vortioxetine (Trintellix)

How long the trials actually ran

The longest trial behind the vortioxetine approval ran 8 weeks.

The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.

How many Americans take vortioxetine

Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.

1,826,351

prescriptions in the United States (2020)

341,417

people filling them (2020)

Prescriptions are up 6% since 2016. Whatever you decide about vortioxetine, you are deciding alongside about 341,417 other people this year.

Source: ClinCalc DrugStats (Medical Expenditure Panel Survey (MEPS), Agency for Healthcare Research and Quality), CC BY-SA 4.0, release 2026.08.

What people report to the FDA about vortioxetine

16,915

reports mentioning vortioxetine, all time

8,091

filed as serious (a report-level flag covering every drug and outcome in the report)

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, data through 2026-07-30.

Known interactions, from the label

The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.

FDA label for vortioxetine, effective April 23, 2026 — DailyMed.

Who pays for vortioxetine

Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.

Medicare Part D

100,662 beneficiaries filled 609,743 claims in 2024 — 61,289 aged 65 and over, and 39,373 under 65. The under-65 group is not a picture of ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error.

Medicaid

At least 386,748 prescriptions in 2024 — a floor, because 0 of 24 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.

All payers (survey estimate)

The MEPS-based estimate above puts the whole country at 1,826,351 prescriptions and 341,417 people in 2020. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.

The population nobody counts

The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of vortioxetine specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.

Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.

The approval, step by step

1. Step 1

   What the approval was actually based on

   Which studies did the FDA rely on, how long did they run, and who was in them?

   The efficacy of TRINTELLIX in treatment for MDD was established in six, 6 to 8 week randomized, double-blind, placebo-controlled, fixed-dose studies (including one study in the elderly) and one maintenance study in adult inpatients and outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD.

   FDA-approved labelling, 14 CLINICAL STUDIES — read the label on DailyMed

   Our reading

   Six acute trials of six to eight weeks plus a maintenance study — a package on the larger side for a modern antidepressant, including a dedicated elderly study, which is rarer than it should be. Vortioxetine is one of the newest antidepressants in this directory and among the most expensive, marketed on a multimodal mechanism; the label establishes that it beats placebo on depression scores, and the premium-price question — better than the generics? — is not one an approval package is required to answer, and this one does not.

2. Step 2

   The approval

   When was it approved, under what application, and by whose review?

   Approved

   September 30, 2013

   Application

   NDA204447

   Review

   STANDARD

   Original sponsor

   Takeda and Lundbeck

   Holds it now

   Takeda Pharmaceuticals USA

   Label submissions since

   21

   Source: openFDA Drugs@FDA, original application ORIG-1

3. Step 3

   What was added after it was on the market

   Which warnings arrived only after millions of people were already taking it?

   • The antidepressant suicidality warning has an age ceiling most people never hear about

     Antidepressants carry a boxed warning about suicidal thoughts and behaviour in children, adolescents and young adults. It came from pooling 24 short-term placebo-controlled trials of nine antidepressants in more than 4,400 young patients: suicidality was reported in about 4% on drug against 2% on placebo. There were no completed suicides in those trials.

     The part that usually gets lost is the age boundary, which is in the label itself. The studies did not show an increased risk above age 24, and in patients 65 and older the risk went in the other direction — it was reduced. The warning is real and it is specific, not a blanket statement about everyone who takes one.

     Worth asking

     Given my age, which side of that line am I on, what specifically should I or the people around me watch for in the first two months, and who do I call if it happens.

     PROZAC (fluoxetine) prescribing information — Boxed Warning: Suicidal Thoughts and Behaviors — U.S. Food and Drug Administration (approved labelling)

4. Step 4

   What independent research has found since

   What has been learned by people who were not selling it?

   • Withdrawal from these medications can take months, and NICE says so

     9 years after approval

     NICE guideline NG215 covers safe prescribing and managed withdrawal for five groups of medication: opioids, benzodiazepines, gabapentinoids, Z-drugs and antidepressants. It is the closest thing there is to an official answer on how coming off actually goes.

     It states that withdrawal can be difficult and may take several months or more, that symptoms vary widely in type and severity, that they affect both physical and mental health, and that they can be delayed in onset and can persist. Two recommendations are worth quoting to a prescriber. Do not stop a medicine abruptly except in exceptional medical circumstances. And taper using a slow, stepwise reduction proportionate to the current dose, so the decrements get smaller as the dose gets lower — not a fixed cut each time.

     That last detail is the one most commonly missed. Gabapentinoids are the exception in the guideline and are reduced by a fixed amount at each step.

     Worth asking

     Can we write the taper down, what size are the steps near the end, and how long do I hold at each step before the next reduction.

     Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults (NG215) — National Institute for Health and Care Excellence (2022)

   • In 2019 the Royal College of Psychiatrists changed its position on withdrawal

     6 years after approval

     For years people reporting long, severe antidepressant withdrawal were told it lasted a week or two. In May 2019 the Royal College of Psychiatrists published a position statement conceding the point: while withdrawal symptoms are often mild and self-limiting, there is substantial variation, and for some patients symptoms last much longer and are more severe.

     It went further and asked for changes — that guidelines and patient information recognise the potential for severe and long-lasting withdrawal, that pharmacologically-informed tapering guidance be developed, that discontinuation be tapered at a rate the patient can tolerate over potentially several months, and that clinicians actively work to tell withdrawal apart from relapse.

     One thing it explicitly does not say, and it is worth being accurate about: the College states that from a clinical perspective antidepressant use is not associated with dependence in the addiction sense. Withdrawal and dependence are not the same claim.

     Worth asking

     If I feel bad three weeks after a dose reduction, how will we decide whether that is withdrawal or my depression returning, and what do we do differently in each case.

     Position statement on antidepressants and depression (PS04/19) — Royal College of Psychiatrists (2019)

5. Step 5

   What still is not known

   Which questions you might reasonably have has nobody answered yet?

   • The approval shows superiority to placebo. The price assumes superiority to sertraline. Where is that comparison?
   • A claimed cognition benefit was reviewed by FDA in 2018 — read what the label actually says about it versus what the marketing implies.
   • Six-to-eight-week trials, maintenance study aside — the long-term question stands here as everywhere.