Triazolam
| 證據等級: L5 | 預測適應症: 2 個 |
目錄
- Triazolam
- Triazolam: From Insomnia (Established Use) to Sleep Disorder, Initiating and Maintaining Sleep
Triazolam: From Insomnia (Established Use) to Sleep Disorder, Initiating and Maintaining Sleep
One-Sentence Summary
Triazolam is a short-acting benzodiazepine; the evidence pack does not document its original approved indication, but it is widely known as a short-term hypnotic for insomnia. The TxGNN model predicts high applicability for Sleep Disorder, Initiating and Maintaining Sleep — a disease label that is essentially synonymous with insomnia. This is supported by 0 clinical trials and 20 publications, and the overlap with the drug’s known use should be treated as a caveat rather than a novel repurposing signal.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in evidence pack (data gap); generally known as a short-term insomnia hypnotic |
| Predicted New Indication | Sleep Disorder, Initiating and Maintaining Sleep |
| TxGNN Prediction Score | 99.72% |
| Evidence Level | L3 |
| Denmark Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in this evidence pack. Based on general pharmacological knowledge (not sourced from the pack itself), Triazolam is a short-acting benzodiazepine that acts as a positive allosteric modulator at the GABA-A receptor, and is conventionally used for the short-term treatment of insomnia.
The predicted new indication — “Sleep disorder, initiating and maintaining sleep” — describes the same clinical entity as insomnia. This means the TxGNN model’s very high score (99.72%) most likely reflects the drug’s already-established pharmacological role rather than a genuinely novel repurposing opportunity. Several of the retrieved publications directly discuss triazolam’s known use and comparative pharmacology among hypnotics (e.g., versus zolpidem), reinforcing that this is a recovered known association rather than new evidence of an off-label use.
Because the evidence pack itself contains no formally recorded “original indication” and flags mechanism-of-action as a data gap, this association should be independently confirmed against an authoritative source (e.g., SmPC) before treating it as an actionable repurposing signal.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 33249496 | 2021 | Systematic Review / Network Meta-analysis | Sleep | Comparative efficacy and safety of hypnotics, including triazolam, for insomnia in older adults |
| 40110890 | 2025 | Systematic Review / Meta-analysis (RCTs) | Psychiatry and Clinical Neurosciences | Efficacy/safety of sleep medication classes (incl. benzodiazepines) combined with antidepressants for MDD with insomnia |
| 27998379 | 2017 | Clinical Practice Guideline | Journal of Clinical Sleep Medicine | AASM guideline on pharmacologic treatment of chronic insomnia in adults |
| 19682231 | 2010 | Original Study | Journal of Sleep Research | Retrograde effects of triazolam and zolpidem on sleep-dependent motor learning |
| 2567741 | 1989 | Review | Journal of Clinical Psychopharmacology | Critical review of rebound insomnia after discontinuation of triazolam and other short half-life benzodiazepines |
| 1319429 | 1992 | Review | The Journal of Clinical Psychiatry | Pharmacology of benzodiazepine hypnotics, including triazolam’s historical role |
| 9161660 | 1997 | Review | The Annals of Pharmacotherapy | Comparative efficacy/safety review: zolpidem versus triazolam |
| 3332464 | 1987 | Review | Seminars in Neurology | Clinical neuropharmacology of sleep disorders, including benzodiazepine hypnotics |
| 30058034 | 2018 | Review | Drugs & Aging | Recommendations for pharmacological management of insomnia in elderly patients |
| 27751669 | 2016 | Review | Clinical Therapeutics | Safety and efficacy review of sleep medicines in older adults |
Denmark Market Information
Triazolam currently holds no marketing authorisation in Denmark (market status: Not marketed; 0 registered licenses).
Safety Considerations
Please refer to the approved Summary of Product Characteristics (SmPC) for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The predicted indication overlaps with triazolam’s already-established pharmacological role as an insomnia hypnotic, so this does not represent a clearly novel repurposing signal; combined with no clinical trials, no Danish marketing authorisation, and a blocking data gap on SmPC warnings/contraindications, the case is not yet ready to advance.
To proceed, the following is needed:
- Confirmation of triazolam’s formally documented original indication and MOA (currently data gaps in this pack)
- TFDA/SmPC warnings and contraindications (blocking data gap, DG001)
- Clarification of whether this candidate represents a genuinely new indication versus a restatement of the drug’s known use, before further clinical evaluation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.