Temazepam
| Evidence Level: L2 | Predicted Indications: 1 |
Table of Contents
Temazepam: From Insomnia to Sleep Disorder, Initiating and Maintaining Sleep
One-Sentence Summary
Temazepam is a benzodiazepine hypnotic conventionally used for the short-term treatment of insomnia, although the specific approved indication text and mechanism of action were not captured in this Evidence Pack. The TxGNN model predicts it may be effective for Sleep Disorder, Initiating and Maintaining Sleep, a finding that closely mirrors the drug’s already-established clinical use rather than representing a genuinely novel indication. This direction is currently supported by 0 registered clinical trials and 20 publications, including at least one completed Phase III randomised controlled trial specific to temazepam.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in the Evidence Pack (data gap); temazepam is a benzodiazepine conventionally indicated for short-term treatment of insomnia |
| Predicted New Indication | Sleep Disorder, Initiating and Maintaining Sleep |
| TxGNN Prediction Score | 99.82% |
| Evidence Level | L2 |
| UK Market Status | Not marketed (per Evidence Pack) |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for temazepam in this Evidence Pack. Based on general pharmacological knowledge, temazepam is a benzodiazepine receptor agonist that potentiates GABA-A receptor activity, producing sedative-hypnotic effects. It belongs to the same pharmacological class as flurazepam, triazolam and midazolam, all of which are historically used for insomnia management.
The predicted indication — sleep disorder involving difficulty initiating and maintaining sleep (insomnia) — overlaps substantially with temazepam’s long-standing clinical use as a short-acting hypnotic. Rather than identifying a truly new therapeutic area, the TxGNN model here appears to have recovered a well-established drug-disease relationship, which can be viewed as a validation of the model’s predictive accuracy for this candidate.
Mechanistically, this association is highly plausible: temazepam’s sedative and sleep-maintenance properties have been documented in the pharmacological literature since the 1970s–1980s, and it remains referenced in contemporary sleep medicine guidelines as one of several benzodiazepine hypnotics used when non-pharmacological therapy is insufficient.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39304187 | 2024 | RCT (Phase III) | Journal of Palliative Medicine | Three-arm, double-blind trial of temazepam vs. melatonin PR vs. placebo for insomnia in advanced cancer patients |
| 342551 | 1978 | Clinical/Sleep Lab Study | Journal of Clinical Pharmacology | Sleep laboratory evaluation of temazepam 30 mg for sleep induction and maintenance across short-, intermediate- and long-term use |
| 2859305 | 1985 | RCT | Journal of Clinical Psychopharmacology | Multicentre double-blind sleep lab study comparing midazolam and temazepam vs. placebo for sleep maintenance insomnia |
| 6149491 | 1984 | RCT | Neuropsychobiology | Comparison of temazepam and flurazepam showing marked improvement in sleep quality, depth and duration vs. placebo |
| 2567741 | 1989 | Review | Journal of Clinical Psychopharmacology | Critical review of rebound insomnia following discontinuation of short half-life hypnotics including temazepam |
| 1319429 | 1992 | Review | The Journal of Clinical Psychiatry | Historical review noting temazepam and triazolam replaced flurazepam as shorter half-life benzodiazepine hypnotics |
| 33249496 | 2021 | Systematic Review / Network Meta-analysis | Sleep | Comparative efficacy and safety of hypnotics, including benzodiazepines, for insomnia in older adults |
| 27998379 | 2017 | Clinical Practice Guideline | Journal of Clinical Sleep Medicine | AASM guideline on pharmacologic treatment of chronic insomnia, covering individual hypnotic agents |
| 27751669 | 2016 | Review | Clinical Therapeutics | Review of safety and efficacy of sleep medications, with focus on altered pharmacokinetics in older adults |
| 30058034 | 2018 | Review | Drugs & Aging | Recommendations for pharmacological management of insomnia in elderly patients |
UK Market Information
The Evidence Pack contains no UK marketing authorisation entries for temazepam (total_licenses = 0, market_status = "Not marketed"). No product-level licence data (marketing authorisation number, product name, dosage form) was available for extraction. This should be independently verified against the current MHRA products register, as temazepam is a well-established controlled hypnotic drug that may hold UK authorisations not captured in this Evidence Pack.
Safety Considerations
Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Note: This Evidence Pack flags a Blocking data gap (DG001) for UK-equivalent product label warnings/contraindications, meaning a formal safety review (S1) cannot currently be completed. Temazepam is a Schedule benzodiazepine with recognised class-level risks (sedation, dependence, rebound insomnia on discontinuation, and drug interactions) — the absence of specific SmPC data in this pack does not indicate absence of these risks.
Conclusion and Next Steps
Decision: Hold
Rationale:
- Literature evidence supports temazepam’s established hypnotic efficacy for insomnia, including a completed Phase III RCT, meeting L2 evidence criteria; however, the Blocking data gap on UK product safety information (warnings/contraindications) prevents completion of the mandatory S1 safety assessment, and the drug currently shows no UK marketing authorisation on record in this Evidence Pack.
To proceed, the following is needed:
- UK SmPC/BNF data on warnings, contraindications and drug interactions for temazepam (resolves DG001)
- Confirmed mechanism of action data from DrugBank (resolves DG002)
- Verification of actual UK marketing/licensing status via the MHRA products register, given the discrepancy between the “not marketed” flag and temazepam’s known clinical history
- Registered clinical trial evidence (ClinicalTrials.gov / ISRCTN) specific to the “sleep disorder, initiating and maintaining sleep” indication, since current support is literature-only
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.