Melitracen
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Melitracen: From a Tricyclic Antidepressant to Insomnia
One-Sentence Summary
Melitracen is a tricyclic antidepressant, marketed in Singapore as a single-ingredient film-coated tablet (DEANXIT). It is usually combined with flupentixol elsewhere. The TxGNN model predicts it may be useful for insomnia, but there are 0 registered clinical trials and only 4 publications, none of which tested melitracen as a treatment for insomnia. This is a model-generated research question, not an evidence-backed indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence record |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 97.24% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available. Melitracen belongs to the tricyclic antidepressant class. Drugs in this class generally have sedative, antihistaminic and anticholinergic properties, and these plausibly relate to sleep disturbance. Insomnia also commonly occurs together with anxiety and depression, which are the conditions this drug is typically used for.
The mechanistic link is therefore inferred from drug class rather than demonstrated for melitracen itself. The approved indication text in the Singapore record is empty, so the relationship between the original and new indication cannot be confirmed from the data compiled for this report.
Other predictions from the model are weaker or unsupported. Headache disorder is plausible by analogy with amitriptyline, and dysthymic disorder is plausible from class and label use. Predictions such as osteoarthritis, pseudoachondroplasia and nephrogenic syndrome of inappropriate antidiuresis have no identifiable mechanistic basis.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 34330350 | 2021 | Cohort | Int J Tuberc Lung Dis | Flupentixol/melitracen was tested in 101 patients with chronic refractory cough who had failed gabapentin and baclofen. It is not an insomnia study. |
| 38315683 | 2024 | Network meta-analysis (labelled RCT) | PLoS One | Eszopiclone-based combination therapy for post-stroke insomnia. Melitracen is not clearly the subject. |
| 25532388 | 2014 | Cohort (real-world) | Zhongguo Zhong Yao Za Zhi | Concurrent diseases and medicine use among 1,067 insomnia patients in 20 hospitals. Drug use was described, and efficacy was not tested. |
| 40827342 | 2025 | Cross-sectional | Psychiatry Clin Psychopharmacol | Insomnia drug use in a Shenzhen Chinese medicine hospital. This is a prescribing description, not a test of melitracen. |
None of these publications provides controlled evidence that melitracen treats insomnia.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN00913P | DEANXIT TABLET (H. Lundbeck A/S) | Tablet, film coated | Not stated in the licence record |
Safety Considerations
- Drug Interactions: No drug interaction records were found for melitracen.
- Class note: Tricyclics can cause hyponatraemia or SIADH-like effects, and sedative and anticholinergic effects are expected from the class. These are general class considerations, not label data for this product.
Please refer to the package insert for full safety information, including warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The insomnia prediction scores highly in the model, but no clinical trials exist and the retrieved literature only describes prescribing patterns or other conditions. The mechanistic link rests on drug class alone, and the safety and label information needed for screening is missing. The other nine predictions have either no evidence or no plausible mechanism.
To proceed, the following is needed:
- The Singapore package insert, to confirm the approved indication, warnings and contraindications
- Mechanism-of-action data from DrugBank
- A targeted literature search for melitracen or flupentixol/melitracen in insomnia, including anxiety- or depression-related insomnia
- A safety assessment of sedation, anticholinergic effects and hyponatraemia in the intended population
- If the above supports it, a small controlled study of melitracen in insomnia
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.