Modafinil
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Modafinil: Insomnia (disease)
One-Sentence Summary
Modafinil is a wake-promoting agent that is already marketed in Australia. The TxGNN model predicts it may be relevant to insomnia, but the supporting evidence is weak: 2 registered clinical trials and 19 retrieved publications, none of which shows a demonstrated benefit in insomnia. The evidence level is L5 and the recommended decision is Hold.
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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for this report. Modafinil is known as a wake-promoting agent that is pharmacologically different from classical stimulants.
The prediction is hard to justify mechanistically. A drug that promotes wakefulness would be expected to work against insomnia treatment, not for it. The retrieved literature describes modafinil mainly for daytime sleepiness and fatigue, including in neurological conditions such as Parkinson’s disease. It does not describe use for insomnia itself.
The high TxGNN score (0.9985) is a model output reflecting how closely modafinil sits to sleep-related conditions in the model’s data. It is not evidence of therapeutic benefit and should not be read as a clinical claim.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT00124384 | Phase 4 | Completed | 40 | Examined modafinil alone or with cognitive behavioural therapy for insomnia (CBT-I) on daytime functioning and insomnia severity in primary insomnia. No results are available in the data compiled for this report. |
| NCT00626210 | Phase 4 | Terminated | 2 | Modafinil for sleep/wake disturbances in older adults. Terminated after only 2 participants, so no usable efficacy data. |
No ANZCTR identifiers were found in the data compiled for this report.
Literature Evidence
None of the publications below reports a controlled study of modafinil in insomnia. They concern daytime sleepiness, fatigue and sleep disturbance in other settings.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24312590 | 2013 | Systematic review/meta-analysis | PLoS One | Assessed safety and effects of modafinil on fatigue and excessive daytime sleepiness in neurological disorders. Earlier trials gave inconsistent results. |
| 18729534 | 2008 | Review | Drugs | Evidence-based review of approved and investigational uses of modafinil, drawn from randomised, placebo-controlled trials. |
| 27010071 | 2016 | Systematic review/meta-analysis | Parkinsonism & Related Disorders | Pharmacological interventions for daytime sleepiness and sleep disorders in Parkinson’s disease. The authors note few clinical trials have been done. |
| 22021174 | 2011 | Review | Movement Disorders | Evidence-based review of treatments for non-motor symptoms of Parkinson’s disease. |
| 24272458 | 2014 | Review | Neurotherapeutics | Treatment of sleep disorders in Parkinson’s disease. Optimal treatments for insomnia in this population are yet to be determined. |
| 17060310 | 2006 | Case series | Am J Hosp Palliat Care | Modafinil and fatigue in Charcot-Marie-Tooth disease type 1A. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 8816B | Modafin | Tablet 100 mg (oral) | Not available in the data compiled |
Safety Considerations
- Drug Interactions: The interaction screen returned 100 records (source: DDInter). Interactions classed as Moderate in the records reviewed include:
- Rabeprazole
- Omeprazole
- Esomeprazole
- Dexamethasone
- Eliglustat
- Linagliptin
- Cisapride
Many others are classed as Minor.
No label-based warnings or contraindications are available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only insomnia-specific trial of modafinil (NCT00124384) has no available results, and the other trial was terminated after 2 participants. The mechanism of a wake-promoting agent also runs counter to the proposed use. The evidence level is therefore L5, and the score alone does not justify progressing.
To proceed, the following is needed:
- Published results from NCT00124384, or new controlled trials of modafinil in insomnia
- A clear mechanistic rationale for how a wake-promoting agent could benefit insomnia
- Mechanism of action data
- Review of the TGA Product Information for warnings, contraindications and interaction management
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.