1.1. Adults

Oral atypical antipsychotics are FDA-approved for use in schizophrenia, bipolar I disorder (BD), bipolar disorder with mixed episodes or depressive episodes, bipolar mania, schizoaffective disorder (SD), adjunctive therapy in major depressive disorder (MDD), treatment-resistant schizophrenia, and irritability associated with autism.1-14 Cariprazine (Vraylar) is approved to treat schizophrenia and manic or mixed episodes associated with BD.1,15  Aripiprazole tablets with sensors (Abilify MyCite) are approved to track medication com pliance1,16.

Pimavanserin (Nuplazid) is an oral atypical antipsychotic that is indicated for use to manage hallucinations and delusions seen with Parkinson’s disease psychosis1,17. Olanzapine combination therapy is FDA-approved for use in managing treatment-resistant depression as well as acute depressive episodes associated with bipolar I disorder1,18. Secuado (asenapine) Transdermal System is a topical patch that is FDA approved for the management of schizophrenia in adult patients.1, 19 Additionally, Caplyta (lumateperone) is a once daily oral capsule that is FDA approved for the management of schizophrenia in adult patients1,20.

Maximum recommended adult doses for atypical antipsychotics are summarized in Table 1. Dosages exceeding these recommendations will be reviewed.

Table 1. Oral Atypical Antipsychotics (Monotherapy) - Adult Maximum Recommended Dosages1-17,19,20
Drug NameAvailable Dosage StrengthsTreatment IndicationMaximum Recommended Dosage
Aripiprazole (Abilify, Abilify MyCite system, generics)
  • 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg immediate-release (IR) tablets
  • 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg IR tablets with sensor#
  • 10 mg, 15 mg orally disintegrating tablets (ODTs)
  • 1 mg/ml oral solution
Schizophrenia, BD
  • oral tablets & oral solution : 30 mg/day
  • oral solution: 25 mg/day
  MDD15 mg/day
Asenapine (Saphris®, Secuado® Transdermal System, generics)
  • 2.5 mg, 5 mg, 10 mg sublingual tablets
  • 3.8 mg/24 hr, 5.7 mg/24 hr, 7.6 mg/24 hr transdermal patch
Schizophrenia, BD
  • 20 mg/day, in two divided doses
  • 7.6 mg/24 hr transdermally
Brexpiprazole (Rexulti®)0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tabletsSchizophrenia4 mg once daily
  MDD3 mg once daily
  Agitation associated with dementia due to Alzheimer’s disease3 mg once daily
Cariprazine (Vraylar®)1.5 mg, 3 mg, 4.5 mg 6 mg capsulesBipolar major depression, BD (acute mixed/manic episodes), schizophrenia6 mg once daily 
  BD (acute mixed/manic episodes), schizophrenia6 mg once daily
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
Schizophrenia (treatment-resistant), reducing recurrent suicidal behavior in schizophrenia and schizoaffective disorder (SD)
  • 900 mg/day, in divided doses
Iloperidone (Fanapt®)1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg 12 mg IR tabletsSchizophrenia24 mg/day, in divided doses
Lumateperone (Caplyta®)10.5 mg, 21 mg,  42 mg capsulesSchizophrenia, bipolar depression42 mg/day
Lurasidone (Latuda®)20 mg, 40 mg, 60 mg, 80 mg, 120 mg IR tabletsSchizophrenia160 mg/day, with food (at least 350 calories)
  Bipolar depression120 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 tabletsSchizophrenia, BD, treatment-resistant depression5 mg, 10 mg, 15 mg, 20 mg ODTs    20 mg/day, as a single dose
Paliperidone (Invega®)1.5 mg, 3 mg, 6 mg, 9 mg extended-release (ER) tabletsSchizophrenia, SD12 mg/day
Pimavanserin (Nuplazid®)10 mg tablets, 34 mg capsulesHallucinations and delusions associated with Parkinson’s disease psychosis34 mg once daily
Quetiapine (Seroquel®, Seroquel XR®, generics)
  • 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
Schizophrenia, BD (acute manic episodes, maintenance)
  • IR: 800 mg/day, in two or three divided doses
  • ER: 800 mg/day, as a single dose
  Schizophrenia750 mg/day, in two or three divided doses 
  Bipolar depression
  • IR: 300 mg/day, at bedtime
  • ER: 300 mg/day, as a single dose
Quetiapine (Seroquel XR®, generics) MDDER: 300 mg/day, as a single dose
Risperidone (Risperdal®, Risperdal M-TAB®, 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
Schizophrenia8 mg/day in 1 or 2 divided doses *
  Bipolar mania6 mg/day
Ziprasidone (Geodon®, generics)20 mg, 40 mg, 60 mg, 80 mg IR capsulesSchizophrenia200 mg/day, in two divided doses +
  BD160 mg/day, in two divided doses

Legend:

  • # ingestible event marker (IEM) embedded in each MyCite® tablet; to be dispensed with MyCite® patch (wearable sensor that detects signal frim IEM sensor) and MyCite App
  • * doses up to 16 mg/day have demonstrated efficacy in clinical trials; however, doses of 4 to 8 mg/day tended to produce the maximal effect    
  • + doses up to 320 mg daily have been used safely but greater efficacy not noted with higher dosages

Lybalvi is an oral combination product containing olanzapine and samidorphan that is FDA approved for the management of acute mixed or manic episodes in bipolar 1 disorder, maintenance therapy in bipolar 1 disorder, and for the management of schizophrenia1,21. Samidorphan that binds to mu, kappa, and delta opioid receptors. Samidorphan is a mu-opioid receptor antagonist, and it demonstrates partial agonist activity on kappa, and delta-opioid receptors. The major metabolites of samidorphan also have an affinity for opioid receptors, however, neither metabolite is thought to contribute to the pharmacologic effects of the drug1, 21. Doses exceeding the maximum adult recommended doses summarized in Table 2 will be reviewed.

Table 2. Oral Atypical Antipsychotics (Combination Therapy) – Adult Maximum Recommended Dosages1,18,21
Drug NameAvailable Dosage StrengthsTreatment IndicationMaximum Recommended Dosage
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
Bipolar depression, treatment-resistant depressionOlanzapine 18 mg/ fluoxetine 75 mg once daily in evening, without regard to meals
Olanzapine/ samidorphan (Lybalvi®)
  • Olanzapine 5 mg/ samidorphan 10 mg
  • olanzapine 10 mg/ samidorphan 10 mg
  • olanzapine 15 mg/ samidorphan 10 mg
  • olanzapine 20 mg, samidorphan 10 mg
Schizophrenia, BDOlanzapine 20 mg/ samidorphan 10 mg once daily