Nitrazepam
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Nitrazepam: Wernicke-Korsakoff syndrome
One-Sentence Summary
Nitrazepam is a benzodiazepine originally used to treat insomnia and early myoclonic encephalopathy. Currently no clinical trials are registered, and 20 publications (mostly reviews and comparative or observational reports) are available.
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 |
| 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?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general knowledge of the benzodiazepine class, nitrazepam enhances GABA-A receptor-mediated inhibitory neurotransmission, producing sedative-hypnotic and anticonvulsant effects.
The predicted indication, difficulty initiating and maintaining sleep, is essentially the same as the already-recognised insomnia use. The model’s high score therefore mainly reflects a known indication rather than a new therapeutic direction.
Two other predictions have much weaker support. Acute encephalopathy with biphasic seizures and late reduced diffusion has only a speculative GABAergic anticonvulsant link, and sedation could confound neurological monitoring. Wernicke-Korsakoff syndrome is caused by thiamine deficiency. Benzodiazepines only manage alcohol withdrawal in these patients, may worsen cognitive impairment, and have no clear disease-modifying rationale. Neither has any clinical trials or literature.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 4892037 | 1969 | Clinical observation (includes double-blind trial) | British Medical Journal | Nitrazepam was as effective as butobarbitone as a hypnotic; no untoward effects beyond drowsiness in 27 acute overdoses (up to 80 tablets) |
| 1743245 | 1991 | Double-blind crossover study | Eur J Clin Pharmacol | In 28 insomnia patients, nitrazepam 5 mg/day and oxazepam 25 mg/day both improved sleep induction and quality versus placebo |
| 15252823 | 2004 | Systematic review / meta-analysis | Hum Psychopharmacol | Compared Z-drugs with benzodiazepines (including nitrazepam) for short-term insomnia management |
| 10804040 | 2000 | Review | Drugs | Zolpidem’s hypnotic efficacy was generally comparable to nitrazepam and other benzodiazepines |
| 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 | Clinical report | Br J Psychiatry | Nitrazepam (Mogadon) dependence |
| 15089115 | 2004 | Review | CNS Drugs | Residual “hangover” effects of hypnotics, including daytime sleepiness and psychomotor impairment |
| 20171127 | 2010 | Review | Sleep Med Rev | Hypnotics impair body balance and standing steadiness, with falls and hip fractures reported |
| 19450355 | 2007 | Review | BMJ Clin Evid | Insomnia in the elderly: prevalence rises with age |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 160586 | Nigap 5mg Tablet | Strip of 10 tablets | Not stated |
| 202518 | Sopor 10mg Tablet | Strip of 10 tablets | Not stated |
| 150815 | Nitrosun 5mg Tablet | Strip of 10 tablets | Not stated |
| 64806 | Dormin 5mg Capsule | Strip of 10 capsules | Not stated |
| 156791 | Nitraz 5mg Tablet SR | Strip of 10 tablet SR | Not stated |
All 20 registrations are valid single-ingredient products, and none has been cancelled.
Safety Considerations
Drug-interaction screening identified 55 potential interacting drugs. The interaction severity level is not classified for any of them. Examples include morphine, bupropion, metoclopramide, metformin, dexamethasone and omeprazole.
Literature on the class highlights residual daytime impairment, impaired balance with fall and fracture risk, and dependence with long-term benzodiazepine use. Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction duplicates nitrazepam’s existing insomnia use, so it is not a true repurposing opportunity. The other two predictions (acute encephalopathy with biphasic seizures, Wernicke-Korsakoff syndrome) have no clinical or literature support and only speculative mechanistic links. Package insert safety information is also missing.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulatory source, needed before safety screening
- Detailed mechanism of action data (for example from DrugBank)
- Clarification of whether any genuinely new indication, distinct from insomnia, is worth pursuing
- Severity grading of the 55 identified drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.