Vilazodone

The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT 1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

• Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults (1).ICD-10: F32.9

• Vilazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4).contraindicated

• Recommended target dosage: 20 mg to 40 mg once daily with food (2.1, 12.3). • To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases (2.1). • Prior to initiating vilazodone hydrochloride tablets, screen for bipolar disorder (2.2, 5.4). • When discontinuing vilazodone hydrochloride tablets, reduce the dosage gradually (2.4, 5.5). 2.1 Dosage for Treatment of Major Depressive Disorder The recommended target dosage for vilazodone hydrochloride tablet is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve the target dosage, titrate vilazodone hydrochloride tablet 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. 2.2 Screen for Bipolar Disorder Prior to Starting Vilazodone Hydrochloride Tablets Prior to initiating treatment with vilazodone hydrochloride tablet or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].

• Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans, amphetamines), but also when taken alone. If it occurs, discontinue vilazodone hydrochloride tablets and initiate supportive treatment (5.2). • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.3). • Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.4). • Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder (5.6). • Angle Closure Glaucoma: Avoid use of antidepressants, including vilazodone hydrochloride tablets, in patients with untreated anatomically narrow angles (5.7). • Sexual Dysfunction: Vilazodone hydrochloride tablets may cause symptoms of sexual dysfunction (5.9). 5.1 Suicidal Thoughts and Behavior in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater in antidepressant-treated patients than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)]. • Serotonin Syndrome [see Warnings and Precautions (5.2)]. • Increased Risk of Bleeding [see Warnings and Precautions (5.3)]. • Activation of Mania or Hypomania [see Warnings and Precautions (5.4)]. • Discontinuation Syndrome [see Warnings and Precautions (5.5)]. • Seizures [see Warnings and Precautions (5.6)]. • Angle-Closure Glaucoma [see Warnings and Precautions (5.7)]. • Hyponatremia [see Warnings and Precautions (5.8)]. • Sexual Dysfunction [see Warnings and Precautions (5.9)]. Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The most commonly observed adverse reactions in vilazodone hydrochloride tablets-treated with major depressive disorder MDD in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.

• Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn (8.1). 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary There are no adequate and well-controlled studies of vilazodone hydrochloride tablets in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. In animal reproduction studies, oral administration of vilazodone during the period of organogenesis at doses up to 48 and 17 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively, resulted in decreased fetal body weight gain and delayed skeletal ossification but no teratogenic effects were observed.

Metabolism

Vilazodone activity is due primarily to the parent drug. The pharmacokinetics of vilazodone (5 mg to 80 mg) are dose-proportional.

There is limited clinical trial experience regarding human overdose with vilazodone hydrochloride tablets. The adverse reactions associated with overdose of vilazodone hydrochloride tablets at doses of 200 to 280 mg (5 to 7 times the recommended dosage) as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation. For current information on the management of poisoning or overdose, contact a poison control center at 1-800-222-1222. No specific antidotes for vilazodone are known. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

• Jan 21, 2011NDANDA022567Abbvie
• Sep 30, 2019ANDAANDA208212Teva Pharms Usa
• Jan 10, 2020ANDAANDA208202Alembic
• Apr 7, 2021ANDAANDA208200Invagen Pharms
• Apr 27, 2021ANDAANDA208209Accord Hlthcare
• Jul 7, 2023ANDAANDA208228Apotex

1. 1Off Label Use1,08012%
2. 2Diarrhoea7738.5%
3. 3Nausea7698.4%
4. 4Anxiety6347.0%
5. 5Insomnia6136.7%
6. 6Drug Ineffective5566.1%
7. 7Headache5345.9%
8. 8Depression4895.4%
9. 9Dizziness4805.3%
10. 10Fatigue4535.0%
11. 11Suicidal Ideation4154.6%
12. 12Feeling Abnormal4004.4%
13. 13Weight Increased2963.3%
14. 14Paraesthesia2953.2%
15. 15Vomiting2703.0%

Recent PubMed references pinned to Vilazodone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Sexually dimorphic and time-dependent influence of active avoidance learning by vilazodone in C57BL/6J mice.
  Acta pharmaceutica (Zagreb, Croatia) · 2026 · Hu K, Zhang A, Shi Y, et al.
  PMID 41885694DOI 10.2478/acph-2026-0007
• Onvansertib and vilazodone inhibit SARS-CoV-2 replication via suppression of METTL3 RNA-m(6)A enzymatic activity.
  Antiviral research · 2026 · Zhang T, Wang ZL, Li XY, et al.
  PMID 41722706DOI 10.1016/j.antiviral.2026.106376
• Structural basis of vilazodone dual binding mode to the serotonin transporter.
  Nature communications · 2025 · Kalenderoglou IE, Nygaard A, Vogt CD, et al.
  PMID 41253806DOI 10.1038/s41467-025-65202-3
• Vilazodone ameliorates senescence-related Alzheimer's disease like symptoms by targeting Plau to induce autophagy in senescent cells.
  International immunopharmacology · 2025 · Sun W, Sheng X, Li R, et al.
  PMID 40690806DOI 10.1016/j.intimp.2025.115251
• Vilazodone exposure during pregnancy: Effects on embryo-fetal development, pregnancy outcomes and fetal neurotoxicity by BDNF/Bax-Bcl2/5-HT mediated mechanisms.
  Neurotoxicology · 2024 · Agrawal P, Singh P, Singh KP, et al.
  PMID 39532268DOI 10.1016/j.neuro.2024.10.012
• Vilazodone, a Novel SSRI Antidepressant with 5-HT1A Partial Agonist Properties: Diminished Potentiation of Chronic Oral Methylphenidate-Induced Dynorphin Expression in the Striatum in Adolescent Male Rats.
  Molecular neurobiology · 2025 · Hrabak M, Ahmed R, Soriano MG, et al.
  PMID 39466575DOI 10.1007/s12035-024-04569-8
• Prenatal exposure to vortioxetine and vilazodone: Impact on depressive- and anxiety-like behavioral manifestations in young rat offspring.
  Behavioural brain research · 2024 · Singh P, Agrawal P, Singh KP, et al.
  PMID 38945303DOI 10.1016/j.bbr.2024.115128
• Design of vilazodone-donepezil chimeric derivatives as acetylcholinesterase inhibitors by QSAR, molecular docking and molecular dynamics simulations.
  Physical chemistry chemical physics : PCCP · 2024 · Guo L, Chang Z, Tong J, et al.
  PMID 38896464DOI 10.1039/d4cp01741b

The 10 most recently updated of 34 ClinicalTrials.gov registrations naming Vilazodone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Department of Defense PTSD Adaptive Platform Trial - Master Protocol
  Recruiting · Phase 2 · Interventional · 800 enrolled · Global Coalition for Adaptive Research
  NCT05422612updated 2026-06-05
• Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone
  Not yet recruiting · Phase 2 · Interventional · 200 enrolled · Global Coalition for Adaptive Research
  NCT05948579updated 2026-05-20
• Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression
  Not yet recruiting · Phase 2 · Interventional · 80 enrolled · University of Illinois at Chicago
  NCT06591091updated 2025-09-04
• A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
  Completed · Phase 2 · Interventional · 107 enrolled · Janssen Research & Development, LLC
  NCT03321526updated 2025-04-29
• Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
  Terminated · Observational · 1,037,352 enrolled · University of New Mexico
  NCT02893371updated 2024-03-12
• Double-Blind Treatment of Major Depressive Disorder With Vilazodone
  Completed · Phase 2 · Interventional · 79 enrolled · University of Chicago
  NCT01742832updated 2023-02-23
• Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
  Completed · Phase 3 · Interventional · 529 enrolled · Forest Laboratories
  NCT01878292updated 2019-12-24
• Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
  Completed · Phase 3 · Interventional · 415 enrolled · Forest Laboratories
  NCT01844115updated 2019-12-18
• Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
  Completed · Phase 3 · Interventional · 402 enrolled · Forest Laboratories
  NCT01766401updated 2019-12-18
• Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
  Completed · Phase 3 · Interventional · 680 enrolled · Forest Laboratories
  NCT01629966updated 2019-12-18

CPIC-curated drug–gene pairs for Vilazodone. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• HTR2ACPIC C
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants
• SLC6A4CPIC C
  CYP2D6, CYP2C19, CYP2B6, SLC6A4, HTR2A and Serotonin Reuptake Inhibitor Antidepressants

Frequently asked questions

How does Vilazodone work?

The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT 1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

What is Vilazodone used for?

According to FDA labeling, Vilazodone carries indications including: Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults (1).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vilazodone?

Vilazodone is classified as Other antidepressants, Monoamine Oxidase Inhibitors, Serotonin Uptake Inhibitors, Increased Central Nervous System Serotonin Activity.

What are the brand names for Vilazodone?

Vilazodone is marketed under brand names including Viibryd.

What are the contraindications for Vilazodone?

Vilazodone labeling lists contraindications including: Vilazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4).. Always consult the full prescribing information and a clinician.