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.
Drug Name | Available Dosage Strengths | Treatment Indication | Maximum Recommended Dosage |
---|---|---|---|
Aripiprazole (Abilify, Abilify MyCite system, generics) |
| Schizophrenia, BD |
|
MDD | 15 mg/day | ||
Asenapine (Saphris®, Secuado® Transdermal System, generics) |
| Schizophrenia, BD |
|
Brexpiprazole (Rexulti®) | 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tablets | Schizophrenia | 4 mg once daily |
MDD | 3 mg once daily | ||
Agitation associated with dementia due to Alzheimer’s disease | 3 mg once daily | ||
Cariprazine (Vraylar®) | 1.5 mg, 3 mg, 4.5 mg 6 mg capsules | Bipolar major depression, BD (acute mixed/manic episodes), schizophrenia | 6 mg once daily |
BD (acute mixed/manic episodes), schizophrenia | 6 mg once daily | ||
Clozapine (Clozaril, generics, Versacloz) |
| Schizophrenia (treatment-resistant), reducing recurrent suicidal behavior in schizophrenia and schizoaffective disorder (SD) |
|
Iloperidone (Fanapt®) | 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg 12 mg IR tablets | Schizophrenia | 24 mg/day, in divided doses |
Lumateperone (Caplyta®) | 10.5 mg, 21 mg, 42 mg capsules | Schizophrenia, bipolar depression | 42 mg/day |
Lurasidone (Latuda®) | 20 mg, 40 mg, 60 mg, 80 mg, 120 mg IR tablets | Schizophrenia | 160 mg/day, with food (at least 350 calories) |
Bipolar depression | 120 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 | Schizophrenia, BD, treatment-resistant depression | 5 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) tablets | Schizophrenia, SD | 12 mg/day |
Pimavanserin (Nuplazid®) | 10 mg tablets, 34 mg capsules | Hallucinations and delusions associated with Parkinson’s disease psychosis | 34 mg once daily |
Quetiapine (Seroquel®, Seroquel XR®, generics) |
| Schizophrenia, BD (acute manic episodes, maintenance) |
|
Schizophrenia | 750 mg/day, in two or three divided doses | ||
Bipolar depression |
| ||
Quetiapine (Seroquel XR®, generics) | MDD | ER: 300 mg/day, as a single dose | |
Risperidone (Risperdal®, Risperdal M-TAB®, generics) |
| Schizophrenia | 8 mg/day in 1 or 2 divided doses * |
Bipolar mania | 6 mg/day | ||
Ziprasidone (Geodon®, generics) | 20 mg, 40 mg, 60 mg, 80 mg IR capsules | Schizophrenia | 200 mg/day, in two divided doses + |
BD | 160 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.
Drug Name | Available Dosage Strengths | Treatment Indication | Maximum Recommended Dosage |
---|---|---|---|
Olanzapine/ fluoxetine (Symbyax, generics ) |
| Bipolar depression, treatment-resistant depression | Olanzapine 18 mg/ fluoxetine 75 mg once daily in evening, without regard to meals |
Olanzapine/ samidorphan (Lybalvi®) |
| Schizophrenia, BD | Olanzapine 20 mg/ samidorphan 10 mg once daily |