Lurasidone (Latuda) Dosing for Bipolar Disorder Monotherapy
For adults with bipolar I depression, 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
Adult Dosing Protocol
Starting Dose and Titration
- Begin with 20 mg once daily as monotherapy 1
- No initial dose titration is required 1
- The effective dose range is 20-120 mg per day 1
- Maximum recommended dose is 120 mg per day 1
Critical Administration Requirement
- Must be taken with food containing at least 350 calories 1
- Administration with food increases absorption approximately 2-fold (AUC) and 3-fold (Cmax) 1
- This is not optional—food substantially increases bioavailability and all clinical trials administered lurasidone with food 1
Dose Selection Considerations
- In monotherapy studies, the higher dose range (80-120 mg/day) did not provide additional efficacy compared to the lower dose range (20-60 mg/day) 1
- Most patients respond adequately to doses in the 20-60 mg/day range 1
- Consider starting at 20 mg and maintaining this dose if effective before escalating 2, 3
Pediatric Dosing (Ages 10-17 Years)
Starting Dose and Titration
- Start with 20 mg once daily as monotherapy 1
- No initial titration required 1
- May increase dose after one week based on clinical response 1
- Effective dose range is 20-80 mg per day 1
- Maximum recommended dose is 80 mg per day 1
- In clinical studies, 67% of pediatric patients received 20 mg or 40 mg once daily at study endpoint 1
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
Important Clinical Considerations
Indication Specificity
- Lurasidone is NOT approved for treatment of mania associated with bipolar disorder 1
- It is specifically indicated only for bipolar I depression as monotherapy or adjunctive therapy 1
- The American Academy of Child and Adolescent Psychiatry recommends lurasidone as monotherapy at flexible doses of 20-80 mg/day, with 6-week trial duration before concluding ineffectiveness 4
Duration of Treatment
- Effectiveness for longer-term use beyond 6 weeks has not been established in controlled studies 1
- Periodically re-evaluate long-term usefulness for individual patients 1
- Long-term data up to 2 years shows lurasidone is safe and well-tolerated with minimal effects on weight and metabolic parameters 5
Safety Profile
- Most commonly observed adverse reactions (≥5% and at least twice placebo rate) are akathisia, extrapyramidal symptoms, and somnolence 3
- Minimal weight gain and no clinically meaningful alterations in glucose, lipids, or ECG QTc interval 6
- Mean weight change over 18 months of continuation treatment was +0.8 kg 5
- Lurasidone and ziprasidone are the most weight-neutral atypical antipsychotics 7
Common Pitfalls to Avoid
Administration Errors
- Never prescribe lurasidone without explicit instructions to take with food (≥350 calories) 1
- Failure to take with food results in substantially reduced absorption and therapeutic failure 1
Inappropriate Use
- Do not use lurasidone for acute mania or mixed episodes—it is not indicated and has not been studied for these presentations 1
- Avoid using lurasidone as monotherapy when antidepressant monotherapy principles apply—always ensure mood stabilization 4