Vilazodone Hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults.

The exact mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood. It is believed to exert its antidepressant effect by enhancing serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Vilazodone also acts as a partial agonist at serotonin (5-HT) receptors. However, the overall effect of this activity on serotonergic transmission and its contribution to its antidepressant action is not fully established.

Dosage for Treatment of Major Depressive Disorder: The recommended target dosage for vilazodone is 20 mg to 40 mg orally once daily with food. To achieve the target dosage, titrate vilazodone as follows:

• Start with an initial dosage of 10 mg once daily with food for 7 days,
• Then increase to 20 mg once daily with food.
• The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.

If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.

Screen for Bipolar Disorder Prior to Starting vilazodone: Prior to initiating treatment with vilazodone or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

Switching to or from a Monoamine Oxidase Inhibitor Antidepressant: At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of vilazodone. In addition, at least 14 days must elapse after stopping vilazodone before starting an MAOI antidepressant.

Dosage Adjustments with CYP3A4 Inhibitors or Inducers:

• Patients receiving concomitant CYP3A4 inhibitors: During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the vilazodone dose should not exceed 20 mg once daily. The original vilazodone dose level can be resumed when the CYP3A4 inhibitor is discontinued.
• Patients receiving concomitant CYP3A4 inducers: Based on clinical response, consider increasing the dosage of vilazodone by 2-fold, up to a maximum of 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for more than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the vilazodone dosage to its original level over 1 to 2 weeks.

Discontinuing Treatment with vilazodone: Adverse reactions may occur upon discontinuation of vilazodone. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. vilazodone should be down-tapered from 40 mg once daily to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking 20 mg once daily should be tapered to 10 mg once daily for 7 days.

CYP3A4 Inhibitors: The vilazodone dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors.

CYP3A4 Inducers: When used with strong CYP3A4 inducers for more than 14 days, consider increasing vilazodone dose up to two-fold (maximum 80 mg once daily) over 1–2 weeks.

Vilazodone is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including linezolid or intravenous methylene blue, due to the risk of serotonin syndrome.

• Suicidal thoughts and behaviors in adolescents and young adults
• Serotonin syndrome
• Increased risk of bleeding
• Activation of mania or hypomania
• Discontinuation syndrome
• Seizures
• Angle-closure glaucoma
• Hyponatremia
• Sexual dysfunction

There is a pregnancy exposure registry monitoring outcomes in women exposed to antidepressants during pregnancy. There are no data regarding vilazodone in human milk, its effects on the breastfed infant, or on milk production.

Serotonin Syndrome: Risk increases when used with other serotonergic drugs (SSRI, SNRI, triptans, amphetamines) or even alone. Discontinue immediately if it occurs and provide supportive care.

Increased Risk of Bleeding: Risk increases with aspirin, NSAIDs, antiplatelet drugs, warfarin, or other anticoagulants.

Activation of Mania/Hypomania: Screen patients for bipolar disorder before treatment.

Seizures: Use with caution in patients with seizure disorders.

Angle-Closure Glaucoma: Avoid use in patients with untreated narrow-angle glaucoma.

Sexual Dysfunction: May cause sexual dysfunction symptoms.

Pediatric Use: Safety and efficacy in pediatric patients for MDD have not been established.

Geriatric Use: No dose adjustment required based on age. Pharmacokinetics are similar between elderly and younger adults.

Atypical antidepressant drugs

Keep below 30°C, away from light and moisture. Keep out of reach of children.