Alprazolam
| Evidence Level: L3 | Predicted Indications: 2 |
Table of Contents
Alprazolam: 失眠 (insomnia (disease))
One-Sentence Summary
Alprazolam is a benzodiazepine that enhances GABA-A receptor signalling. The TxGNN model predicts it may be useful for insomnia, with a prediction score of 0.9981. Evidence is at L3: no clinical trials are registered, and the supporting literature is limited to observational work, including a retrospective study in which alprazolam was used for patients with coronary heart disease and insomnia.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | 失眠 (insomnia (disease)) |
| TxGNN Prediction Score | 0.9981 |
| Evidence Level | L3 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Based on known class pharmacology, alprazolam is a benzodiazepine that enhances GABA-A receptor signalling, which produces sedative and hypnotic effects.
This gives a plausible mechanistic link to insomnia, particularly insomnia that co-occurs with anxiety. This link rests on general class pharmacology rather than on data supplied for this report.
Benzodiazepines are generally limited to short-term use for insomnia because of tolerance, dependence, next-day impairment and fall risk. These limits weigh heavily on any repurposing decision.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
No randomised controlled trial of alprazolam in insomnia is included. The most relevant item is a retrospective observational study; the remaining items are reviews, cross-sectional or indirect studies.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39183410 | 2024 | Retrospective observational study | Medicine | 116 patients with coronary heart disease and insomnia; the control group received alprazolam and the experimental group received Du Meridian moxibustion and ear acupuncture on top of it. Effects on cardiac function and neurotransmitter levels were assessed. Alprazolam was not the isolated intervention. |
| 38363887 | 2024 | Cross-sectional | Medicine | Survey of insomnia among COVID-19 survivors; describes occurrence and influencing factors, not alprazolam treatment. |
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Pharmacokinetics of anxiolytic drugs; background only. |
| 36692463 | 2023 | Meta-analysis | Acta Pharm | Tranquilisers in elderly patients with chronic non-communicable diseases; assesses dose, outcomes and adverse effects. |
| 37984023 | 2024 | Predictive model / economic analysis | Value Health Reg Issues | Benzodiazepines are widely prescribed for anxiety and insomnia; long-term use is linked to memory loss, dependence, falls and traffic accidents. |
| 15341891 | 2004 | Prescribing pattern study | Sleep Med | Characteristics of hypnotic prescriptions for insomnia in a managed-care population. |
| 37801512 | 2023 | Preclinical (mouse) | Aging | Repeated alprazolam administration caused mitochondrial dysfunction and impaired hippocampus-dependent memory consolidation in mice. |
| 35493764 | 2022 | Cohort (indirect) | JHEP Rep | Zolpidem deprescribing reduced falls and fractures in patients with cirrhosis; indirect relevance. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 11186R | Alprax 1 | Tablet 1 mg | Not recorded in the local data |
Safety Considerations
- Drug Interactions: 100 interactions were found in the interaction query. Examples include:
- Major: morphine (including liposomal morphine)
- Moderate: aprepitant, bupropion, cimetidine, clarithromycin, clotrimazole, dronabinol, eliglustat, glycerol phenylbutyrate, metoclopramide, miconazole
- Minor: aluminium hydroxide, calcium carbonate, magnesium-containing antacids, betamethasone, dexamethasone
For warnings and contraindications, please refer to the TGA-approved Product Information (PI) for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence level is L3. The only directly relevant study is a retrospective observational study in which alprazolam was part of the treatment for insomnia in coronary heart disease patients, and there are no registered trials or randomised data. Known benzodiazepine risks (tolerance, dependence, next-day impairment, falls) and a major interaction with opioids further limit the case for repurposing.
To proceed, the following is needed:
- Randomised controlled trial evidence of alprazolam specifically for insomnia
- Detailed mechanism of action data
- Safety information from the TGA-approved Product Information, including warnings and contraindications
- A plan for short-term use limits and monitoring in higher-risk groups (older adults, patients taking opioids)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.