Summary
Diazepam 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 Diazepam 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 4 publications for this pair: 4 clinical trial publications. Publication years run from 1982 to 1990. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 28.0 (trials 0.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 4 (4 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ANXA4 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Diazepam to Tinnitus in the current OSMF trial extract.
Published literature
- Clinical trial publication Continuous interscalene brachial plexus block during and after shoulder surgeryHaasio J, Tuominen M, Rosenberg PH · Annales chirurgiae et gynaecologiae · 1990 · PMID 2386358
- Clinical trial publication Protracted tinnitus after discontinuation of long-term therapeutic use of benzodiazepinesBusto U, Fornazzari L, Naranjo CA · Journal of clinical psychopharmacology · 1988 · PMID 2903182
- Clinical trial publication Withdrawal reaction after long-term therapeutic use of benzodiazepinesBusto U, Sellers EM, Naranjo CA et al. · The New England journal of medicine · 1986 · PMID 3092053
- Clinical trial publication A modified gas-liquid chromatographic assay to monitor plasma mexiletine in a tinnitus studyPilling M, Tse J, Chan K · Methods and findings in experimental and clinical pharmacology · 1982 · PMID 7121133
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 Open Targets and ChEMBL, in this case via the biomarker or target ANXA4. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Diazepam approved for Tinnitus?
Diazepam 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 Diazepam in clinical trials for Tinnitus?
No registered clinical trial in this database tests Diazepam 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 Diazepam in Tinnitus?
The record for Diazepam in Tinnitus rests on 4 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ANXA4. 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.