Nitrazepam
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Nitrazepam: Wernicke-Korsakoff syndrome
One-Sentence Summary
Nitrazepam is a benzodiazepine hypnotic, originally used to treat insomnia and early myoclonic encephalopathy. The TxGNN model predicts it may be effective for Wernicke-Korsakoff syndrome. There are no registered clinical trials and 20 publications (mostly narrative reviews) for this prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Wernicke-Korsakoff syndrome |
| TxGNN Prediction Score | 0.9931 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| 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 pharmacology, nitrazepam is a benzodiazepine that enhances GABA-A receptor signalling, producing sedative-hypnotic effects. This is consistent with treating difficulty initiating and maintaining sleep.
Clinical Trial Evidence
Currently no related clinical trials registered for this predicted indication.
Literature Evidence
The retrieved literature is mostly narrative reviews and general hypnotic-drug articles. Items are listed in priority order (RCT > review > other).
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 4892037 | 1969 | Trial (double-blind, per abstract) | Br Med J | In 27 patients, nitrazepam overdose caused little beyond drowsiness; a double-blind trial found it as effective as butobarbitone as a hypnotic |
| 15252823 | 2004 | Systematic review / meta-analysis | Hum Psychopharmacol | Compared Z-drugs with benzodiazepines (including nitrazepam) for short-term insomnia |
| 19450355 | 2007 | Review | BMJ Clin Evid | Insomnia in the elderly: prevalence, risk factors and management |
| 15089115 | 2004 | Review | CNS Drugs | Residual “hangover” effects of hypnotics and accident risk, dose-dependent |
| 20171127 | 2010 | Review | Sleep Med Rev | Hypnotics impair body balance and standing steadiness; falls and hip fractures reported |
| 10804040 | 2000 | Review | Drugs | Zolpidem efficacy is generally comparable to benzodiazepines including nitrazepam |
| 3281819 | 1988 | Review | Drugs | Brotizolam improved sleep similarly to nitrazepam 2.5 and 5 mg |
| 7037262 | 1981 | Review | Clin Pharmacokinet | Clinical pharmacokinetics of nitrazepam |
| 1125532 | 1975 | Report | Br J Psychiatry | Nitrazepam (Mogadon) dependence |
| 20191849 | 2009 | Review | Rev Med Chir Soc Med Nat Iasi | Benzodiazepine withdrawal syndrome and its management |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 2723H | Alodorm | Tablet 5 mg (oral) | Not available in the data compiled for this report |
Safety Considerations
- Drug Interactions: 55 potential interactions were identified, all with an unclassified severity level. Examples include morphine, metformin, metronidazole, bupropion, metoclopramide, dexamethasone and several proton pump inhibitors. Because severity grading is unavailable, these should be checked against the Product Information. Concurrent opioids and other CNS depressants are of particular concern with benzodiazepines.
- Class-related concerns raised in the retrieved literature: dependence and withdrawal, tolerance, residual daytime impairment, falls and hip fractures, and heightened sensitivity in older adults.
Please refer to the TGA-approved Product Information (PI) for formal warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: Supporting evidence is limited to reviews, with no registered trials. Safety concerns (dependence, falls, sedation in older adults) weigh against expansion.
To proceed, the following is needed:
- Product Information warnings and contraindications, and the approved indication text for the ARTG entry
- Mechanism of action data
- A benefit-risk assessment against established first-line treatments, with particular attention to older adults
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.