VIIBRYD vilazodone hydrochloride 20 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other antidepressants class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Vilazodone — brand name Viibryd — is an antidepressant approved to treat major depressive disorder (MDD) in adults. MDD is a clinical condition, not just ordinary sadness, and it c...
- Yes, this one genuinely matters. If you take vilazodone without food, your body may absorb up to 50% less of the drug — which could make it significantly less effective. Try to tak...
- Does it really matter if I take it with food?
- The most common ones are digestive: diarrhea, nausea, and sometimes vomiting — especially in the first few weeks. Insomnia, headache, and dizziness are also possible. These often i...
Patient education
Supplement & herbal interactions
Vilazodone may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $12.189 | $365.66 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $11.57 | $347.03 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $12.47 | $373.98 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vilazodone Hydrochloride 20 mg 00480-2044-56 | Teva | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| vilazodone hydrochloride 20 mg 60505-4373-03 | Apotex | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| Vilazodone Hydrochloride 20 mg 62332-0233-30 | Alembic | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| Vilazodone hydrochloride 20 mg 69097-0981-02 | Cipla | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| vilazodone hydrochloride 20 mg 72205-0261-30 | Novadoz | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| vilazodone hydrochloride 20 mg 72603-0814-01 | Northstar | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| Vilazodone hydrochloride 20 mg 76282-0545-30 | Exelan | 30 tablets | $0.735 | AB | Availability likely | save 94% |
| Vilazodone Hydrochloride 20 mg 16729-0353-10 | Accord | 30 tablets | $0.858 | AB | Availability likely | save 93% |
| Viibryd 20 mgthis 00456-1120-30 | Allergan, | 30 tablets | $12.189 | AB | Availability likely | — |
| Vilazodone Hydrochloride 20 mg 46708-0233-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| Vilazodone Hydrochloride 20 mg 51407-0916-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| vilazodone hydrochloride 20 mg 68788-8734-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00456-1120-30 You're viewing this | 30 TABLET in 1 BOTTLE (0456-1120-30) | 2011-04-29 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavi ors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . V IIBRYD is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ). Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).
Viibryd is not approved for use in pediatric patients ( 8.4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VIIBRYD ® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. VIIBRYD is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 VIIBRYD, screen for bipolar disorder ( 2.2 , 5.4 ) When discontinuing VIIBRYD, reduce dosage gradually ( 2.4 , 5.5 )
2.1Dosage for Treatment of Major Depressive Disorder The recommended target dosage for VIIBRYD 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 VIIBRYD 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.
2.2Screen for Bipolar Disorder Prior to Starting VIIBRYD Prior to initiating treatment with VIIBRYD or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.4 )] . 2. 3 Switching t o or f rom a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of VIIBRYD.
In addition, at least 14 days must elapse after stopping VIIBRYD before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ) ]. 2. 4 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 VIIBRYD dose should not exceed 20 mg once daily.
The original VIIBRYD dose level, can be resumed when the CYP3A4 inhibitor is discontinued [see Drug Interactions ( 7 )] . Patients receiving concomitant CYP3A4 inducers : Based on clinical response, consider increasing the dosage of VIIBRYD by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the VIIBRYD dosage to its original level over 1 to 2 weeks [see Drug Interactions ( 7 )] .
2. 5 Discontinuing Treatment with VIIBRYD Adverse reactions may occur upon discontinuation of VIIBRYD [see Warnings and Precautions ( 5.5 )] . A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
VIIBRYD should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking VIIBRYD 20 mg once daily should be tapered to 10 mg once daily for 7 days.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets. 10 mg pink, oval tablet, debossed with 10 on one side 20 mg orange, oval tablet, debossed with 20 on one side 40 mg blue, oval tablet, debossed with 40 on one side Tablets: 10 mg, 20 mg, and 40 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS VIIBRYD is 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue VIIBRYD and serotonergic agents 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 VIIBRYD, in patients with untreated anatomically narrow angles ( 5.7 ) Sexual Dysfunction: VIIBRYD may cause symptoms of sexual dysfunction ( 5.9 )
5.1Suicidal 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.
There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patient s with Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18-24 5 additional patients Decreases Compared to Placebo 25-64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.
However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.
Consider changing the therapeutic regimen, including possibly discontinuing VIIBRYD, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2Serotonin Syndrome Serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitor (SSRIs), including VIIBRYD, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4 ) and Drug Interactions ( 7 ) ] .
Serotonin syndrome can also occur when these drugs are used alone. Symptoms of serotonin syndrome were noted in 0.1% of MDD patients treated with VIIBRYD in premarketing clinical trials. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitati…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 AbbVie Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 VIIBRYD-treated patients 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.
Patient Exposure The safety of VIIBRYD was evaluated in 3,007 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to VIIBRYD for a total of 348 patient-years. The adverse reaction information presented below was derived from studies of VIIBRYD 20 mg and 40 mg daily in patients with MDD including: Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 VIIBRYD-treated patients; and An open-label 52-week study of 599 VIIBRYD-treated patients.
These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, VIIBRYD was administered with food. Adverse reactions reported as reasons for discontinuation of treatment In these studies, 7.3% of the VIIBRYD-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients.
The most common adverse reaction leading to discontinuation in at least 1% of the VIIBRYD-treated patients in the placebo-controlled studies was nausea (1.4%). Common adverse reactions in placebo-controlled MDD studies Table 2 shows the incidence of common adverse reactions occurring in ≥ 2% of VIIBRYD-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.
Table 2: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients System Organ Class Preferred Term Placebo N=967 VIIBRYD 20 mg/day N=288 VIIBRYD 40 mg/day N=978 Gastrointestinal disorders Diarrhea 10% 26% 29% Nausea 7% 22% 24% Dry mouth 5% 8% 7% Vomiting 2% 4% 5% Abdominal pain 1 3% 7% 4% Dyspepsia 2% 2% 3% Flatulence 1% 3% 3% Gastroenteritis 1% 1% 2% Abdominal distension 1% 2% 1% Nervous system disorders Headache 2 14% 15% 14% Dizziness 5% 6% 8% Somnolence 2% 4% 5% Paresthesia 1% 1% 2% Psychiatric disorders Insomnia 2% 7% 6% Abnormal dreams 2% 2% 3% Restlessness 3 1% 2% 3% General disorders Fatigue 3% 4% 3% Cardiac disorders Palpitations <1% 1% 2% Metabolism and nutrition disorders Increased appetite 1% 1% 3% Musculoskeletal and connective tissue disorders Arthralgia 1% 2% 1% Investigations Increased weight 1% 1% 2% 1 Includes abdominal discomfort, abdominal pain upp…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CYP3A4 Inhibitors: The VIIBRYD dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors ( 2.4 , 7 ). CYP3A4 Inducers: Consider increasing VIIBRYD dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days ( 2.4 , 7 ).
7.1Drugs Having Clinically Important Interactions With VIIBRYD Table 4: Clinically Important Drug Interactions with VIIBRYD Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including VIIBRYD increases the risk of serotonin syndrome. VIIBRYD is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications ( 4 ), Dos age and Administration ( 2.3 ) , and Warnings and Precautions ( 5.2 )].
Other Serotonergic Drugs Concomitant use of VIIBRYD with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during VIIBRYD initiation.
If serotonin syndrome occurs, consider discontinuation of VIIBRYD and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )]. Antiplatelet Agents and Anticoagulants Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with VIIBRYD may potentiate the risk of bleeding.
Inform patients of the increased risk of bleeding with the concomitant use of VIIBRYD and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating, titrating, or discontinuing VIIBRYD [see Warnings and Precautions ( 5.3 )]. Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin, voriconazole) The concomitant use of VIIBRYD and strong CYP3A4 inhibitors increased the exposure of vilazodone compared to the use of VIIBRYD alone [see Clinical Pharmacology ( 12.3 )].
The VIIBRYD dose should not exceed 20 mg once daily with the concomitant use of a strong CYP3A4 inhibitor [see Dosage and Administration ( 2.4 ) , Clinical Pharmacology ( 12.3 ) ] . Strong CYP3A4 Inducers (e.g., carbamazepine, phenytoin, rifampin) The concomitant use of VIIBRYD and strong CYP3A4 inducers decreased the exposure of vilazodone compared to the use of VIIBRYD alone [see Clinical Pharmacology ( 12.3 )]. Based on clinical response, consider increasing the dosage of VIIBRYD, over 1 to 2 weeks in patients taking strong CYP3A4 inducers for greater than 14 days [see Dosage and Administration ( 2.4 ) , Clinical Pharmacology ( 12.3 ) ].
Digoxin Digoxin is a narrow therapeutic index drug. Concomitant use of VIIBRYD increased digoxin concentrations [see Clinical Pharmacology ( 12.3 )] . Measure serum digoxin concentrations before initiating concomitant use of VIIBRYD.
Continue monitoring and reduce digoxin dose as necessary.
7.2Drugs Having No Clinically Important Interactions With VIIBRYD Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are substrates of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and/or P-glycoprotein (except narrow therapeutic index drugs, e.g., digoxin), when VIIBRYD is administered concomitantly [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn ( 8.1 ).
8.1Pregnancy 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 advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 ) and Clinical Considerations] .
There are no adequate and well-controlled studies of VIIBRYD 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 2-4% and of miscarriage is 15-20% 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. Decreased fetal body weight and delayed skeletal ossification were not observed at doses up to 10 and 4 times the MRHD in rats and rabbits, respectively [see Data] . Clinical Considerations Disease-associated m aternal and/or e mbryo/ f etal r isk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of VIIBRYD in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] .
Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including VIIBRYD, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to VIIBRYD in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [ see Data]. Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.
These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [ see Warnings and Precautions ( 5.2 )]. Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).
PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 37…
🤰 Pregnancy ▾
8.1Pregnancy 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 advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 ) and Clinical Considerations] .
There are no adequate and well-controlled studies of VIIBRYD 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 2-4% and of miscarriage is 15-20% 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. Decreased fetal body weight and delayed skeletal ossification were not observed at doses up to 10 and 4 times the MRHD in rats and rabbits, respectively [see Data] . Clinical Considerations Disease-associated m aternal and/or e mbryo/ f etal r isk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of VIIBRYD in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] .
Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including VIIBRYD, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to VIIBRYD in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [ see Data]. Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.
These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [ see Warnings and Precautions ( 5.2 )]. Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).
PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of VIIBRYD have not been established in pediatric patients for the treatment of MDD. Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1002 pediatric patients ages 7 years to 17 years of age with MDD. The following adverse reactions were reported in at least 5% of pediatric patients treated with VIIBRYD and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions ( 5.1 ) , and Adverse Reactions ( 6.2 ) ] . Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were treated with vilazodone (10, 50, and 200 mg/kg/day) starting on postnatal day (PND) 21 through 90. A delay in the age of attainment of vaginal patency (i.e. sexual maturation) was observed in females starting at 50 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 10 mg/kg/day.
This NOAEL was associated with AUC levels similar to those measured at a maximum dose tested in pediatrics (30 mg). Adverse behavioral effects (lack of habituation in an acoustic startle test) were observed in males at 200 mg/kg and females starting at 50 mg/kg both during drug treatment and the recovery periods. The NOAEL for this finding was 50 mg/kg for males and 10 mg/kg for females, which was associated with AUC levels greater than (males) or similar (females), to those observed with the maximum dose tested in pediatric patients.
An 8% decrease in femur mineral density was observed in female rats at 200 mg/kg, compared to the control group. The NOAEL for this finding was 50 mg/kg, which was associated with an AUC level greater than those measured at the maximum dose tested in pediatrics.
🧓 Geriatric Use ▾
8.5Geriatric Use Based on a pharmacokinetic study, no dosage adjustment of VIIBRYD is recommended on the basis of age (see Figure 3). Results from pharmacokinetic study of a single 20 mg VIIBRYD dose in geriatric subjects (> 65 years-old) vs. younger subjects (24-55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups [see Clinical Pharmacology ( 12.3 )]. Clinical studies of VIIBRYD did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Of the 3,007 patients in clinical studies with VIIBRYD, 65 (2.2%) were 65 years of age or older, and 378 (12.6%) were 55 to 64 years 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. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.8 )] .
No other differences in adverse reactions were observed between geriatric and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE There is limited clinical trial experience regarding human overdose with VIIBRYD. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY Figure 1. Effect of Other Drugs on Vilazodone Pharmacokinetics Figure 2. Impact of Vilazodone on Other Drug Pharmacokinetics Figure 3: Impact of Intrinsic Factors on Vilazodone Pharmacokinetics
12.1Mechanism of action 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.
12.2Pharmacodynamics Vilazodone binds with high affinity to the serotonin reuptake site (Ki= 0.1 nM), but not to the norepinephrine (Ki=56 nM) or dopamine (Ki=37 nM) reuptake sites. Vilazodone potently and selectively inhibits reuptake of serotonin (IC 50 = 1.6 nM). Vilazodone also binds selectively with high affinity to 5-HT 1A receptors (IC 50 =2.1 nM) and is a 5-HT 1A receptor partial agonist.
Cardiac Electrophysiology Treatment with VIIBRYD did not prolong the QTc interval. The effect of VIIBRYD [20, 40, 60, and 80 mg (2 times the recommended dosage)] on the QTc interval was evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg), parallel-group, thorough QTc study in 157 healthy subjects. The study demonstrated an ability to detect small effects.
The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 msec, based on the individual correction method (QTcI). Thus, at doses of 2 times the recommended dosage, VIIBRYD did not prolong the QTc interval to a clinically relevant extent.
12.3Pharmacokinetics Vilazodone activity is due primarily to the parent drug. The pharmacokinetics of vilazodone (5 mg – 80 mg) are dose-proportional. Accumulation of vilazodone after administration of single VIIBRYD doses did not vary with dose, and steady-state was achieved in about 3 days.
Elimination of vilazodone is primarily by hepatic metabolism with a terminal half-life of approximately 25 hours. At steady-state, after daily dosing of VIIBRYD 40 mg under fed conditions, the mean C max value was 156 ng/mL, and the mean AUC ( 0-24 hours ) value was 1645 ng·h/mL. Absorption Vilazodone concentrations peaked at a median of 4-5 hours (T max ) after VIIBRYD administration and declined with a terminal half-life of approximately 25 hours.
The absolute bioavailability of vilazodone was 72% with food.Vilazodone AUC and C max in the fasted state can be decreased by approximately 50% and 60%, respectively, compared to the fed state. Administration without food can result in inadequate drug concentrations and may reduce effectiveness. Coadministration of VIIBRYD with ethanol or with a proton pump inhibitor (pantoprazole) did not affect the rate or extent of vilazodone absorption.
In addition, neither the T max nor terminal elimination rate of vilazodone was altered by coadministration with either pantoprazole or ethanol. Absorption is decreased by approximately 25% if vomiting occurs within 7 hours of ingestion; no replacement dose is needed. Distribution Vilazodone is widely distributed and approximately 96-99% protein-bound.
Administration of VIIBRYD to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, because vilazodone is highly bound to plasma protein. The interaction between vilazodone and other highly protein-bound drugs has not been evaluated. Metabolism and Elimination VIIBRYD is extensively metabolized through CYP and non-CYP pathways (possibly by carboxylesterase), with only 1% of the dose recovered in the urine and 2% of the dose recovered in the feces as unchanged vilazodone.
CYP3A4 is primarily responsible for its metabolism among CYP pathways, with minor contributions from CYP2C19 and CYP2D6. Drug…
🧬 Mechanism of Action ▾
12.1Mechanism of action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code 10 mg pink, oval tablet debossed with 10 on one side Bottle / 30 count 0456-1110-30 20 mg orange, oval tablet debossed with 20 on one side Bottle / 30 count 0456-1120-30 40 mg blue, oval tablet debossed with 40 on one side Bottle / 30 count 0456-1140-30 VIIBRYD (vilazodone HCl) Patient Starter Kits are supplied in the following configuration: Package Configuration Tablet Strength Tablet Color/Shape Tablet Markings NDC Code Patient Starter Kit containing seven 10 mg tablets, seven 20 mg tablets and sixteen 40 mg tablets 10 mg pink, oval tablet debossed with 10 on one side 0456-1100-31 20 mg orange, oval tablet debossed with 20 on one side 40 mg blue, oval tablet debossed with 40 on one side Patient Starter Kit containing seven 10 mg tablets, twenty-three 20 mg tablets 10 mg pink, oval tablet debossed with 10 on one side 0456-1101-30 20 mg orange, oval tablet debossed with 20 on one side Store tablets at 25 o C (77°F).
Excursions permitted to 15 o C - 30 o C (59°F - 86°F) [ see USP Controlled Room Temperature ].
📋 Description ▾
11 DESCRIPTION VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99.
The structural formula is: VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only). The structural formula for Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1).
Its molecular weight is 477.99.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Dos age and Administration Instruct patients to take VIIBRYD with food and to follow prescribed dosage instructions [see Dosage and Administration ( 2.1 , 2.3 , 2.4 , 2.5 )].
Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of VIIBRYD with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 )].
Increased Risk of Bleeding Inform patients about the concomitant use of VIIBRYD with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake (e.g., VIIBRYD) and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.3 )].
Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome Advise patients not to abruptly discontinue VIIBRYD and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when VIIBRYD is discontinued [see Warnings and Precautions ( 5.5 )].
Seizures Caution patients about using VIIBRYD if they have a history of a seizure disorder [see Warnings and Precautions ( 5.6 )]. Sexual Dysfunction Advise patients that use of VIIBRYD may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [ see Warnings and Precautions ( 5.9 )] .
Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reaction s ( 6.2 )] . Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions ( 7.1 )]. Pregnancy Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with VIIBRYD [see Use in Specific Populations ( 8.1 )] .
Advise patients that VIIBRYD use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )]. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VIIBRYD during pregnancy [see Use in Specific Populations ( 8.1 )] . Distributed by AbbVie Inc.
1 N Waukegan Rd. North Chicago, IL 60064 Licensed from Merck KGaA, Darmstadt, Germany © 2023 AbbVie. All rights reserved.
VIIBRYD and its design are trademarks of Alle…
💬 Medication Guide ▾
MEDICATION GUIDE VIIBRYD ® (vī-brid) (vilazodone hydrochloride) Tablets, for oral use What is the most important information I should know about VIIBRYD? VIIBRYD may cause serious side effects, including: Increased risk of suicidal thoughts or actions in some children, adolescents, and young adults. VIIBRYD and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
VIIBRYD is not for use in children. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a higher risk of having suicidal thoughts or actions.
These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness) or have a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive, being angry or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) acting on dangerous impulses thoughts about suicide or dying new or worse anxiety feeling agitated or restless trouble sleeping (insomnia) other unusual changes in behavior or mood What is VIIBRYD?
VIIBRYD is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if VIIBRYD is safe and effective for use in children for the treatment of MDD. Who should not take VIIBRYD?
Do not take VIIBRYD if you: take a Monoamine Oxidase Inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with VIIBRYD. Before taking VIIBRYD, tell your healthcare provider about all your medical conditions, including if you: have or have a family history of suicide, depression, bipolar disorder, mania or hypomania have or had bleeding problems have or had seizures or convulsions have high pressure in the eye (glaucoma) have or had seizures or convulsions have low sodium levels in your blood drink alcohol are pregnant or plan to become pregnant.
Taking VIIBYRD late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks to your baby if you take VIIBRYD during pregnancy. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VIIBRYD.
There is a pregnancy registry for females who are exposed to VIIBRYD pregnancy. The purpose of the registry is to collect information about the health of females exposed to VIIBRYD and their baby. If you become pregnant during treatment with VIIBRYD, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants.
You can register by calling 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyreg…