Alprazolam
| Evidence Level: L3 | Predicted Indications: 2 |
Table of Contents
Alprazolam: Insomnia (disease)
One-Sentence Summary
Alprazolam is a benzodiazepine that enhances GABA-A receptor signaling and produces sedative and anxiolytic effects. The TxGNN model predicts it may be effective for insomnia, but the evidence is thin: no registered clinical trials and only one retrospective observational study that directly involves alprazolam in patients with insomnia (Evidence Level L3).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 0.9981 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, alprazolam is a benzodiazepine that enhances GABA-A receptor signaling, which produces sedative and anxiolytic effects.
Sedation is a plausible link to insomnia, particularly insomnia that occurs together with anxiety. A calming effect on an over-aroused nervous system could, in principle, help patients fall asleep.
However, this reasoning is a mechanistic inference. The very high TxGNN score is a computational prediction and does not replace clinical evidence. Benzodiazepine risks (dependence, falls, cognitive impairment) also weigh against repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
The retrieved publications are mostly indirect. The only study that directly involves alprazolam in patients with insomnia is a retrospective observational study, and no randomized controlled trial of alprazolam for insomnia was found.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39183410 | 2024 | Retrospective observational study | Medicine | 116 patients with coronary heart disease and insomnia; alprazolam control group compared with Du Meridian moxibustion plus ear acupuncture, assessing symptoms, cardiac function and neurotransmitter levels |
| 38363887 | 2024 | Cross-sectional | Medicine | Survey of insomnia and its influencing factors among COVID-19 survivors; not a drug study |
| 36692463 | 2023 | Meta-analysis | Acta Pharmaceutica | Tranquilizer use in elderly patients with chronic diseases: doses, outcomes and adverse effects |
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Pharmacokinetics of anxiolytic drugs |
| 37984023 | 2024 | Predictive modelling | Value in Health Regional Issues | Benzodiazepine use trends and economic burden; long-term use linked to memory loss, dependence and falls |
| 15341891 | 2004 | Prescription pattern study | Sleep Medicine | Characteristics of hypnotic prescriptions for insomnia in a managed-care population |
| 37801512 | 2023 | Preclinical (mouse) | Aging | Repeated alprazolam administration linked to mitochondrial dysfunction and impaired memory consolidation |
India Market Information
Alprazolam is marketed in India, with 20 valid single-ingredient licences in the data compiled for this report (the list may be partial). The licence records carry no approved-indication text. Main licences:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 83548 | Eurolam 1mg Tablet SR | Strip of 10 SR tablets | Not recorded |
| 176351 | Prazolam 0.25mg Tablet | Strip of 10 tablets | Not recorded |
| 7607 | Alpaz 0.25mg Tablet | Strip of 10 tablets | Not recorded |
| 14252 | Aenzo 0.25mg Tablet | Strip of 10 tablets | Not recorded |
| 181366 | Procalm 1mg Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
- Drug Interactions: 273 interactions are recorded. The most serious are Major interactions with morphine and liposomal morphine. Moderate interactions include aprepitant, bupropion, cimetidine, clarithromycin, clotrimazole, dronabinol, eliglustat, metoclopramide and miconazole. Antacids (aluminum hydroxide, magnesium salts, calcium carbonate) and some corticosteroids (betamethasone, dexamethasone) are Minor.
- Class risks: Published literature on benzodiazepines points to dependence, falls, cognitive impairment and memory problems with long-term use.
- Conditions of concern: Recorded contraindication relations include kidney disease, liver disease, gallbladder disease, glaucoma (open-angle and angle-closure), obesity, sleep apnea and other breathing-related sleep disorders, and substance-related disorders. These are not taken from label text, so please refer to the package insert for authoritative information.
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score is very high (0.9981), but the supporting evidence is a single retrospective observational study in a special population (coronary heart disease with insomnia), with no registered trials and no randomized controlled trial in insomnia. Known benzodiazepine risks and the large number of drug interactions further argue for caution.
To proceed, the following is needed:
- A randomized controlled trial of alprazolam for insomnia, ideally comparing it with established hypnotics
- Detailed mechanism of action data
- Package insert warnings and contraindications from the India licence holders
- A risk-benefit assessment of dependence, falls, cognitive effects and respiratory risk, especially in older adults and patients with sleep apnea
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.