Modafinil
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Modafinil: Insomnia (disease)
One-Sentence Summary
Modafinil is a wake-promoting medicine used to treat excessive daytime sleepiness. The TxGNN model predicts it may be relevant for insomnia (disease), but the evidence is thin: one completed Phase 4 study in primary insomnia has no published or posted results, and the rest of the literature concerns daytime sleepiness and fatigue rather than insomnia. The evidence level is L5.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Insomnia (disease) |
| TxGNN Prediction Score | 0.9985 |
| 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. Modafinil is generally understood to act through dopamine transporter inhibition and effects on wake-promoting brain circuits, which is aimed at excessive daytime sleepiness rather than at insomnia itself.
The high model score probably reflects the drug’s close association with other sleep and wake disorders, not a demonstrated therapeutic link. A wake-promoting drug might help daytime function in people with disturbed sleep, but it would not be expected to improve insomnia directly and could worsen it. The mechanistic rationale is therefore indirect and weak.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00124384 | Phase 4 | Completed | 40 | Modafinil alone or with cognitive behavioral therapy for insomnia (CBT-I) in primary insomnia, looking at daytime functioning and insomnia severity. No results published or posted. |
| NCT00626210 | Phase 4 | Terminated | 2 | Sleep/wake disturbances in older adults. Stopped after only 2 participants, so no usable data. |
Literature Evidence
None of the publications below studies modafinil in insomnia directly. They cover related sleep, daytime sleepiness and fatigue topics.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27010071 | 2016 | Systematic review/meta-analysis | Parkinsonism & Related Disorders | Drug treatments for daytime sleepiness and sleep disorders in Parkinson’s disease |
| 24312590 | 2013 | Systematic review/meta-analysis | PLoS One | Modafinil for fatigue and excessive daytime sleepiness in neurological disorders |
| 18729534 | 2008 | Review | Drugs | Evidence-based review of approved and investigational uses of modafinil |
| 22021174 | 2011 | Review | Movement Disorders | Evidence review of treatments for non-motor symptoms of Parkinson’s disease |
| 17181377 | 2006 | Review | Drugs | Burden and management of shift work sleep disorder |
| 24272458 | 2014 | Review | Neurotherapeutics | Treatment of sleep disorders in Parkinson’s disease |
| 17060310 | 2006 | Case series | Am J Hosp Palliat Care | Modafinil reduced fatigue in Charcot-Marie-Tooth disease type 1A |
India Market Information
At least 20 single-ingredient licences are recorded, all valid, and the list may be partial. Main examples:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 133436 | Modalert 100 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated |
| 133512 | Modalert 200 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated |
| 136380 | Modapro 200mg Tablet (Cipla Ltd) | Strip of 10 tablets | Not stated |
| 136418 | Modafil 200mg Tablet (Intas Pharmaceuticals Ltd) | Strip of 10 tablets | Not stated |
| 137140 | Modaheal 200mg Tablet (Healing Pharma India Pvt Ltd) | Strip of 10 tablets | Not stated |
Safety Considerations
- Interactions: 249 drug interactions are recorded. Moderate-level examples include omeprazole, esomeprazole, rabeprazole, dexamethasone, eliglustat, linagliptin and cisapride. Minor-level examples include hydrocortisone, pioglitazone and clarithromycin.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The model score is very high, but the only insomnia-specific trial has no available results and the other studies address daytime sleepiness or fatigue. The wake-promoting mechanism does not point to a benefit for insomnia itself, so the evidence level is L5.
To proceed, the following is needed:
- Published or posted results from the completed Phase 4 insomnia study (NCT00124384)
- A well-designed controlled trial of modafinil in insomnia
- Detailed mechanism of action data
- Package insert warnings and contraindications for safety screening
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.