Lumateperone
CAPLYTA
What it isD2 and 5-HT2A antagonist with serotonin reuptake inhibition; schizophrenia and bipolar depression.
Why this oneIt has very little metabolic or extrapyramidal burden and comes at a single therapeutic strength without titration.
What limits itSedation is the main tolerability problem. CYP3A4 interactions can make the fixed regimen unusable.
FDA-approved for
- schizophrenia (2019)
- bipolar depression (2021)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Schizophrenia | Adults | 42 mg QD | 42 mg QD | 42 mg QD |
| Bipolar depression (I or II; monotherapy or adjunct to lithium/valproate) | Adults | 42 mg QD | 42 mg QD | 42 mg QD |
| Major depressive disorder (adjunct to antidepressants) | Adults | 42 mg QD | 42 mg QD | 42 mg QD |
Renal Undefined
Hepatic Moderate or severe (Child-Pugh B/C): 21 mg QD. Mild (A): no adjustment.
Instructions
- Take with or without food.
- No dose titration needed.
Cautions
- Cerebrovascular reactions (stroke, TIA) in elderly with dementia
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
- Leukopenia, neutropenia, agranulocytosis
- Orthostatic hypotension and syncope
- Falls
- Seizures
- Cognitive/motor impairment
- Body temperature dysregulation
- Dysphagia
Adverse reactions
- Somnolence/sedation
- Dry mouth
- Dizziness
- Nausea
- Fatigue
- Diarrhea
- Headache
Pregnancy Human data insufficient; third-trimester exposure risks neonatal EPS/withdrawal.
Lactation Present in human milk in low amounts (RID ~0.06%).
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Cost, est. cash$300–$2,500/month
Generic entry2040 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.
Mechanism of action: Lumateperone ballicule
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Memory aids: mascots and interaction avatars
Antipsychotics are represented with spooky mascots
42 mg starting dose = target dose
