Summary
Alprazolam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Tinnitus would be drug repurposing rather than first-in-human development. This does not mean it is approved for Tinnitus. No registered clinical trial in this database tests Alprazolam specifically in Tinnitus. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 5 publications for this pair: 1 systematic review and 4 clinical trial publications. Publication years run from 1993 to 2021. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Tinnitus ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous resolution in 50-60% of acute tinnitus (<3 months) without treatment; chronic tinnitus (>3 months): only 10-15% spontaneous resolution; habituated tinnitus (not distressing) in 75% at 5 years but sound remains in most.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 31.0 (trials 0.0, literature 11.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 5 (4 clinical trial publications, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRD3 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Alprazolam to Tinnitus in the current OSMF trial extract.
Published literature
- Clinical trial publication Investigating the efficacy of fluoxetine vs. fluoxetine plus alprazolam (single therapy vs. combination therapy) in treatment of chronic tinnitus: A placebo-controlled studySaberi A, Nemati S, Lili EK et al. · American journal of otolaryngology · 2021 · PMID 33476973
- Systematic review The use of benzodiazepines for tinnitus: systematic reviewJufas NE, Wood R · The Journal of laryngology and otology · 2015 · PMID 25858126
- Clinical trial publication Comparison of various treatment modalities for acute tinnitusShim HJ, Song SJ, Choi AY et al. · The Laryngoscope · 2011 · PMID 22109762
- Clinical trial publication The effects of alprazolam on tinnitus: a cross-over randomized clinical trialJalali MM, Kousha A, Naghavi SE et al. · Medical science monitor : international medical journal of experimental and clinical research · 2009 · PMID 19865063
- Clinical trial publication Use of alprazolam for relief of tinnitus. A double-blind studyJohnson RM, Brummett R, Schleuning A · Archives of otolaryngology--head & neck surgery · 1993 · PMID 8343245
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRD3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Alprazolam approved for Tinnitus?
Alprazolam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Tinnitus would be drug repurposing rather than first-in-human development. This does not mean it is approved for Tinnitus. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Alprazolam in clinical trials for Tinnitus?
No registered clinical trial in this database tests Alprazolam specifically in Tinnitus. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Alprazolam in Tinnitus?
Synthesis-level literature links Alprazolam to Tinnitus, but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRD3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.