Atypical Antipsychotic — Multimodal (Schizophrenia / Bipolar Depression) Pregnancy: Available data from case reports in pregnant women are insufficient to establish drug-associated risks for birth defects, miscarriage or adverse maternal/fetal outcomes. Neonates exposed to antipsychotic drugs during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms following delivery. A pregnancy exposure registry for atypical antipsychotics is available (US label section 8.1).

Lumateperone

Brand names: Caplyta

Lumateperone is an atypical (second-generation) antipsychotic used in the treatment of schizophrenia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 42 mg once daily

Route: Oral (capsules)

Frequency: Once daily, with or without food

Max: 42 mg daily (the label refers to 42 mg/day as the maximum recommended human dose); lower maxima apply with CYP3A4 inhibitors and in hepatic impairment

US label (CAPLYTA, Intra-Cellular Therapies, label date 2025-06-20): 'The recommended CAPLYTA dosage is 42 mg administered orally once daily with or without food. Dose titration is not needed.' Dose reductions stated in the label: strong CYP3A4 inhibitors 10.5 mg once daily; moderate CYP3A4 inhibitors 21 mg once daily; moderate or severe hepatic impairment (Child-Pugh class B or C) 21 mg once daily (mild hepatic impairment: same dosage as normal hepatic function). Available capsule strengths 42 mg, 21 mg, 10.5 mg. Paediatrics: 'Safety and effectiveness of CAPLYTA have not been established in pediatric patients.' No UK SPC (eMC) was present in this bundle, so the whole record is from US labelling and must be checked against the UK SPC before publication. No renal adjustment was stated in the sections fetched. Several fetched sections (geriatric, pregnancy, warnings, interactions, adverse) were truncated at the source-fetch limit, so the lists below are not necessarily complete.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity to lumateperone or any component of the product (reported reactions have included pruritus, rash — allergic dermatitis, papular rash, generalised rash — and urticaria)

Side effects

Somnolence/sedation
Dry mouth
Dizziness
Nausea
Fatigue

Interactions

CYP3A4 inducers — avoid concomitant use (they decrease lumateperone exposure)
Strong CYP3A4 inhibitors — reduce dosage to 10.5 mg once daily
Moderate CYP3A4 inhibitors — reduce dosage to 21 mg once daily
Serotonin reuptake inhibitors (SSRI/SNRI) — increased monitoring for SRI-associated adverse reactions is recommended

Clinical monograph

How it works

It modulates serotonergic, dopaminergic and glutamatergic neurotransmission, acting as a serotonin 5-HT2A receptor antagonist and a dopamine D2 receptor modulator with presynaptic partial agonist and postsynaptic antagonist activity.

Prescribing in practice

As with all antipsychotics, there is an increased risk of stroke and death when used in elderly patients with dementia-related psychosis, and it is not licensed for this indication.
Antipsychotics can prolong the QT interval, so caution is advised in patients with cardiac risk factors or those taking other QT-prolonging medicines.
Exposure is altered by CYP3A4 inhibitors and inducers, so review concomitant interacting medicines.

Monitoring

Monitor metabolic parameters including weight, blood glucose and lipids, alongside cardiovascular status, in line with antipsychotic monitoring standards.

Counselling the patient

May cause drowsiness; take care with driving or operating machinery until you know how it affects you.
Report any abnormal movements, persistent fever, or muscle stiffness promptly.
Do not stop the medicine suddenly without discussing it with your prescriber.

Evidence & guidelines

Lumateperone's efficacy in schizophrenia is supported by randomised placebo-controlled trials, and its use should follow the approved product information.

Reference: Davis et al. JAMA Psychiatry 2019 (schizophrenia trial); Calabrese et al. NEJM 2021 (bipolar depression); MHRA SPC Caplyta; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways