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Vilazodone

Ziladone · ATC code N06AX24

Also known as: Vilazodon

Key facts
Active substance
Vilazodone
Drug class
Antidepressant
ATC code
N06AX24
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Antidepressants increased the risk of suicidal thoughts and behaviors 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)] . Vilazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)].

Key facts

Vilazodone is, per the US prescribing information, a serotonergic antidepressant used to treat major depressive disorder (MDD) in adults.

What it is used for

  • Treatment of major depressive disorder in adults.
  • Not approved for use in pediatric patients.

Dosing

  • Target dose 20 mg to 40 mg once daily with food.
  • Titration: 10 mg once daily for 7 days, then 20 mg once daily; may be increased to 40 mg once daily after at least 7 days.
  • Strong CYP3A4 inhibitors (e.g. itraconazole, clarithromycin, voriconazole): no more than 20 mg once daily; strong CYP3A4 inducers for more than 14 days: consider up to a 2-fold increase, maximum 80 mg once daily.
  • Taper when stopping: from 40 mg to 20 mg once daily for 4 days, then 10 mg once daily for 3 days.
  • No dose adjustment for age or renal or hepatic impairment; screen for bipolar disorder before starting.

Contraindications

  • Taking MAOIs (including linezolid or intravenous methylene blue) or within 14 days of stopping them.

Important warnings

  • Boxed warning: antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies; monitor all patients for clinical worsening.
  • Serotonin syndrome, particularly with other serotonergic drugs.
  • Increased risk of bleeding, especially with aspirin, NSAIDs, antiplatelet drugs or warfarin.
  • Activation of mania/hypomania; discontinuation syndrome after abrupt stopping; seizures; angle-closure glaucoma.
  • Hyponatremia (especially in elderly patients and with diuretics); sexual dysfunction.

Side effects

  • Most common: diarrhea, nausea, vomiting and insomnia.
  • In trials included: diarrhea 26% and 29% (20 mg and 40 mg) vs. 10% with placebo, nausea 22% and 24% vs. 7%, insomnia 7% and 6%.
  • Postmarketing: irritability, sleep paralysis, hallucinations, rash, acute pancreatitis.

Interactions

  • MAOIs: contraindicated (serotonin syndrome).
  • Other serotonergic drugs (e.g. triptans, tricyclic antidepressants, fentanyl, lithium, tramadol): risk of serotonin syndrome.
  • Aspirin, NSAIDs and anticoagulants: increased bleeding risk; monitor coagulation indices with warfarin.
  • Strong CYP3A4 inhibitors or inducers: dose adjustment needed.

Pregnancy and breastfeeding

  • SSRI exposure, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage; there are no adequate studies of vilazodone.
  • No data on presence in human milk; vilazodone is excreted in rat milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Turkey

  • ZiladoneNOBEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • ViibrydAllergan, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. U.S. Food and Drug Administration. Vilazodone Hydrochloride (Accord Healthcare Inc.) – Prescribing Information, 2025-10-08. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f917f30d-f2a7-43eb-836f-53eaa2a31cb0
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  4. Wikidata (CC0): ATC N06AX.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.