Summary
Diazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. No registered clinical trial in this database tests Diazepam specifically in Insomnia / Sleep Disorders. 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 10 publications for this pair: 2 Cochrane reviews, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1985 to 2024. 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 Insomnia ranks 317 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: Acute insomnia (<3 months): 50-60% resolve spontaneously; chronic insomnia: only 20-25% spontaneous remission at 1 year; persistent insomnia in 50-75% without treatment.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 50.0 (trials 0.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 10 (5 clinical trial publications, 2 Cochrane reviews, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADCY2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Insomnia / Sleep Disorders in the current OSMF trial extract.
Published literature
- Clinical trial publication Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical TrialFung CH, Alessi C, Martin JL et al. · JAMA internal medicine · 2024 · PMID 39374004
- Clinical trial publication Therapeutic Efficacy of Head Gusha Combined with Kaitianmen in the Management of InsomniaYan L, Jiang L, Liu Y et al. · Alternative therapies in health and medicine · 2024 · PMID 37820682
- Systematic review Melatonin and melatonin agonists as treatments for benzodiazepines and hypnotics withdrawal in patients with primary insomnia. A systematic reviewMorera-Fumero AL, Fernandez-Lopez L, Abreu-Gonzalez P · Drug and alcohol dependence · 2020 · PMID 32409111
- Clinical trial publication [Impacts of the repetitive transcranial acupuncture stimulation on the content of serum orexin A in patients with post-stroke insomnia]Hou Z, Sun Z, Sun S · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2018 · PMID 30672231
- Clinical trial publication [Clinical observation of "Yinqi Guiyuan needles therapy" combined with moxibustion at Yongquan (KI 1) on perimenopausal insomnia with heart-kidney imbalance]Zhang W, Jin Y · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2018 · PMID 30672215
- Meta-analysis Auricular acupuncture for insomnia: a systematic reviewLee MS, Shin BC, Suen LK et al. · International journal of clinical practice · 2008 · PMID 18754807
- Cochrane review Auricular acupuncture treatment for insomnia: a systematic reviewChen HY, Shi Y, Ng CS et al. · Journal of alternative and complementary medicine (New York, N.Y.) · 2007 · PMID 17718650
- Cochrane review Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysisDündar Y, Dodd S, Strobl J et al. · Human psychopharmacology · 2004 · PMID 15252823
- Clinical trial publication Nefazodone in major depression: adjunctive benzodiazepine therapy and tolerabilityRickels K, Schweizer E, Case WG et al. · Journal of clinical psychopharmacology · 1998 · PMID 9580369
- Randomized controlled trial A double-blind group comparative study using the new anti-depressant Org 3770, placebo and diazepam in patients with expected insomnia and anxiety before elective gynaecological surgerySørensen M, Jørgensen J, Viby-Mogensen J et al. · Acta psychiatrica Scandinavica · 1985 · PMID 4003099
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 ADCY2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Diazepam approved for Insomnia / Sleep Disorders?
Diazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Diazepam in clinical trials for Insomnia / Sleep Disorders?
No registered clinical trial in this database tests Diazepam specifically in Insomnia / Sleep Disorders. 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 Insomnia / Sleep Disorders?
Synthesis-level literature links Diazepam to Insomnia / Sleep Disorders, 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 Open Targets and ChEMBL, in this case via the biomarker or target ADCY2. 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 2026-07-05. Page built 2026-10-07.