1.2. Pediatrics

Risperidone is FDA-approved to manage symptoms of irritability in autistic children greater than 5 years of age and adolescents, and is approved for bipolar mania in children and adolescents 10 to 17 years of age and schizophrenia in adolescents 13 to 17 years of age1,6. Aripiprazole is FDA approved for treating Tourette’s disorder in pediatric patients 6 to 18 years of age, and is also FDA-approved for managing schizophrenia in adolescents 13 to 17 years of age, bipolar disorder with or without psychotic features in children 10 to 17 years of age, and irritability associated with autistic disorder in children 6 to 17 years of age1,9. Olanzapine is FDA approved for bipolar disorder and schizophrenia in adolescents 13 years of age and older.1,10 Olanzapine is also FDA approved to treat depressive episodes associated with bipolar 1 disorder in patients 10 years of age and older when used in combination with fluoxetine1,18. Quetiapine is FDA approved for acute treatment of bipolar disorder mania episodes in children and adolescents 10 to 17 years of age and schizophrenia management in adolescents 13 to 17 years of age1,11,12. Paliperidone is approved FDA for the management of schizophrenia in adolescents 12 to 17 years of age1,8. Lurasidone is approved for the management of depressed phase bipolar disorder in children 10 to 17 years of age, and it is approved for the management of schizophrenia in patients 13 to 17 years of age1,13. Cariprazine, clozapine, iloperidone, lumateperone, ziprasidone, and aripiprazole tablets with sensors (Abilify MyCite) are not recommended for use in pediatric patients as safety and efficacy have not been established in this patient population. Additionally, pimavanserin is not approved for use in pediatric patients as Parkinson’s disease is typically not observed in pediatric patients, and safety and efficacy data are not available for pimavanserin in the pediatric population1-3,5,7,15-17,20.

Atypical antipsychotic pediatric dosages are summarized in Table 3. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Tables 3 and 422.

Table 3. Atypical Antipsychotics (Monotherapy) – Pediatric Maximum Recommended Dosages1-6,8-14
Drug NameAvailable Dosage StrengthsTreatment IndicationLiterature Based Maximum DosageFDA Approved Maximum Recommended Dosage 
Aripiprazole (Abilify,generics)
  • 2 mg, 5 mg, 10mg, 15 mg, 20 mg, 30 mg immediate-release (IR) tablets
  • 10 mg, 15 mg orally disintegrating tablets (ODTs)
  • 1 mg/ml oral solution
Schizophrenia
  • Age 4-11 years: 15 mg/day
  • Age greater than or equal to 12 years: 30 mg/day
13-17 years of age: 30 mg once daily
  BD 10-17 years of age: 30 mg once daily
  Tourette’s disorder 

6-18 years of age:

  • Less than 50 kg: 10 mg/day
  • Greater than or equal to 50 kg: 20 mg/day
  Irritability associated with autism 6-17 years of age: 15 mg/day as a single dose
Asenapine (Saphris®)2.5 mg, 5 mg, 10 mg sublingual tabletsBDAge greater than or equal to 10 years: 10 mg twice daily10-17 years of age: 20 mg/day, in two divided doses
Brexpiprazole (Rexulti)0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tabletsSchizophrenia Age 13-17 years: 4 mg/ day
Clozapine (Clozaril, generics, Versacloz)
  • 25 mg, 50 mg, 100 mg, 200 mg IR tablets
  • 12.5 mg, 25 mg, 100 mg, 150 mg, 200 mg ODTs
  • 50 mg/ml oral suspension
Reserved for treatment resistant psychosis, following two failed trials of antipsychotic therapy with adequate dose/ duration
  • Age 8-11 years: 150- 300 mg/day
  • Age greater than or equal to 12 years: 600 mg/day
  • Target serum clozapine level of 350 ng/mL for optimal efficacy
Not approved for children or adolescents 
Lurasidone (Latuda®)20 mg, 40 mg, 60 mg, 80 mg IR tabletsSchizophrenia, BD
  • Schizophrenia (age 13-17 years): 80 mg/day
  • Bipolar I Depression (age 10-17 years): 80 mg/day
13 to 17 years of age: 80 mg/day, with food (at least 350 calories)
Olanzapine (Zyprexa®, Zyprexa Zydis®, generics)
  • 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg IR tablets
  • 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tablets
Schizophrenia, BD
  • Age 4-5 years: 12.5 mg/day
  • Age 6-17 years: 20 mg/ day
13 to 17 years of age: 20 mg once daily
Paliperidone (Invega®)1.5 mg, 3 mg, 6 mg, 9 mg extended-release (ER) tabletsSchizophrenia

Adolescents (age greater than or equal to 12 years), schizophrenia: 

  • Weight less than 51 kg: 6 mg/day
  • Weight greater than or equal to 51 kg: 12 mg/day

12-17 years of age:

  • Less than 51 kg: 6 mg/day
  • Greater than or equal to 51 kg: 12 mg/day
Quetiapine (Seroquel, generics, Seroquel XR)
  • 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg IR tablets
  • 50 mg, 150 mg, 200 mg, 300 mg, 400 mg ER tablets
BD - acute manic episodes
  • Age 5- 9 years: 400 mg/day
  • Age 10-17 years: 800 mg/day
10 to 17 years of age: 600 mg daily, once daily (ER tablets) or in 2 to 3 divided doses (IR tablets)
  Schizophrenia 13 to 17 years of age: 800 mg daily, once daily (ER tablets) or in 2 to 3 divided doses (IR tablets)
Risperidone (Risperdal, generics)
  • 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg IR tablets
  • 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg ODTs
  • 1 mg/ml oral solution
Bipolar mania
  • Age 4-11 years: 3 mg/day
  • Age greater than or equal to12 years:6 mg/day
10-17 years of age: 6 mg daily
  Schizophrenia 13-17 years of age: 6 mg daily
  Irritability in autistic disorder 5-17 years of age: 3 mg/day (no dosing data available for pediatric patients less than 15 kg)
Ziprasidone (Geodon, generics)20 mg, 40 mg, 60 mg, 80 mg IR capsulesBP

Bipolar Disorder (age10-17 years)

  • Weight less than or equal to 45 kg: 80 mg/day
  • Weight greater than 45 kg
Not approved for children or adolescents

The olanzapine/fluoxetine combination has been approved for use in pediatric patients 10-17 years of age with depression associated with BD1,18. Recommended pediatric dosages are summarized in Table 4.

Table 4. Oral Atypical Antipsychotics (Combination Therapy) – Pediatric Maximum Recommended Dosages1,18
Drug NameAvailable Dosage StrengthsLiterature Based Maximum DosageTreatment IndicationMaximum Recommended Dosage per Age Group
Olanzapine/ fluoxetine (Symbyax, generics)
  • Olanzapine 3 mg/fluoxetine 25 mg
  • olanzapine 6 mg/fluoxetine 25 mg
  • olanzapine 6 mg/fluoxetine 50 mg
  • olanzapine 12 mg/fluoxetine 25 mg
  • olanzapine 12 mg/fluoxetine 50 mg
Age 10-17 years: 12 mg olanzapine/50 mg fluoxetine once dailyBipolar depression10-17 years of age:  olanzapine 12 mg/ fluoxetine 50 mg once daily in evening, without regard to meals