Etizolam
| Evidence Level: L4 | Predicted Indications: 1 |
Table of Contents
Etizolam: From Anxiety to Insomnia
One-Sentence Summary
Etizolam is a thienodiazepine originally used to treat anxiety. The TxGNN model predicts it may be effective for insomnia, but the supporting evidence is thin: 0 registered clinical trials and 4 publications, only one of which (a rat study) directly addresses etizolam’s effect on sleep.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Anxiety |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 0.9994 |
| Evidence Level | L4 |
| 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 drug class knowledge, etizolam is a thienodiazepine that acts as a positive allosteric modulator of the GABA-A receptor. This is the same mechanism shared by benzodiazepine hypnotics, which gives a plausible pharmacological basis for sedative and sleep-promoting effects. This link is inferred from class knowledge, not from the supplied data.
Anxiety and insomnia often occur together, and both respond to drugs that enhance GABAergic inhibition. A preclinical rat study found that etizolam shortened sleep latency, increased non-REM sleep time, and decreased wake time in a dose-dependent manner, which is consistent with the prediction.
The very high TxGNN score (0.9994) is a computational prediction only and is not clinical evidence. No human trial data for insomnia are included in the data compiled for this report.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 18789918 | 2008 | Preclinical (animal study) | Eur J Pharmacol | In rats, etizolam and triazolam shortened sleep latency, increased non-REM sleep and decreased wake time. Abrupt withdrawal after 7 days caused rebound insomnia (prolonged sleep latency). |
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Review of the pharmacokinetics of anxiolytic drugs; anxiety disorders are common and anxiolytics are widely prescribed. Indirect relevance to insomnia. |
| 23553148 | 2013 | Case report | J Anesth | Postoperative neuroleptic malignant syndrome-like symptoms after withdrawal of oral etizolam; improved with intravenous diazepam. Not directly relevant to insomnia efficacy. |
| 29105206 | 2018 | Cohort/Observational | J Paediatr Child Health | Risk factors for psychological and psychosomatic symptoms in children with malignancies. Unrelated population. |
India Market Information
Etizolam has 20 valid single-ingredient registrations in India and none cancelled. The approved indication text is not available for these products. Five representative registrations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 72556 | Etirest 0.5 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not specified |
| 72371 | Etizola Beta 0.5 Tablet (Macleods Pharmaceuticals Pvt Ltd) | Strip of 10 tablets | Not specified |
| 250188 | Zolamed 0.5mg Tablet (Medirin Pharmaceuticals Pvt Ltd) | Strip of 10 tablets | Not specified |
| 247939 | Zolavil 0.5mg Tablet MD (Viltis Pharma Private Limited) | Strip of 10 tablets MD | Not specified |
| 109969 | Inxity 0.5mg Tablet (Archicare Limited) | Strip of 10 tablets | Not specified |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a computational score and a plausible class-based mechanism, supported only by one preclinical rat study. There are no registered clinical trials or human efficacy data for insomnia, and safety information is missing from the data compiled for this report.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulatory source (a blocking gap for safety screening)
- Mechanism of action data from DrugBank to confirm the mechanistic link
- Human clinical evidence for etizolam in insomnia (trials or systematic reviews)
- Assessment of dependence, withdrawal and rebound insomnia risk, given the rebound insomnia seen in the animal study and the withdrawal-related case report
- Approved indication text for the Indian registrations, to check whether sleep-related uses are already labelled
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.