What is Vilazodone (Vortioxetine)?

From the Guidelines

Vilazodone is a recommended treatment option for major depressive disorder (MDD) in adult outpatients, particularly for those who do not respond to initial treatment with selective serotonin reuptake inhibitors (SSRIs) 1. When considering vilazodone, it's essential to note that the American College of Physicians guideline recommends it as one of the serotonin-norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) for the treatment of MDD in adult outpatients 1. The guideline evaluates the quality of evidence using the AHRQ handbook and assesses the risk of bias using AHRQ guidance and the Cochrane Risk of Bias tool 1. Some key points to consider when prescribing vilazodone include:

• Starting dose: 10 mg once daily for 7 days, then increased to 20 mg once daily for another 7 days, with a target dose of 40 mg once daily
• Administration: should be taken with food to enhance absorption and effectiveness
• Mechanism of action: works as both an SSRI and a partial agonist of serotonin 5-HT1A receptors
• Common side effects: diarrhea, nausea, vomiting, and insomnia, which often improve over time
• Sexual side effects: may be less common compared to other SSRIs
• Antidepressant effects: may take 2-4 weeks to develop
• Tapering: should not be stopped abruptly but tapered under medical supervision
• Black box warning: increased suicide risk in young adults and adolescents, particularly during the first few weeks of treatment 1.

From the FDA Drug Label

5 Geriatric Use Based on a pharmacokinetic study, no dosage adjustment of vilazodone hydrochloride is recommended on the basis of age In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy 8. 6 Use in Other Patient Populations No dosage adjustment of vilazodone hydrochloride is necessary on the basis of gender, renal function (mild to severe renal impairment, glomerular filtration rate: 15 to 90 mL/minute), or hepatic function (mild to severe hepatic impairment, Child-Pugh score: 5 to 15

Key Points:

• No dosage adjustment of vilazodone is recommended based on age.
• Dose selection for elderly patients should be conservative, starting at the low end of the dosing range.
• No dosage adjustment is necessary based on gender, renal function, or hepatic function. 2

From the Research

Vilazodone Overview

• Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A partial agonist approved for major depressive disorder (MDD) treatment in adults 3, 4, 5, 6, 7.
• It is administered orally, once daily, with food, and the recommended dosage is 40 mg/day 5, 6.

Efficacy

• Vilazodone has been shown to be effective in the treatment of MDD, with significant improvements in depressive symptoms compared to placebo 3, 4, 5, 6, 7.
• The efficacy of vilazodone has been demonstrated across a range of symptoms and severities of depression, with significant improvement on all 10 individual MADRS symptom items at end of treatment 7.
• Vilazodone treatment has been associated with significant reductions in MADRS total score, with improvements seen as early as week 1 and continuing throughout treatment 3, 4, 7.

Safety and Tolerability

• Vilazodone is generally well tolerated, with the most common adverse events being diarrhea, nausea, vomiting, and insomnia 3, 4, 5, 6.
• Vilazodone has been shown to have a minimal impact on sexual functioning, with no significant differences in sexual function compared to placebo 3, 5.
• The most common treatment-emergent adverse events were mild or moderate diarrhea, nausea, and headache 4.

Clinical Trials

• Vilazodone has been studied in several clinical trials, including four randomized, double-blind, placebo-controlled trials, which demonstrated its efficacy and safety in the treatment of MDD 3, 4, 5, 7.
• A noncomparative study showed that MADRS total scores continued to improve throughout therapy for up to 1 year 4.
• A 52-week, noncomparative, phase III study demonstrated the long-term efficacy and safety of vilazodone in the treatment of MDD 5.