What is the therapeutic dose of Lurasidone (atypical antipsychotic) for adults?

Lurasidone Therapeutic Dose for Adults

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

FDA-Approved Dosing for Bipolar Depression

• Starting dose: 20 mg once daily, taken with food (at least 350 calories) 1
• Effective dose range: 20-120 mg/day as monotherapy or adjunctive therapy with lithium or valproate 1
• Maximum dose: 120 mg/day 1
• No initial titration required - patients can remain at the starting dose or increase based on clinical response 1

Critical Administration Requirement

• Must be taken with food containing at least 350 calories - this increases absorption approximately 2-fold (AUC) and 3-fold (Cmax) compared to fasting administration 1
• All clinical trials demonstrating efficacy were conducted with food administration 1

Dose Adjustments 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

Evidence for Dose Selection in Bipolar Depression

• In monotherapy studies, the higher dose range (80-120 mg/day) did not provide additional efficacy on average compared to the lower dose range (20-60 mg/day) 1
• This suggests that many patients will respond adequately to doses in the 20-60 mg/day range without requiring maximum dosing 1

Schizophrenia Dosing (Off-Label Context)

While lurasidone is FDA-approved for schizophrenia, the question specifically asks about therapeutic dosing for adults:

• Recommended starting dose: 40 mg/day with food 2, 3
• Effective dose range: 40-160 mg/day 2
• No initial titration required 2
• Meta-analysis data suggest 80 mg as an optimal initial dose for schizophrenia, with increases to 160 mg for more severe cases 4

Duration of Adequate Trial

• Minimum trial duration: 4-6 weeks at therapeutic doses before determining treatment failure 5, 6
• Antipsychotic effects typically become apparent after 1-2 weeks 6
• For long-term maintenance in bipolar depression, effectiveness beyond 6 weeks has not been established in controlled studies, requiring periodic re-evaluation 1

Common Adverse Effects to Monitor

• Most common: Somnolence, akathisia, nausea, and parkinsonism 2, 3
• Metabolic profile: Minimal weight gain and no clinically meaningful alterations in glucose, lipids, or QTc interval 2, 3
• Risk of akathisia, nausea, somnolence, and extrapyramidal symptoms increases at doses of 80-120 mg 4