What is the recommended dose for lurasidone (atypical antipsychotic)?

Recommended Dose for Lurasidone

For bipolar depression in adults, start lurasidone at 20 mg once daily with food (at least 350 calories), with an effective dose range of 20-120 mg/day and a maximum dose of 120 mg/day. 1

Standard Dosing by Indication

Bipolar Depression (FDA-Approved)

Adults:

• Starting dose: 20 mg once daily 1
• Effective range: 20-120 mg/day 1
• Maximum dose: 120 mg/day 1
• No initial titration required 1
• Clinical trials showed the higher dose range (80-120 mg/day) did not provide additional efficacy compared to lower doses (20-60 mg/day) 1

Pediatric patients (10-17 years):

• Starting dose: 20 mg once daily 1
• Effective range: 20-80 mg/day 1
• Maximum dose: 80 mg/day 1
• May increase after one week based on clinical response 1
• Most patients (67%) in clinical trials received 20-40 mg/day 1

Schizophrenia (Referenced in Research)

• Starting dose: 40 mg/day 2, 3, 4
• Recommended range: 40-80 mg/day 2, 3
• Extended range: Up to 160 mg/day has been studied 5, 2
• Doses above 80 mg/day may not confer additional benefit and can increase adverse effects like somnolence and akathisia 2, 3

Critical Administration Requirements

Must be taken with food containing at least 350 calories 1

• Administration with food increases AUC approximately 2-fold and Cmax approximately 3-fold 1
• This is not optional—absorption is substantially reduced without food 1

Dose Modifications for Special Populations

Renal Impairment

• Moderate impairment (CrCl 30-50 mL/min): Start at 20 mg/day, maximum 80 mg/day 1
• Severe impairment (CrCl <30 mL/min): Start at 20 mg/day, maximum 80 mg/day 1

Hepatic Impairment

• Moderate impairment (Child-Pugh 7-9): Start at 20 mg/day, maximum 80 mg/day 1
• Severe impairment (Child-Pugh 10-15): Start at 20 mg/day, maximum 40 mg/day 1

Drug Interactions

With moderate CYP3A4 inhibitors (diltiazem, erythromycin, fluconazole, verapamil):

• If adding inhibitor to existing lurasidone: Reduce lurasidone dose to half 1
• If adding lurasidone to existing inhibitor: Start at 20 mg/day, maximum 80 mg/day 1

Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) are contraindicated 1

Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's wort) are contraindicated 1

Grapefruit and grapefruit juice must be avoided as they inhibit CYP3A4 1

Key Safety Considerations

• Metabolic profile: Lurasidone is associated with minimal weight gain and no clinically meaningful alterations in glucose, lipids, or QTc interval 5, 2, 3, 4
• Common adverse effects: Somnolence, akathisia, nausea, and parkinsonism, particularly early in treatment 5, 4
• Long-term use: Effectiveness beyond 6 weeks has not been established in controlled studies; periodically re-evaluate continued use 1

Clinical Decision Algorithm

1. Confirm indication: Bipolar depression (approved) vs. schizophrenia (different dosing) 1
2. Assess organ function: Check renal and hepatic function to determine if dose adjustment needed 1
3. Review medications: Screen for CYP3A4 inhibitors/inducers and adjust accordingly 1
4. Start at 20 mg once daily with food (≥350 calories) for bipolar depression 1
5. Titrate based on response: Can increase dose, but recognize that higher doses may not provide additional benefit in bipolar depression 1
6. Monitor for akathisia and somnolence, especially in first few weeks 5, 4