Lumateperone

CAPLYTA

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Pronunciation: loo-ma-TE-per-oen (kap-LITE-a)

Lumateperone ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Lumateperone ballicule

Lumateperone CAPLYTA mascot mnemonic cartoon — Visual mnemonic: Lumateperone mascot
**“’Luminated Cap lighter”**
Antipsychotics are represented with spooky mascots
42 mg starting dose = target dose

What it isD2 and 5-HT2A antagonist with serotonin reuptake inhibition; schizophrenia and bipolar depression.

Why this oneHas 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.

Lumateperone molecular structure (skeletal formula) — Molecular structure: Lumateperone

Lumateperone prescription history

Animated chart of estimated U.S. prescriptions per year, Antipsychotics (1954–2026). Lumateperone enters in 2020.

FDA-approved for

schizophrenia (2019)
bipolar depression (2021)

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability1 / 4

Sedation liability3 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis; suicidal thoughts and behaviors in pediatric/young adults. Not approved for dementia-related psychosis; not established in pediatrics.

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.

Available strengths

cap 10.5, 21, 42 mg

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%).

Cost

Lumateperone (CAPLYTA)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/mo	brand $/mo	CostPlus
10.5 mg	cap	30 qd	—	$1,717.29	not offered
21 mg	cap	30 qd	—	$1,716.01	not offered
42 mg	cap	30 qd	—	$1,717.41	not offered

Generic entry2040 est.

Serotonin and MAOI

Provisional washout figures

SRI significance2 / 4

MAO-A inhibition0 / 4

Serotonin release0 / 4

Elevating mechanismWeak/borderline SRI

Non-elevating actionPotent 5-HT2A antagonist

Exposure dependenceDose/exposure dependent; clinical relevance mainly with MAO-A inhibition

Washout BEFORE an MAOIU days

Evidence confidenceModerate

InterpretationMeaningful SERT binding/partial occupancy, counterbalanced by very potent 5-HT2A antagonism; clinical significance unresolved.

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Memory aids: interaction avatars

CYP3A4 substrate

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Self-check

What is lumateperone’s main tolerability problem?
Sedation.
Does lumateperone’s usual therapeutic-strength regimen require titration?
No.