Chlordiazepoxide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Chlordiazepoxide: Insomnia (disease)
One-Sentence Summary
Chlordiazepoxide is a benzodiazepine originally used for anxiety, alcohol withdrawal and several related conditions. The TxGNN model predicts it may be effective for insomnia, but there are no registered clinical trials and the 5 publications retrieved are mostly class-level reviews or anxiety-focused studies, so the evidence is indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled data. Chlordiazepoxide is a benzodiazepine, a class that enhances GABA-A receptor signalling and produces sedative-hypnotic effects. This is a plausible mechanism for insomnia.
Anxiety and insomnia commonly occur together, and benzodiazepine hypnotics are an established class for sleep problems. However, the evidence here is indirect: class-level reviews and anxiety-focused studies. No chlordiazepoxide-specific insomnia trial was found. Its long half-life and active metabolites, together with safety concerns in older adults (Beers-type potentially inappropriate medication), limit its suitability.
A related prediction, sleep disorder (initiating and maintaining sleep), has more literature, including a double-blind comparison of chlordiazepoxide-amitriptyline (Limbitrol) with amitriptyline on sleep efficiency and architecture. It is a combination product, so it does not isolate chlordiazepoxide.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Pharmacokinetics of anxiolytic drugs; anxiolytics are among the most prescribed psychoactive drugs |
| 2883822 | 1986 | Review | Acta Psychiatr Scand Suppl | Benzodiazepine hypnotics in the elderly; response to benzodiazepines is increased with ageing |
| 30680986 | 2019 | Cross-sectional study | Med Glas | Prevalence of potentially inappropriate medications among Iranian older adults |
| 4628683 | 1972 | Clinical trial | Curr Ther Res Clin Exp | Molindone vs chlordiazepoxide in anxious outpatients |
| 14085195 | 1963 | Clinical study | Acta Psychiatr Scand | Treatment of anxiety neuroses with a Librium metabolite, Ro 4-5360 |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 00522996 | CHLORDIAZEPOXIDE | Not specified | Not specified |
| 00115630 | LIBRAX | Not specified | Not specified |
Safety Considerations
- Contraindications flagged in the knowledge graph (not from label text): hypertension, orthostatic hypotension, long QT syndrome and torsades de pointes, epilepsy, gastric ulcer, kidney disease, liver disease, porphyria, hypothyroidism, open-angle glaucoma, systemic lupus erythematosus, psychotic disorders, and manic bipolar disorder, among others.
- Drug interactions: 100 interactions were found in total. The main Major ones are with morphine and liposomal morphine (additive central nervous system and respiratory depression). Moderate ones include bupropion, omeprazole, cimetidine, clarithromycin, dronabinol, nabilone, metoclopramide, opium, sibutramine and teduglutide. Antacids such as aluminium hydroxide, calcium carbonate and magnesium salts are Minor.
- Class-level concerns noted in the literature: dependence, next-day sedation, and falls in older adults.
Please also refer to the package insert, as label warnings were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is supported only by indirect, class-level literature. There are no clinical trials and no chlordiazepoxide-specific insomnia study. Safety concerns (dependence, sedation, age-related risk, and a long list of knowledge-graph contraindications) further limit its suitability against established alternatives.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications
- Mechanism of action data
- Direct evidence of chlordiazepoxide for insomnia (for example, a randomized trial or a systematic review against other benzodiazepine hypnotics)
- A risk-benefit assessment for older adults and for long-term use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.