did the fda approve trazodone for depression in 1981?
“The FDA approved Trasadone for depression back in 1981.”
a host said on Psychopharmacology and Psychiatry Updates, 2026-09-29, at 01:19. hear it in context →
the episode: Trazodone for Insomnia and Comorbid Depression (at 01:19). we link the show's own page; we do not re-host audio.
first, the part that holds
the host has this right. FDA's own approval database shows trazodone's original application was approved on december 24, 1981, as a new molecular entity, and the FDA label lists depression as the condition it treats.
what we found when we went and looked
we went and looked at FDA's drug approval database (Drugs@FDA) and the openFDA data for the original trazodone application, NDA 018207. Both list the original approval as 12/24/1981 (openFDA date 19811224) and classify it as a "Type 1 - New Molecular Entity". So 1981 was trazodone's first approval for any use in the US. The FDA-archived label for that same application, revised 6/2017, gives "Initial U.S. Approval: 1981" and says the drug is "indicated for the treatment of major depressive disorder (MDD)". The year and the indication both match what the host said.
assertion by assertion
| assertion | verdict | what the record says |
|---|---|---|
| FDA approved trazodone in 1981. | confirmed | Drugs@FDA and openFDA both list the original approval of NDA 018207 (trazodone hydrochloride tablets, 50/100/150/300 mg) on 12/24/1981, as a Type 1 new molecular entity with standard review. This was the first US approval of the molecule. Limit: that date belongs to the original brand-name application. The generic products approved later have their own dates. [1][2] |
| The 1981 approval was for depression. | confirmed | The FDA-archived label for NDA 018207 (revised 6/2017) states 'Initial U.S. Approval: 1981' and 'indicated for the treatment of major depressive disorder (MDD)'. FDA records two efficacy supplements, from 1986 and 1988, and neither adds a new condition. Limit: we did not find the 1981 label itself in the archive. Its exact wording, which may have said 'depression' rather than 'major depressive disorder', could not be read. [2][3] |
both directions
for the speaker: every record we read agrees with the host. Drugs@FDA lists the original approval on 12/24/1981 as a new molecular entity. openFDA gives the same date, 19811224, for the ORIG-1 submission. The FDA-hosted label states 'Initial U.S. Approval: 1981', and its only listed indication is major depressive disorder in adults. The host gave no source, but the FDA's own record says what the host said.
against: nothing in the record contradicts the claim. Some context the claim leaves out: depression is still trazodone's only FDA-approved indication. The FDA records we read show no approval for sleep, so prescribing trazodone for insomnia is off-label use, not something the 1981 approval covers. The original brand-name tablets are now listed as discontinued, though FDA notes this was not for safety or effectiveness reasons. Today's trazodone is supplied as generics approved under separate applications with later dates.
what this cannot say
Drugs@FDA posts label PDFs only from the late 1990s onward, so we could not read the 1981 label. We confirmed the indication from the 2017 label plus the supplement history, not from the original document. The diagnostic term 'major depressive disorder' appeared in DSM-III in 1980, but whether the 1981 label used it is unverified. The FDA records show approval, not how well the drug works or how it compares with other antidepressants. We also did not check approvals outside the US. Trazodone was on the market in Europe before 1981, so '1981' applies only to the US.
sources, each one fetched and read
- US Food and Drug Administration, Drugs@FDA, NDA 018207, trazodone hydrochloride tablets, approval history What we read there: Original approval 12/24/1981, 'Type 1 - New Molecular Entity', standard review priority; all strengths listed as discontinued, 'not discontinued or withdrawn for safety or effectiveness reasons.' Fetched 2026-10-06 (HTTP 200). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018207
- US Food and Drug Administration, openFDA drugsfda endpoint, application NDA018207 What we read there: ORIG-1 approved 19811224 (Type 1 - New Molecular Entity); efficacy supplements 12 (19860902) and 14 (19881107); later labeling supplements through 20250624. Fetched 2026-10-06 (HTTP 200). https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA018207
- US Food and Drug Administration, prescribing information for trazodone hydrochloride tablets, NDA 018207 supplement 032, revised 6/2017 What we read there: 'Initial U.S. Approval: 1981' ... 'indicated for the treatment of major depressive disorder (MDD) (1).' Fetched 2026-10-06 (HTTP 200). https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf
speakers are described by role, not named. one sentence is quoted under fair use, with attribution and a link to the original at the timestamp; we do not re-host audio or video. nothing on this page is a reason to start, stop or change a medication. if you have the file behind anything marked unverifiable, the research board is where people can answer. adam