Oxazepam
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
Oxazepam: Insomnia (disease)
One-Sentence Summary
Oxazepam is a short-acting benzodiazepine, originally used to treat anxiety and alcohol withdrawal delirium. The TxGNN model predicts it may be effective for insomnia, with no registered clinical trials but 10 publications retrieved, of which only a few directly address oxazepam in insomnia or sleep quality.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 0.9986 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (15 of 15) – CDSCO approval status is not included in this data |
| Number of Listed Products | 15 (valid: 15) |
| 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 known class pharmacology, oxazepam is a short-acting benzodiazepine that enhances inhibitory GABA-A receptor signalling. This underlies its anxiolytic and sedative effects. It is cleared by direct glucuronidation without active metabolites, which gives a relatively predictable profile.
Anxiety and insomnia commonly occur together, and the sedative-hypnotic effect of GABA-A modulation is directly relevant to sleep initiation and maintenance. The prediction is therefore mechanistically plausible. It is better seen as a natural extension of existing anxiolytic and sedative use than as a truly novel repurposing. Some product labelling may already cover short-term insomnia associated with anxiety, but this could not be confirmed from the available data.
The high TxGNN score is a computational prediction and does not count as clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6691478 | 1984 | Comparative clinical trial | Am J Psychiatry | In 14 chronic insomnia patients, oxazepam and flurazepam both improved some polysomnographic sleep measures; flurazepam caused substantial daytime sleepiness, oxazepam did not. |
| 29749262 | 2018 | Randomized clinical trial | Ann Pharmacother | Melatonin vs oxazepam on anxiety and sleep quality in STEMI patients after primary PCI. |
| 17317444 | 2007 | Review/Meta-analysis | Arch Gerontol Geriatr | Effectiveness and safety of hypnotic drugs for insomnia in people over 70. |
| 29844949 | 2018 | Observational | PeerJ | Factors associated with potentially inappropriate long-term benzodiazepine and z-drug use in older adults. |
| 6139491 | 1983 | Clinical study | JAMA | Withdrawal syndrome in two patients after switching from a long-acting to a short-acting benzodiazepine (including oxazepam). |
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Pharmacokinetics of anxiolytic drugs. |
| 36340306 | 2022 | Review | J Clin Exp Hepatol | Management of alcohol withdrawal syndrome in alcoholic liver disease (indirect). |
| 15633073 | 2005 | Review | Psychiatr Prax | Management of behavioural and psychological symptoms of dementia (indirect). |
Two further retrieved papers (an agomelatine case report and a paroxetine panic disorder review) are not relevant to oxazepam and are omitted.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 248667 | Zaxpam 15mg Tablet (Intas Pharmaceuticals Ltd) | Strip of 10 tablets | Not stated in the available records |
| 200873 | Serepax 15mg Tablet (Pfizer Ltd) | Strip of 10 tablets | Not stated in the available records |
| 202070 | Serepax 30mg Tablet (Pfizer Ltd) | Strip of 10 tablets | Not stated in the available records |
| 1847 | Anxozap 30 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated in the available records |
| 10342 | Azenap 30mg Tablet (Consern Pharma Limited) | Strip of 10 tablets | Not stated in the available records |
All 15 registrations are valid single-ingredient oral tablets; none are cancelled.
Safety Considerations
- Contraindications (not label text): anxiety and neurotic disorders, dysthymic disorder, psychotic and schizophrenia-spectrum disorders, personality disorder, intermittent explosive disorder, substance-related disorders and dependence, liver disease, kidney disease, gallbladder disease, porphyria, hypotensive disorder, respiratory failure, lung disease, sleep apnoea syndromes and congenital central hypoventilation syndrome.
- Drug Interactions: 163 interactions were identified. Major interactions include morphine (including liposomal morphine), likely reflecting additive central nervous system and respiratory depression. Moderate interactions include bupropion, dronabinol, nabilone, metoclopramide, opium, sibutramine and teduglutide. Antacids such as magnesium and aluminium salts and calcium carbonate are minor.
Package insert warnings and contraindications are not available in the compiled data, so please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible, but there are no registered clinical trials. Direct evidence is limited to one small 1984 comparative study in 14 patients and one trial in a specialised cardiac population. The high TxGNN score is not clinical evidence, and the insomnia use may overlap with existing sedative or anxiolytic labelling. Package insert safety data are also missing, which blocks safety screening.
To proceed, the following is needed:
- Download and review the India package inserts for warnings, contraindications and approved indications, including whether short-term insomnia is already covered
- Detailed mechanism of action data (for example from DrugBank)
- A structured review of controlled trials of oxazepam in insomnia, compared with other hypnotics
- A safety plan for high-risk groups: older adults, patients with respiratory disease or sleep apnoea, liver or kidney impairment, substance use history, and concurrent opioid use
- Confirmation of the dependence, withdrawal and rebound risks with short-term use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.