Oxazepam
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
Oxazepam: From Alcohol Withdrawal Delirium and Anxiety to Insomnia
One-Sentence Summary
Oxazepam is a short-acting benzodiazepine originally used for anxiety and alcohol withdrawal delirium. The TxGNN model predicts it may be effective for insomnia, but there are currently 0 registered clinical trials and only 2 directly relevant publications (small clinical studies) supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Alcohol withdrawal delirium; anxiety (US label indication text is not available) |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L3 |
| US Market Status | Cancelled only (all 3 listed authorizations are cancelled) |
| Number of NDAs | 3 (all are ANDAs, generic applications) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for oxazepam is not available in the data compiled for this report. Based on established class pharmacology, oxazepam is a short-acting benzodiazepine that enhances GABA-A receptor-mediated inhibitory neurotransmission, producing anxiolytic and sedative-hypnotic effects.
Anxiety and insomnia frequently occur together, and other benzodiazepines are already used as hypnotics. Enhanced inhibitory signalling is plausibly linked to easier sleep onset and better sleep maintenance. The high TxGNN score is consistent with this class-level reasoning, but it is a computational prediction and not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Most of the retrieved literature is only loosely related to oxazepam in insomnia. The publications that bear directly on the question are listed first.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6691478 | 1984 | Clinical trial | Am J Psychiatry | In 14 patients with chronic insomnia, oxazepam and flurazepam both improved some polysomnographic sleep measures. Flurazepam caused substantial daytime sleepiness, whereas oxazepam did not. Some rebound effects were noted with oxazepam. |
| 29749262 | 2018 | Randomized clinical trial | Ann Pharmacother | Melatonin compared with oxazepam for anxiety and sleep quality in patients with STEMI after primary PCI. |
| 17317444 | 2007 | Study of hypnotics (labelled as review) | Arch Gerontol Geriatr | Effectiveness and safety of hypnotic drugs for insomnia in 60 people over 70 with comorbid conditions. |
| 29844949 | 2018 | Observational | PeerJ | Potentially inappropriate long-term use of benzodiazepines and z-drugs in older adults. |
| 6139491 | 1983 | Clinical study | JAMA | Withdrawal syndrome 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 patients with alcoholic liver disease. |
The remaining retrieved publications (a paroxetine review in panic disorder, an agomelatine case report, and a review of dementia behavioural symptoms) are not specific to oxazepam or insomnia and are not summarized here.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA072253 | Oxazepam (American Health Packaging) | Capsule, gelatin coated | Not available (cancelled) |
| ANDA218261 | Oxazepam (Leading Pharma, LLC) | Capsule | Not available (cancelled) |
| ANDA071026 | Oxazepam (TruPharma, LLC) | Capsule | Not available (cancelled) |
Safety Considerations
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for safety information.
- Contraindication-related conditions (from the knowledge graph, not label text): anxiety disorder, neurotic disorder, dysthymic disorder, porphyria (including inherited forms), kidney disease, liver disease, gallbladder disease, psychotic and schizophrenia-spectrum disorders, mental disorder, hypotensive disorder, sleep apnea syndromes, congenital central hypoventilation syndrome, respiratory failure, lung disease, substance-related disorder and substance abuse/dependence, personality disorder, and intermittent explosive disorder. These should be verified against the official label.
- Drug Interactions: 100 interactions were identified in total. The main ones listed here are:
- Major: morphine, including liposomal morphine (additive central nervous system and respiratory depression is a known concern with opioids).
- Moderate: bupropion, dronabinol, nabilone, metoclopramide, opium, sibutramine, teduglutide.
- Minor: antacids and minerals such as magnesium oxide, magnesium carbonate, magnesium hydroxide, calcium carbonate, aluminum hydroxide and magaldrate.
- Several benzodiazepine-specific concerns also appear in the literature: daytime sleepiness and rebound effects, withdrawal symptoms after switching agents (PMID 6139491), and inappropriate long-term use in older adults (PMID 29844949).
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible, but direct evidence is limited to one small 1984 comparative study (14 patients) and one trial in a cardiac population where sleep was a secondary outcome. No clinical trials are registered. All US authorizations for oxazepam are cancelled, and safety label data are missing, so the evidence level is L3 and the candidate is best treated as a research question.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- A systematic review of benzodiazepines, including oxazepam, for insomnia, and comparison against approved hypnotics
- Clarification of the current US market status, since all listed authorizations are cancelled
- A risk assessment for dependence, respiratory depression, and use in older adults
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.