Chlordiazepoxide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Chlordiazepoxide: From Anxiety and Alcohol Withdrawal to Insomnia
One-Sentence Summary
Chlordiazepoxide is a benzodiazepine originally used for anxiety, alcohol withdrawal, and related conditions. The TxGNN model predicts it may be effective for insomnia, but there are no registered clinical trials and only 5 publications, mostly general reviews, supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Anxiety, alcohol withdrawal, peptic ulcer disease, irritable bowel syndrome and others (the India licences list no approved indication text) |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L5 |
| 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?
Currently, detailed mechanism of action data is not available. Based on known information, chlordiazepoxide is a benzodiazepine that enhances GABA-A receptor signalling. Its efficacy in anxiety and alcohol withdrawal is long established, and mechanistically it may be applicable to sleep problems.
Sedation from GABA-A modulation can plausibly shorten the time to fall asleep, which links the original anxiolytic use to insomnia. However, chlordiazepoxide is not approved as a hypnotic. It is long-acting with active metabolites, so it can accumulate and cause next-day sedation, particularly in older adults. The retrieved literature is mostly general benzodiazepine reviews, pharmacokinetics, and older anxiety studies, not insomnia-specific trials of chlordiazepoxide.
Other predictions on the list (such as cauda equina syndrome, obsolete neurogenic bladder, ADHD inattentive type, and myofascial pain syndrome) have no supporting evidence. The related prediction “sleep disorder, initiating and maintaining sleep” has only indirect evidence, and none of it is specific to 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 2-3 fold with ageing |
| 30680986 | 2019 | Cross-sectional | Med Glas | Prevalence of potentially inappropriate medications among Iranian older adults (Beers criteria) |
| 4628683 | 1972 | Clinical trial | Curr Ther Res | Molindone versus chlordiazepoxide in anxious outpatients |
| 14085195 | 1963 | Clinical study | Acta Psychiatr Scand | Anxiety neuroses and psychosomatic syndromes treated with a Librium metabolite |
Indirect evidence from the related prediction “sleep disorder, initiating and maintaining sleep”:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3536890 | 1986 | Double-blind randomized study | J Clin Psychiatry | Chlordiazepoxide-amitriptyline (Limbitrol) vs amitriptyline: faster symptom improvement with Limbitrol, no differences in sleep laboratory parameters |
| 7595266 | 1995 | Review | J Fam Pract | Benzodiazepines for insomnia in community-dwelling elderly: no long-term effectiveness studies; injury risk reviewed |
| 22521806 | 2013 | Review | Eur Psychiatry | Critical reappraisal of the role of benzodiazepines in psychiatric disorders |
| 6137426 | 1983 | Randomized double-blind trial | J Int Med Res | Clobazam vs chlordiazepoxide in acute alcohol withdrawal; both effective |
| 4365779 | 1974 | Comparative study | Br J Psychiatry | Hypnotic effects of chlordiazepoxide vs amylobarbitone sodium |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 48889 | Cinipox 5mg/2.5mg Tablet | Strip of 10 tablets | Not specified |
| 74519 | Ebrium 10mg Tablet | Strip of 10 tablets | Not specified |
| 72340 | Equirex Tablet | Strip of 10 tablets | Not specified |
| 47480 | Cdprex 10mg Tablet | Strip of 10 tablets | Not specified |
| 204193 | Sledge 5mg/2.5mg Tablet | Strip of 10 tablets | Not specified |
In total, 20 valid single-ingredient oral tablet registrations were found; the five above are shown as examples.
Safety Considerations
- Contraindications (from the knowledge graph, not label text): the knowledge graph lists the following conditions: hypertension, orthostatic hypotension, long QT syndrome and torsades de pointes, epilepsy, gastric ulcer, porphyria, kidney disease, liver disease, gallbladder disease, hypothyroidism, open-angle glaucoma, systemic lupus erythematosus, psychotic disorders, and manic bipolar disorder. These should be verified against the official package insert.
- Drug Interactions: 104 interactions were found. Major interactions include morphine and liposomal morphine (additive central nervous system and respiratory depression). Moderate interactions include bupropion, omeprazole, cimetidine, clarithromycin, dronabinol, metoclopramide, nabilone, opium, sibutramine, and teduglutide. Minor interactions include antacids such as aluminium hydroxide, calcium carbonate, and magnesium salts.
- Class risks noted in the literature: dependence, tolerance, falls, cognitive impairment, and next-day sedation, especially in older adults.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but no clinical trials exist and the literature offers no chlordiazepoxide-specific insomnia efficacy data. The drug is long-acting with active metabolites, and safer, established hypnotics are available, so the benefit-risk balance is unproven.
To proceed, the following is needed:
- Detailed mechanism of action data (MOA)
- Package insert warnings and contraindications from the India regulatory source (currently missing, which blocks safety screening)
- Insomnia-specific controlled trials of chlordiazepoxide, or a comparison with approved hypnotics
- A safety plan for older adults and for dependence and abuse risk
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.