What is the recommended dosing for Latuda (lurasidone)?

Latuda (Lurasidone) Dosing

Bipolar I Depression

For adults with bipolar depression, start lurasidone at 20 mg once daily (either as monotherapy or adjunctive to lithium/valproate), with an effective dose range of 20-120 mg/day and a maximum dose of 120 mg/day. 1

Adult Dosing Specifics

• Starting dose: 20 mg once daily 1
• No initial titration required 1
• Effective range: 20-120 mg/day as monotherapy or adjunctive therapy 1, 2
• Maximum dose: 120 mg/day 1
• Important caveat: In monotherapy studies, higher doses (80-120 mg/day) did not provide additional efficacy compared to lower doses (20-60 mg/day) 1

Pediatric Dosing (Ages 10-17 Years)

• Starting dose: 20 mg once daily as monotherapy 1
• Titration: May increase after one week based on clinical response 1
• Effective range: 20-80 mg/day 1
• Maximum dose: 80 mg/day 1
• Clinical note: In trials, 67% of patients received 20-40 mg once daily at study end 1

Schizophrenia (Adults)

For schizophrenia, the recommended starting dose is 40 mg once daily with a dose range of 40-160 mg/day, though the FDA-approved maximum is 80 mg/day. 1, 3

• Starting dose: 40 mg/day 1, 4, 5
• No initial titration required 1, 4
• FDA-approved range: 40-80 mg/day 1, 4
• Extended range: Studies support efficacy up to 160 mg/day 3, 6
• Efficacy consideration: Meta-analysis shows 80-160 mg doses demonstrate significant improvement in PANSS scores, while 40 mg may not differ significantly from placebo 6

Critical Administration Requirements

Lurasidone must be taken with food (at least 350 calories) as this increases absorption approximately 2-fold for AUC and 3-fold for Cmax. 1, 5

Dose Modifications for Special Populations

Renal Impairment

• Moderate impairment (CrCl 30 to <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

• Strong CYP3A4 inhibitors: Contraindicated (e.g., ketoconazole, clarithromycin, ritonavir) 1
• Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole): Reduce lurasidone dose to half of original level; if starting lurasidone, begin at 20 mg/day with maximum of 80 mg/day 1

Safety Profile

Common adverse effects include somnolence, akathisia, nausea, and parkinsonism, particularly early in treatment, but lurasidone demonstrates minimal weight gain and no clinically meaningful alterations in glucose, lipids, or QTc interval. 3, 4, 5

• Most common adverse events: Somnolence, akathisia, nausea, extrapyramidal symptoms 3, 4, 6
• Dose-dependent effects: Higher doses (120-160 mg) associated with increased akathisia, nausea, and somnolence 6
• Metabolic advantages: Minimal weight gain, no significant glucose or lipid alterations 3, 4, 5, 2
• Cardiovascular: No orthostatic hypotension or QTc prolongation 4, 2

Duration of Treatment

Effectiveness beyond 6 weeks has not been established in controlled studies; physicians should periodically re-evaluate long-term usefulness for individual patients. 1