Diazepam
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Diazepam: Insomnia (disease)
One-Sentence Summary
Diazepam is a long-acting benzodiazepine that enhances GABA-A receptor signalling and has sedative-hypnotic effects. The TxGNN model predicts it may be useful for insomnia. Evidence is limited: 0 registered clinical trials and 1 older double-blind comparative study in insomnia patients, among 17 publications compiled, most of them reviews or preclinical work.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L2 |
| 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 for diazepam are not available in the data compiled for this report. Based on known pharmacology, diazepam is a positive allosteric modulator of GABA-A receptors, which produces sedative-hypnotic effects. This makes a role in sleep disorders biologically plausible, and benzodiazepines as a class are already used for short-term insomnia.
There are important limits. Diazepam has a long half-life and an active metabolite (nordiazepam), which can cause residual daytime sedation. Long-term use carries risks of dependence and cognitive effects. The only direct study in insomnia patients is a 1981 double-blind trial against another benzodiazepine, not against placebo. Most other retrieved papers are reviews, herbal-medicine studies or animal studies that use diazepam as a positive control.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6113175 | 1981 | Double-blind comparative trial | J Int Med Res | 100 outpatients with insomnia; lormetazepam 1 mg was significantly better than diazepam 5 mg at shortening time to fall asleep over 7 days |
| 39581171 | 2024 | Review | Bioorg Chem | GABA-A modulators including diazepam are used for neurological and psychiatric conditions, with sedation-related side effects |
| 23330992 | 2013 | Review | Expert Opin Drug Metab Toxicol | Pharmacokinetics of anxiolytic and hypnotic drugs |
| 36692463 | 2023 | Meta-analysis | Acta Pharm | Tranquilizer use in elderly patients: dose, outcomes and adverse effects |
| 40583063 | 2025 | Cohort | Cell Mol Biol Lett | Long-term benzodiazepine and Z-drug use was linked to higher breast cancer risk |
| 31770357 | 2019 | Review | Med Lett Drugs Ther | Cannabis and cannabinoids overview |
| 29479317 | 2018 | Review | Front Pharmacol | Suanzaoren herbal formulae for insomnia (not diazepam-specific) |
| 32623439 | 2020 | Preclinical | Med Sci Monit | Berberine in insomnia rats, with diazepam as the comparator |
| 37776625 | 2023 | Preclinical | J Pharm Biomed Anal | Naoling Pian in insomnia rats, with diazepam as the positive control |
| 16671957 | 2006 | Survey | Fundam Clin Pharmacol | Benzodiazepine prescribing habits in Dakar; concerns about addiction |
India Market Information
Diazepam-containing products are marketed in India. The data compiled for this report show 20 valid licences and no cancelled ones. This list may be partial. Approved indication text is not recorded for these licences. Selected single-strength products:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 114346 | Juniz Rds 2.5mg Suppository | Packet of 5 suppositories | Not recorded |
| 66332 | Deprid M 2mg/12.5mg Tablet | Strip of 10 tablets | Not recorded |
| 69654 | Deparis Fort 5mg/25mg Tablet | Strip of 10 tablets | Not recorded |
| 178280 | Prazep 2 mg/25 mg Tablet | Strip of 10 tablets | Not recorded |
| 61484 | Diaze 5mg Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
- Drug Interactions: 295 interactions are recorded. Morphine is listed as Major, since combining it with diazepam risks additive central nervous system and respiratory depression. Moderate interactions include bupropion, aprepitant, omeprazole, esomeprazole, cimetidine, clarithromycin, cisapride, clotrimazole, miconazole, dronabinol and metoclopramide. Dexamethasone, betamethasone and several antacids are Minor.
- Literature signals: The retrieved papers describe dependence, withdrawal difficulty and inappropriate long-term prescribing of benzodiazepines. One cohort study links prolonged use to higher breast cancer risk.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible, and the one direct study in insomnia patients (a 1981 double-blind comparison with lormetazepam, in which diazepam performed worse) supports an L2 evidence level. It is old and has no placebo arm. The wider literature emphasises dependence and long-term harm, and newer hypnotics are displacing benzodiazepines.
To proceed, the following is needed:
- A placebo-controlled or modern active-comparator trial of diazepam in insomnia
- Detailed mechanism-of-action data
- Label warnings and contraindications from the package insert
- A risk plan covering dependence, residual daytime sedation, falls in older adults, and opioid co-prescription
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.