Summary
Triazolam 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. ClinicalTrials.gov lists 1 registered trial linking Triazolam to Insomnia / Sleep Disorders: 1 has completed. The most advanced is Phase 3 (NCT01888497). It plans or enrolled 59 participants. Registered activity dates to 2013. The literature layer holds 13 publications for this pair: 3 Cochrane reviews, 4 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 1999 to 2025. 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 | 54.5 (trials 4.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 13 (5 clinical trial publications, 4 meta-analyses, 3 Cochrane reviews, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01888497 | Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers 2013 | completed | Phase 3 | 59 |
Published literature
- Meta-analysis Efficacy and safety of each class of sleep medication for major depressive disorder with insomnia symptoms: A systematic review and meta-analysis of double-blind randomized controlled trialsMaruki T, Takeshima M, Yoshizawa K et al. · Psychiatry and clinical neurosciences · 2025 · PMID 40110890
- Meta-analysis Residual effects of medications for sleep disorders on driving performance: A systematic review and network meta-analysis of randomized controlled trials: NMA driving and hypnoticsFornaro M, Caiazza C, Rossano F et al. · European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2024 · PMID 38401406
- Meta-analysis Comparative efficacy and safety of hypnotics for insomnia in older adults: a systematic review and network meta-analysisChiu HY, Lee HC, Liu JW et al. · Sleep · 2021 · PMID 33249496
- Cochrane review Pharmacological interventions for the treatment of insomnia: quantitative comparison of drug efficacyZheng X, He Y, Yin F et al. · Sleep medicine · 2020 · PMID 32544795
- Cochrane review Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviewsRios P, Cardoso R, Morra D et al. · Systematic reviews · 2019 · PMID 31730011
- Clinical trial publication Effects of different doses of triazolam in the middle-of-the-night insomnia: a double-blind, randomized, parallel group studyFerini Strambi L, Marelli S, Zucconi M et al. · Journal of neurology · 2017 · PMID 28584913
- Systematic review Pharmacological treatment of insomnia in alcohol recovery: a systematic reviewKolla BP, Mansukhani MP, Schneekloth T · Alcohol and alcoholism (Oxford, Oxfordshire) · 2011 · PMID 21715413
- Cochrane review Insomnia in the elderlyMontgomery P, Lilly J · BMJ clinical evidence · 2007 · PMID 19450355
- Clinical trial publication CAP variables and arousals as sleep electroencephalogram markers for primary insomniaTerzano MG, Parrino L, Spaggiari MC et al. · Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2003 · PMID 12948801
- Clinical trial publication Nighttime versus daytime hypnotic self-administrationRoehrs T, Bonahoom A, Pedrosi B et al. · Psychopharmacology · 2002 · PMID 11981593
- Clinical trial publication A double-blind, randomized and placebo-controlled study on the polysomnographic withdrawal effects of zopiclone, zolpidem and triazolam in healthy subjectsVoderholzer U, Riemann D, Hornyak M et al. · European archives of psychiatry and clinical neuroscience · 2001 · PMID 11697572
- Clinical trial publication Treatment regimen and hypnotic self-administrationRoehrs T, Bonahoom A, Pedrosi B et al. · Psychopharmacology · 2001 · PMID 11374329
- Meta-analysis Tolerance and rebound insomnia with rapidly eliminated hypnotics: a meta-analysis of sleep laboratory studiesSoldatos CR, Dikeos DG, Whitehead A · International clinical psychopharmacology · 1999 · PMID 10529072
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. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Triazolam approved for Insomnia / Sleep Disorders?
Triazolam 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 Triazolam in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 1 registered trial linking Triazolam to Insomnia / Sleep Disorders: 1 has completed. The most advanced is Phase 3 (NCT01888497). It plans or enrolled 59 participants. Registered activity dates to 2013.
What does the evidence show for Triazolam in Insomnia / Sleep Disorders?
Triazolam has both completed registered trials and synthesis-level publications linked to Insomnia / Sleep Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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. 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.