidal ideation.

There have been rare reports of sudden death in patients taking stimulant medication. Villalaba (2006) reported that the FDA has records of 20 cases of sudden death with amphetamine or dextroamphetamine (14 children, 6 adults), and of 14 pediatric and 4 adult cases of sudden death with methylphenidate. It is important to note that the rate of sudden death in the general pediatric population has been estimated at 1.3–8.5 per 100,000 patient-years (Liberthson 1996). The rate of sudden death among individuals with a history of congenital heart disease can be as high as 6% by age 20 years (Liberthson 1996). Villalaba (2006) estimated the rate of sudden death in children treated for ADHD during the period encompassing January 1, 1992, to December 31, 2004, to be 0.2 per 100,000 patient-years for methylphenidate, 0.3 per 100,000 patient-years for amphetamine, and 0.5 per 100,000 patient-years for atomoxetine (the differences between the agents are not clinically meaningful). Because the rate of sudden death in children taking ADHD medications does not appear to exceed the base rate of sudden death in the general population, cardiac monitoring of healthy children during treatment with stimulants is not required. Children with preexisting heart disease (or significant symptoms suggesting the condition) should obtain a cardiology consultation prior to taking a stimulant.

Poulton (2005) reviewed growth data and concluded that stimulant treatment may be associated with a reduction in expected height gain, at least in the first 1–3 years of treatment. The National Institute of Mental Health (NIMH) Multimodal Treatment of ADHD (MTA) study showed reduced growth rates in patients with ADHD after 2 years of stimulant treatment compared with patients who received no medication (MTA Cooperative Group 2004), and these deficits persisted at 36 months (Swanson et al. 2007). The Preschool ADHD Treatment Study (PATS) followed a group of 140 preschoolers who received methylphenidate for ADHD for up to a year (Swanson et al. 2006). The subjects had less than expected mean gains in height (−1.38 cm) and weight (−1.3 kg). Charach et al. (2006) found that higher dosages of stimulants correlated with reduced gains in height and weight and that the effect did not become significant until the dosage in methylphenidate equivalents was >2.5 mg/kg/day for 4 years. Pliszka et al. (2006b) did not find that children with ADHD treated with monotherapy with either amphetamine or methylphenidate showed any failure to achieve expected height; furthermore, the two stimulant classes did not have a differential effect on height, although amphetamine had a somewhat greater effect on weight than did methylphenidate. The subjects in this study had drug holidays averaging 31% of the time during their treatment course, which may have contributed to the lack of effect of the stimulant on height.

In assessing for clinically significant growth reduction, it is recommended to use serial plotting of height and weight on growth charts labeled with lines showing the major percentiles (5th, 10th, 25th, 50th, 75th, 90th, and 95th) (Mei et al. 2004). This should occur one to two times per year and more frequently if practical. A change in height or weight that crosses two percentile lines suggests an aberrant growth trajectory. In these cases, a drug holiday should be considered if return of symptoms during weekends or summers does not lead to marked impairment of functioning. The clinician should also consider switching the patient to another ADHD medication. It is important for the clinician to carefully balance the benefits of medication treatment with the risks of small reductions in height gain, which as of yet have not been shown to be related to reductions in adult height (Klein and Mannuzza 1988; Kramer et al. 2000; Weiss and Hechtman 2003).