Triazolam
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Triazolam: From Insomnia to Sleep Disorder (Initiating and Maintaining Sleep)
One-Sentence Summary
Triazolam is a short-acting benzodiazepine hypnotic, originally used to treat insomnia. The TxGNN model predicts it may be effective for sleep disorder, initiating and maintaining sleep, which is closely related to its original indication. Currently 0 clinical trials and 20 publications (mostly reviews and guidelines) are linked to this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Insomnia |
| Predicted New Indication | Sleep disorder, initiating and maintaining sleep |
| TxGNN Prediction Score | 99.72% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid authorizations in the data compiled for this report) |
| Number of NDAs | 3 authorizations in total (1 NDA, 2 ANDAs), all cancelled |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, triazolam is a benzodiazepine-class hypnotic, and its use in insomnia is already established. The literature compiled for this report describes it as a short half-life benzodiazepine hypnotic.
The predicted indication, a sleep disorder of initiating and maintaining sleep, is essentially a different label for insomnia. The high prediction score therefore mainly reflects the overlap with the original indication rather than a genuinely new therapeutic area. This is a re-labelling of the existing use, not a new repurposing opportunity.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
The publications below have not yet been formally classified by study type. The type shown reflects what the titles indicate.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40110890 | 2025 | Systematic review / meta-analysis of RCTs | Psychiatry Clin Neurosci | Efficacy and safety of sleep medication classes (including benzodiazepines) added to antidepressants for depression with insomnia |
| 38401406 | 2024 | Network meta-analysis of RCTs | Eur Neuropsychopharmacol | Residual effects of sleep medications on driving performance |
| 27998379 | 2017 | Clinical practice guideline | J Clin Sleep Med | AASM recommendations on pharmacologic treatment of chronic insomnia in adults |
| 39932761 | 2025 | Review | Minerva Med | Overview of insomnia disorder: prevalence, daytime symptoms and health risks |
| 30058034 | 2018 | Review | Drugs Aging | Pharmacological management recommendations for insomnia in elderly patients |
| 27751669 | 2016 | Review | Clin Ther | Safety and efficacy of sleep medicines in older adults |
| 9161660 | 1997 | Review | Ann Pharmacother | Comparison of zolpidem with triazolam on efficacy and safety |
| 2567741 | 1989 | Critical review | J Clin Psychopharmacol | Rebound insomnia is a distinct possibility after stopping triazolam |
| 8573298 | 1995 | Review | Drug Saf | Assessment of short-acting hypnotics |
| 1319429 | 1992 | Review | J Clin Psychiatry | Pharmacology of benzodiazepine hypnotics, including shorter half-life agents such as triazolam |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA017892 | Triazolam (Aphena Pharma Solutions - Tennessee) | Tablet | Not available; status cancelled |
| ANDA213003 | Triazolam (Zydus Lifesciences) | Tablet | Not available; status cancelled |
| ANDA214219 | Triazolam (PD-Rx Pharmaceuticals) | Tablet | Not available; status cancelled |
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): anxiety disorder, neurotic disorder, dysthymic disorder, kidney disease, liver disease, gallbladder disease, psychotic disorders (including schizophreniform and schizoaffective disorders), mental disorder, sleep apnea syndromes (including obstructive sleep apnea and congenital central hypoventilation syndrome), myasthenia gravis and other neuromuscular junction diseases, and substance-related disorders and substance abuse/dependence.
- Drug Interactions: 100 interactions were found in total; the 20 available for review include:
- Major: morphine (additive central nervous system and respiratory depression is a concern).
- Moderate: bupropion, aprepitant, ranitidine, omeprazole, cimetidine, clarithromycin, miconazole, clotrimazole, dronabinol, nabilone, metoclopramide, eluxadoline, teduglutide.
- Minor: dexamethasone, betamethasone, prednisone, magnesium oxide, aluminum hydroxide, calcium carbonate.
- Literature-noted concerns: rebound insomnia after discontinuation, residual effects on driving, and abuse/dependence risk.
Please refer to the package insert for key warnings and formal contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The predicted indication is essentially the same as the original one (insomnia), so it adds no real repurposing value. There are no registered clinical trials, the literature is mostly general reviews and guidelines, and all three US authorizations are cancelled. Safety data from the package insert are also missing.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Confirmation of whether the predicted indication differs meaningfully from the existing insomnia indication
- Classification and relevance screening of the retrieved literature
- Clarification of why all US authorizations are cancelled, and of current marketing status
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.