Flurazepam
| Evidence Level: L3 | Predicted Indications: 1 |
Table of Contents
- Flurazepam
- Flurazepam: From Insomnia (Known Labeled Use) to Sleep Disorder, Initiating and Maintaining Sleep
Flurazepam: From Insomnia (Known Labeled Use) to Sleep Disorder, Initiating and Maintaining Sleep
One-Sentence Summary
Flurazepam is a benzodiazepine hypnotic, marketed in the US as capsules. The TxGNN model predicts it may be effective for sleep disorder, initiating and maintaining sleep. This is essentially a re-confirmation of a long-established use rather than a new repurposing finding. Currently no clinical trials are registered in the evidence pack, but 20 publications (mostly reviews plus a few controlled studies) support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the US license records (insomnia is its long-established labeled use) |
| Predicted New Indication | Sleep disorder, initiating and maintaining sleep |
| TxGNN Prediction Score | 99.42% |
| Evidence Level | L3 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 2 (both ANDAs) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Flurazepam is a benzodiazepine that acts as a positive allosteric modulator of GABA-A receptors. It enhances inhibitory GABAergic signaling, which produces sedative-hypnotic effects and reduces sleep latency and night-time awakenings. A 2023 cryo-EM study of native GABA-A receptor assemblies (PMID 37730991) supports this mechanism at the structural level. The drug’s original indication and mechanism fields are empty in the evidence pack, so the mechanism above comes from the repurposing rationale and the literature.
The predicted “insomnia (initiating and maintaining sleep)” indication matches how flurazepam has been used since 1970, when it became the first benzodiazepine hypnotic. A 1987 review notes it is effective for both sleep induction and maintenance, and retains most of its efficacy over 4 weeks of nightly use. The high score (0.994) is therefore consistent with a known indication, not a novel one.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38401406 | 2024 | Systematic review / network meta-analysis of RCTs | Eur Neuropsychopharmacol | Assesses residual effects of sleep medications on driving performance (SDLP and first-morning impairment) |
| 7792498 | 1995 | Controlled study (design inferred from title) | Sleep | In 10 insomniacs, placebo vs flurazepam 30 mg vs zolpidem 10 mg, testing how the drugs alter perception of being asleep or awake |
| 7792497 | 1995 | Controlled study (design inferred from title) | Sleep | Same comparison in 15 normal sleepers |
| 2671059 | 1989 | Comparative study | J Clin Psychopharmacol | Brotizolam 0.25 mg vs flurazepam 15 mg vs placebo for 2 weeks in 36 elderly subjects (60-72 years) with chronic insomnia; results not in the available abstract |
| 27751669 | 2016 | Review | Clin Ther | Safety and efficacy of insomnia medications in older adults |
| 3332464 | 1987 | Review | Semin Neurol | Flurazepam is effective for both sleep induction and maintenance and keeps most of its efficacy over 4 weeks of nightly use |
| 2567741 | 1989 | Review | J Clin Psychopharmacol | Reviews rebound insomnia after discontinuation of triazolam, temazepam and flurazepam |
| 1319429 | 1992 | Review | J Clin Psychiatry | Flurazepam was the first benzodiazepine hypnotic (1970) and was later partly replaced by shorter half-life agents |
| 36630579 | 2023 | Review | Med Lett Drugs Ther | Overview of drugs for chronic insomnia |
| 37730991 | 2023 | Structural mechanism study | Nature | Cryo-EM structures of native GABA-A receptor assemblies, a target of hypnotics |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA072368 | Flurazepam Hydrochloride | Capsule (oral) | Chartwell RX, LLC |
| ANDA072369 | Flurazepam Hydrochloride | Capsule (oral) | Chartwell RX, LLC |
Safety Considerations
- Key Warnings, Contraindications and Drug Interactions: The evidence pack has no package-insert warnings or contraindications, and the DDI query returned no results. Please refer to the package insert for safety information.
- From the literature: Residual next-day effects on driving (PMID 38401406), rebound insomnia after discontinuation (PMID 2567741) and safety in older adults (PMID 27751669) are recurring themes.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Insomnia is a long-established use of flurazepam, and the literature supports it. However, the evidence is mostly reviews and older small controlled studies, with no registered trials. The package-insert safety data are also missing.
To proceed, the following is needed:
- Package-insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Confirmation of the original indication text from the label
- Verification of the study design of PMIDs 7792498 and 7792497, which was inferred from titles
- A safety plan for older adults, covering residual sedation and driving, dependence and rebound insomnia
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.