Drug Monograph
Viibryd (Vilazodone)
vilazodone hydrochloride
Pharmacokinetic Profile
Half-Life
~25 hours
Metabolism
CYP3A4 (major); CYP2C19, CYP2D6 (minor)
Protein Binding
96–99%
Bioavailability
72% (with food)
Volume of Distribution
Large (not precisely quantified)
Clinical Information
Drug Class
SPARI (SSRI + 5-HT1A partial agonist)
Available Doses
10 mg, 20 mg, 40 mg tablets
Route
Oral (once daily with food)
Renal Adjustment
None required (mild–severe)
Hepatic Adjustment
None required (mild–severe, Child-Pugh 5–15)
Pregnancy
Risk of neonatal complications in 3rd trimester
Lactation
No human data; excreted in rat milk
Schedule / Legal Status
Not a controlled substance
Generic Available
Yes
Black Box Warning
Suicidal thoughts & behaviors (pediatric/young adults)
Vilazodone Indications
| Indication | Approved Population | Therapy Type | Status |
|---|---|---|---|
| Major depressive disorder (MDD) | Adults (18+ years) | Monotherapy | FDA Approved |
Vilazodone was approved by the FDA in January 2011 for treatment of major depressive disorder in adults. Its efficacy was established in four randomized, double-blind, placebo-controlled trials (three at 40 mg/day, one evaluating both 20 mg and 40 mg/day) demonstrating statistically significant improvement on the MADRS total score compared with placebo. Vilazodone is not approved for use in pediatric patients; two adequately designed pediatric studies in patients aged 7–17 years failed to demonstrate efficacy for MDD.
Off-Label Uses
Generalized anxiety disorder (GAD) — Evidence quality: Moderate. Three industry-sponsored RCTs found vilazodone 20–40 mg/day produced statistically significant improvement on the Hamilton Anxiety Rating Scale compared with placebo, though effect sizes were small and functional outcomes were inconsistent. Vilazodone is not FDA-approved for GAD.
Obsessive-compulsive disorder (OCD) — Evidence quality: Very low. No controlled clinical trials exist for vilazodone in OCD. Use is based on pharmacological rationale (serotonergic mechanism) and anecdotal reports only.
Vilazodone Dosing
Adult Dosing
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| MDD — new diagnosis, initial treatment | 10 mg once daily | 20–40 mg once daily | 40 mg/day | Titrate: 10 mg × 7 days, then 20 mg × 7 days, then may increase to 40 mg Must take with food; fasting reduces AUC by ~50% |
| MDD — concomitant strong CYP3A4 inhibitor | 10 mg once daily | 20 mg once daily | 20 mg/day | Cap dose at 20 mg/day with ketoconazole, itraconazole, clarithromycin, voriconazole Resume original dose when inhibitor is discontinued |
| MDD — concomitant strong CYP3A4 inducer (>14 days) | 10 mg once daily | 40–80 mg once daily | 80 mg/day | Consider doubling dose over 1–2 weeks based on clinical response Carbamazepine, phenytoin, rifampin; taper back when inducer is stopped |
| MDD — switching from an MAOI | 10 mg once daily | 20–40 mg once daily | 40 mg/day | Wait at least 14 days after stopping the MAOI before starting vilazodone Also wait 14 days after stopping vilazodone before starting an MAOI |
| MDD — discontinuation taper (from 40 mg) | 40 mg → 20 mg × 4 days → 10 mg × 3 days → stop | — | Gradual reduction to minimize discontinuation symptoms From 20 mg: taper to 10 mg × 7 days, then stop | |
Special Populations
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| Elderly (>65 years) | 10 mg once daily | 20–40 mg once daily | 40 mg/day | No pharmacokinetic dose adjustment needed; start conservatively Higher risk of hyponatremia; monitor sodium |
| Renal impairment (mild–severe, GFR 15–90 mL/min) | 10 mg once daily | 20–40 mg once daily | 40 mg/day | No dose adjustment required Unlikely to be dialyzable due to high Vd |
| Hepatic impairment (mild–severe, Child-Pugh 5–15) | 10 mg once daily | 20–40 mg once daily | 40 mg/day | No dose adjustment required per current labeling Clearance not significantly altered across mild, moderate, or severe hepatic impairment |
Clinical Pearl: Food Requirement
Vilazodone must be administered with food. When taken in the fasting state, AUC decreases by approximately 50% and Cmax by approximately 60%, which can result in subtherapeutic concentrations and treatment failure. Counsel patients explicitly about this requirement at every visit.
Pharmacology
Mechanism of Action
Vilazodone enhances serotonergic activity in the central nervous system through a dual mechanism. It potently and selectively inhibits the serotonin transporter (SERT), blocking reuptake of serotonin from the synaptic cleft (Ki = 0.1 nM for the serotonin reuptake site, IC50 = 1.6 nM for reuptake inhibition). Simultaneously, vilazodone acts as a partial agonist at the 5-HT1A receptor (IC50 = 2.1 nM). This combination of actions has led to its classification as a serotonin partial agonist-reuptake inhibitor (SPARI). The 5-HT1A partial agonism may theoretically accelerate antidepressant response by desensitizing presynaptic somatodendritic 5-HT1A autoreceptors, although this has not been consistently demonstrated in clinical trials. Vilazodone has minimal affinity for norepinephrine (Ki = 56 nM) and dopamine (Ki = 37 nM) transporters and does not prolong the QTc interval at doses up to twice the recommended maximum.
ADME Profile
| Parameter | Value | Clinical Implication |
|---|---|---|
| Absorption | Tmax 4–5 h; absolute bioavailability 72% (with food); Cmax increases 147–160% with food vs fasted | Must take with food to achieve therapeutic levels; fasting reduces exposure by ~50% |
| Distribution | Widely distributed; large Vd (not precisely quantified); protein binding 96–99% | High protein binding may displace other highly bound drugs; dialysis ineffective due to large Vd |
| Metabolism | Extensive hepatic metabolism via CYP3A4 (major), CYP2C19 and CYP2D6 (minor), and non-CYP pathways (carboxylesterase); no active metabolites | Dose cap at 20 mg with strong CYP3A4 inhibitors; consider doubling dose with strong CYP3A4 inducers |
| Elimination | t½ ~25 h; steady state in ~3 days; 1% unchanged in urine, 2% in feces | Once-daily dosing; no renal dose adjustment needed even in severe impairment |
Side Effects
≥10%
Very Common
| Adverse Effect | Incidence | Clinical Note |
|---|---|---|
| Diarrhea | 26–29% | Most common reason for early discontinuation; usually transient, peaking in weeks 1–2 and resolving by week 4; dose-independent between 20 and 40 mg |
| Nausea | 22–24% | Dose-independent; improves with continued use; taking with a substantial meal may mitigate severity |
| Headache | 14–15% | Similar to placebo rate (14%); typically mild and self-limiting |
1–10%
Common
| Adverse Effect | Incidence | Clinical Note |
|---|---|---|
| Dry mouth | 7–8% | Comparable to many SSRIs; sugar-free gum or saliva substitutes may help |
| Insomnia | 6–7% | More common than placebo (2%); consider morning dosing if disruptive |
| Dizziness | 6–8% | Dose-related; caution when driving or operating machinery |
| Abdominal pain | 4–7% | Includes upper abdominal pain and abdominal discomfort |
| Somnolence | 4–5% | May improve after initial weeks; additive with other CNS depressants |
| Vomiting | 4–5% | If within 7 hours of dosing, absorption decreased by ~25%; no replacement dose needed |
| Decreased libido | 2–4% | Reported in both males and females; rates may be lower than with traditional SSRIs though head-to-head superiority is not established |
| Erectile dysfunction (males) | 3% | At 40 mg dose; not reported at 20 mg dose |
| Abnormal dreams | 2–3% | Generally non-distressing; more common with 40 mg |
| Restlessness / akathisia | 2–3% | Includes akathisia and restless legs syndrome |
| Flatulence | 3% | Part of the gastrointestinal side effect profile |
| Increased appetite | 3% | At 40 mg; weight gain ≥7% occurred in only 1% (vs 0.4% placebo) |
| Palpitations | 2% | At 40 mg; benign; no QTc prolongation demonstrated |
| Fatigue | 3–4% | Similar to placebo rate (3%) |
Serious
Serious (Regardless of Frequency)
| Adverse Effect | Estimated Frequency | Typical Onset | Required Action |
|---|---|---|---|
| Serotonin syndrome | 0.1% | Hours to days after initiation or dose change; higher risk with drug combinations | Discontinue vilazodone and all serotonergic agents immediately; supportive care; cyproheptadine may be considered |
| Suicidal thoughts and behaviors | Class effect (see boxed warning) | First few months of treatment or after dose changes; highest risk in patients <25 years | Close monitoring of all patients; consider dose reduction or discontinuation if worsening |
| Hyponatremia / SIADH | Rare | Days to weeks; sodium levels can drop below 110 mmol/L | Check sodium if symptomatic (confusion, weakness, seizure); discontinue vilazodone and manage electrolytes |
| Mania / hypomania activation | 0.1% | Days to weeks after initiation | Discontinue vilazodone; screen for bipolar disorder; initiate mood stabilizer if appropriate |
| Abnormal bleeding | Rare (class effect) | Any time during treatment; risk increased with concurrent anticoagulants or NSAIDs | Monitor for bruising, epistaxis, GI bleeding; check INR if on warfarin |
| Seizures | Very rare | Any time during treatment | Discontinue vilazodone; evaluate seizure etiology; prescribe with caution in patients with seizure history |
| Angle-closure glaucoma | Very rare (class effect) | Any time; mydriasis triggers closure in susceptible patients | Avoid in untreated anatomically narrow angles; urgent ophthalmology referral if acute eye pain and vision change |
| Acute pancreatitis | Very rare (postmarketing) | Variable | Discontinue vilazodone; standard pancreatitis management |
Discontinuation
Discontinuation Rates
Adults (Placebo-Controlled Trials)
7.3% vs 3.5% placebo
Top reason: Nausea (1.4%)
Discontinuation Syndrome
~15%
Meta-analysis estimate: approximately 1 in 6–7 patients experience withdrawal symptoms after abrupt cessation of antidepressants
| Reason for Discontinuation | Incidence | Context |
|---|---|---|
| Nausea | 1.4% | Only adverse event causing discontinuation in ≥1% of patients; typically in first 2 weeks |
| Diarrhea | <1% | Despite high incidence rate, most patients tolerate and continue therapy |
| Other GI events | <1% | Vomiting, abdominal pain; rarely severe enough to warrant stopping |
Managing GI Side Effects
Gastrointestinal adverse effects (diarrhea and nausea) are the most clinically important tolerability concern with vilazodone and the primary driver of early discontinuation. Advising patients to take vilazodone with a full meal, to expect transient GI symptoms during the first 1–2 weeks, and to persist through the initial period typically improves long-term adherence. The mandatory titration schedule (10 mg × 7 days, then 20 mg × 7 days) is designed to minimize these effects.
Drug Interactions
Vilazodone is primarily metabolized by CYP3A4, with minor contributions from CYP2C19 and CYP2D6. It does not significantly inhibit or induce most CYP enzymes (potential CYP2C8 inhibition has been identified in vitro but not confirmed clinically). The interactions of greatest clinical concern involve serotonergic drugs, strong CYP3A4 modulators, anticoagulants, and digoxin.
Major
MAOIs (e.g., phenelzine, selegiline, linezolid, IV methylene blue)
MechanismAdditive serotonergic stimulation via reuptake inhibition plus MAO blockade
EffectHigh risk of serotonin syndrome (hyperthermia, rigidity, clonus, autonomic instability)
ManagementAbsolutely contraindicated; 14-day washout required in both directions
FDA PI
Major
Other serotonergic drugs (triptans, SNRIs, TCAs, tramadol, fentanyl, lithium, buspirone, St. John’s Wort)
MechanismCombined serotonergic activity via different pathways
EffectIncreased risk of serotonin syndrome
ManagementMonitor closely for serotonin syndrome signs; use combination only if clinically necessary; discontinue if symptoms emerge
FDA PI
Major
Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, voriconazole)
MechanismInhibition of primary metabolic pathway increases vilazodone exposure by ~50%
EffectElevated vilazodone plasma levels; increased risk of dose-dependent adverse effects
ManagementCap vilazodone dose at 20 mg/day during co-administration; resume original dose when inhibitor is stopped
FDA PI
Moderate
Strong CYP3A4 inducers (carbamazepine, phenytoin, rifampin)
MechanismInduction of CYP3A4 accelerates vilazodone clearance, reducing exposure
EffectPotentially subtherapeutic vilazodone levels and loss of antidepressant effect
ManagementConsider doubling vilazodone dose (up to 80 mg/day) over 1–2 weeks if inducer used >14 days; taper back when inducer stopped
FDA PI
Moderate
Warfarin and anticoagulants / antiplatelet agents
MechanismSerotonin reuptake inhibition depletes platelet serotonin stores, impairing hemostasis
EffectIncreased bleeding risk; ranges from bruising to life-threatening hemorrhage
ManagementMonitor INR when starting, titrating, or stopping vilazodone in patients on warfarin; counsel about bleeding signs
FDA PI
Moderate
Digoxin
MechanismVilazodone increases digoxin exposure (narrow therapeutic index drug)
EffectElevated digoxin levels with risk of toxicity (arrhythmia, GI symptoms, visual disturbance)
ManagementMeasure serum digoxin before starting vilazodone; monitor levels and reduce digoxin dose as necessary
FDA PI
Minor
NSAIDs (aspirin, ibuprofen, naproxen)
MechanismAdditive effects on platelet function and gastric mucosal protection
EffectModestly increased risk of upper GI bleeding
ManagementCounsel patients; consider gastroprotection with PPI if chronic NSAID use
FDA PI
Minor
Highly protein-bound drugs
MechanismVilazodone is 96–99% protein bound; may displace other highly bound agents
EffectTheoretical increase in free fraction of displaced drug
ManagementInteraction not formally studied; monitor clinical effect of narrow-TI drugs
FDA PIMonitoring
-
Suicidality screening
Weekly × 4 weeks, then biweekly × 4 weeks, then as clinically indicated
Routine Assess for emergent suicidal ideation and behavior, especially in patients under 25, at initiation and each dose change. Use validated tools (PHQ-9, C-SSRS) at each visit. -
Depressive symptoms
Every 2–4 weeks during titration, then every 1–3 months
Routine Track treatment response with a standardized rating scale (PHQ-9 or MADRS). Assess at each visit whether target dose has been reached and response is adequate. -
Serum sodium
Baseline in at-risk patients; as clinically indicated
Trigger-based Check in elderly patients, those on diuretics, or volume-depleted patients. Re-check if confusion, weakness, headache, or seizure occur during treatment. -
Bleeding signs
Each visit if on anticoagulants or NSAIDs
Trigger-based Ask about bruising, epistaxis, gum bleeding, melena, or hematuria. Monitor INR in patients on warfarin at initiation, titration, and discontinuation of vilazodone. -
Sexual function
Baseline, then at 4–6 weeks and periodically
Routine Proactively assess at each visit using a brief structured question. Patients rarely volunteer sexual side effects. Compare to baseline function documented before treatment. -
Weight
Baseline, then every 3 months
Routine Vilazodone is generally weight-neutral short-term (mean change 0.2–0.4 kg). Long-term data show a mean gain of 1.7 kg over 52 weeks. Clinically significant weight gain (≥7%) is uncommon (~1%). -
Serotonin syndrome signs
Each visit; especially at initiation and dose changes
Trigger-based Educate patient and family about signs (agitation, clonus, hyperthermia, diaphoresis). Heightened vigilance when co-prescribing other serotonergic agents. -
Digoxin levels
Baseline and after vilazodone initiation
Trigger-based Only relevant in patients co-prescribed digoxin. Measure serum digoxin concentration before and 1–2 weeks after starting vilazodone; reduce digoxin dose as needed.
Contraindications & Cautions
Absolute Contraindications
- Concurrent MAOI use or within 14 days of MAOI discontinuation — includes all MAOIs for psychiatric use plus linezolid and intravenous methylene blue. Risk of fatal serotonin syndrome. No exceptions.
Relative Contraindications (Specialist Input Recommended)
- Bipolar disorder (unscreened or uncontrolled) — Vilazodone may precipitate manic or mixed episodes. Screen for bipolar spectrum before initiating. If bipolar is identified, antidepressant monotherapy is generally inappropriate without a mood stabilizer, and specialist input is advised.
- Untreated anatomically narrow angles — Antidepressant-induced mydriasis may trigger angle-closure glaucoma. Ophthalmology assessment recommended before initiation.
- Active or recent significant bleeding — Given serotonin-mediated platelet impairment, use requires a documented risk-benefit discussion, especially when combined with anticoagulants.
Use with Caution
- Seizure disorder — Patients with a history of seizures were excluded from clinical trials. Prescribe with caution and monitor seizure frequency.
- Elderly patients or patients on diuretics — Greater risk of hyponatremia. Monitor sodium baseline and symptomatically.
- Patients requiring reliable medication without food — Food-dependent absorption makes vilazodone a poor choice for patients who cannot reliably take medication with a meal.
- Third trimester pregnancy — Risk of neonatal complications (respiratory distress, feeding difficulty, PPHN) and postpartum hemorrhage.
FDA Boxed Warning
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. In pooled analyses of approximately 77,000 adult and over 4,500 pediatric patients across all antidepressant classes, there were 14 additional cases per 1,000 patients under 18 years and 5 additional cases per 1,000 patients aged 18–24 compared with placebo. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of therapy and at times of dosage changes. Vilazodone is not approved for use in pediatric patients.
Patient Counselling
Purpose of Therapy
Vilazodone is prescribed to treat major depressive disorder. It works by increasing serotonin activity in the brain through two complementary actions. Full therapeutic benefit typically takes 4–8 weeks to develop, although some improvement may be noticed earlier. Continuing the medication as directed even after feeling better is important to prevent relapse.
How to Take
Take vilazodone once daily with food — this is essential because taking it on an empty stomach cuts the amount of medication your body absorbs by roughly half. Swallow the tablet whole. Take it at the same time each day. If you miss a dose, take it as soon as you remember unless it is nearly time for the next dose; never double up. Do not stop taking vilazodone abruptly, as withdrawal-like symptoms can occur.
Nausea & Diarrhea
Tell patient
Stomach upset and loose stools are very common during the first 1–2 weeks and usually improve with continued use. Taking the medication with a full meal (not just a snack) and following the gradual dose increase schedule helps reduce these effects.
Call prescriber
If diarrhea is severe, persistent beyond 2–3 weeks, causes dehydration, or is accompanied by fever or blood in the stool.
Drowsiness & Dizziness
Tell patient
Some patients experience sleepiness or light-headedness, especially at higher doses. Avoid driving or operating heavy machinery until you know how the medication affects you. Avoid alcohol, which can worsen these effects.
Call prescriber
If drowsiness is severe enough to impair daily functioning or if dizziness does not improve after the first few weeks.
Food Requirement
Tell patient
Always take vilazodone with food. Without food, your body absorbs only about half the dose, which can make the medication less effective. A meal of any size is sufficient — high-fat meals boost absorption the most, but any food is far better than none.
Call prescriber
If you are unable to eat regularly (due to illness, nausea, or other reasons) and are missing doses with food for several days.
Sexual Side Effects
Tell patient
Changes in sexual desire, arousal, or orgasm can occur with vilazodone, though rates may be lower than with some other antidepressants. These effects are important to discuss openly so that management strategies can be explored if needed.
Call prescriber
If sexual side effects are bothersome or affecting quality of life or relationships. Dose reduction, timing changes, or medication switch may be options.
Mood Changes & Suicidal Thoughts
Tell patient
In rare cases, antidepressants can initially worsen mood or cause new feelings of anxiety, agitation, or thoughts of self-harm, particularly in the first few weeks or after a dose change. This is more common in younger patients but should be monitored in everyone.
Call prescriber
Immediately if you experience new or worsening depression, thoughts of suicide, unusual agitation, impulsive behavior, or marked anxiety. Seek emergency care if you feel unsafe.
Discontinuation
Tell patient
Do not stop vilazodone suddenly. Abrupt discontinuation can cause dizziness, nausea, irritability, electric shock sensations, and anxiety. When it is time to stop, your prescriber will taper the dose gradually over about one week.
Call prescriber
If you have run out of medication or accidentally stopped taking it, or if you are experiencing withdrawal symptoms after a missed dose.
Serotonin Syndrome Warning
Tell patient
A rare but serious condition called serotonin syndrome can occur, especially when vilazodone is combined with other medications that raise serotonin (including certain migraine drugs, pain medications, and herbal supplements like St. John’s Wort). Always inform all your healthcare providers that you take vilazodone.
Call prescriber
Seek emergency care if you develop agitation, confusion, rapid heartbeat, high fever, muscle twitching, or severe diarrhea with these combinations.
Sources
Regulatory (PI / SmPC)
- AbbVie Inc. VIIBRYD (vilazodone hydrochloride) tablets, for oral use. Full prescribing information. Revised 10/2023. FDA Label Primary source for all dosing, adverse reaction incidence rates, drug interactions, contraindications, and pharmacokinetic parameters cited in this monograph.
- DailyMed. Vilazodone hydrochloride tablet, film coated — drug label information. National Library of Medicine. DailyMed Supplementary generic labeling source providing identical prescribing data for the generic formulation.
Key Clinical Trials
- Rickels K, Athanasiou M, Robinson DS, et al. Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(3):326–333. doi:10.4088/JCP.08m04637 Pivotal Phase III trial (Study 1) demonstrating efficacy of vilazodone 40 mg/day versus placebo in MDD.
- Khan A, Cutler AJ, Kajdasz DK, et al. A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorder. J Clin Psychiatry. 2011;72(4):441–447. doi:10.4088/JCP.10m06596 Second pivotal Phase III trial (Study 2) confirming vilazodone 40 mg/day superiority over placebo on MADRS.
- Croft HA, Pomara N, Gommoll C, Chen D, Nunez R, Mathews M. Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014;75(11):e1291–e1298. doi:10.4088/JCP.14m08992 Phase IV trial (Study 3) with the largest effect size among vilazodone RCTs (MADRS difference –5.1).
- Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015;30(2):67–74. doi:10.1097/YIC.0000000000000057 Phase IV trial (Study 4) establishing efficacy of both the 20 mg and 40 mg daily doses, supporting the 20–40 mg target range.
- Gommoll C, Forero G, Mathews M, et al. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015;30(6):297–306. doi:10.1097/YIC.0000000000000095 Positive RCT supporting off-label use of vilazodone 20–40 mg/day for GAD, though effect size was small.
Guidelines
- Lam RW, Kennedy SH, Adams C, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 update on clinical guidelines for management of major depressive disorder in adults. Can J Psychiatry. 2024;69(9):641–687. doi:10.1177/07067437241245384 Current major guideline positioning vilazodone among first-line antidepressant options for MDD in adults.
Mechanistic / Basic Science
- Sahli ZT, Banerjee P, Tarazi FI. The preclinical and clinical effects of vilazodone for the treatment of major depressive disorder. Expert Opin Drug Discov. 2016;11(5):515–523. doi:10.1517/17460441.2016.1160051 Review of vilazodone’s dual SSRI/5-HT1A partial agonist mechanism and preclinical pharmacology supporting clinical development.
- Cruz MP. Vilazodone HCl (Viibryd): a serotonin partial agonist and reuptake inhibitor for the treatment of major depressive disorder. P T. 2012;37(1):28–31. PMC3278186 Early clinical overview summarizing the SPARI mechanism, pivotal trial results, and initial safety profile.
Pharmacokinetics / Special Populations
- Boinpally R, Gad N, Engelen S, et al. Pharmacokinetics of vilazodone in patients with mild or moderate renal impairment. Clin Drug Investig. 2013;33(3):199–206. doi:10.1007/s40261-013-0061-5 Phase I study confirming no clinically meaningful change in vilazodone pharmacokinetics in mild-to-moderate renal impairment.
- Chauhan M, Parry R, Bobo WV. Vilazodone for major depression in adults: pharmacological profile and an updated review for clinical practice. Neuropsychiatr Dis Treat. 2022;18:1175–1193. doi:10.2147/NDT.S279342 Comprehensive clinical review covering pharmacokinetics, drug interactions, efficacy data, and special population considerations.
- Robinson DS, Kajdasz DK, Gallipoli S, et al. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011;31(5):643–646. doi:10.1097/JCP.0b013e31822c6741 Long-term (52-week) open-label safety study providing discontinuation rate data and weight change findings over sustained treatment.
- Wagner G, Schultes MT, Titscher V, et al. Efficacy and safety of levomilnacipran, vilazodone and vortioxetine compared with other second-generation antidepressants for major depressive disorder in adults: a systematic review and network meta-analysis. J Affect Disord. 2018;228:1–12. doi:10.1016/j.jad.2017.11.056 Network meta-analysis positioning vilazodone relative to other newer antidepressants for efficacy and tolerability.