Caplyta (Lumateperone) Dosing
The recommended dosage of Caplyta is 42 mg administered orally once daily, with or without food, and no dose titration is required. 1
Standard Dosing
- Adults with schizophrenia: 42 mg once daily 1
- Administration can be with or without food 1
- No titration necessary—patients start at the therapeutic dose 1
Dose Adjustments for Drug Interactions
When Caplyta is coadministered with CYP3A4 inhibitors, dose reduction is mandatory due to increased lumateperone exposure:
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): Reduce dose to 10.5 mg once daily 1
- Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin): Reduce dose to 21 mg once daily 1
Dose Adjustments for Hepatic Impairment
- Moderate hepatic impairment (Child-Pugh B): 21 mg once daily 1
- Severe hepatic impairment (Child-Pugh C): 21 mg once daily 1
- No adjustment needed for mild hepatic impairment 1
Clinical Context
Lumateperone represents a mechanistically novel antipsychotic that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission 2. The fixed 42 mg dose demonstrated significant efficacy in reducing PANSS total scores in clinical trials while maintaining a favorable tolerability profile with low rates of extrapyramidal symptoms (1.0%) and metabolic adverse effects 3. The most common treatment-emergent adverse events at the standard dose include somnolence (6.6%), headache (5.3%), and dry mouth (5.3%), with most being mild to moderate in severity 3.
Important caveat: Unlike many antipsychotics that require gradual titration, Caplyta's lack of titration requirement simplifies initiation but means patients experience the full therapeutic dose—and any associated sedation—from day one 1.