Armodafinil
| Evidence Level: L2 | Predicted Indications: 1 |
Table of Contents
Armodafinil: From Narcolepsy to Insomnia
One-Sentence Summary
Armodafinil is a wakefulness-promoting agent (the R-enantiomer of modafinil), originally used for sleep-wake conditions such as narcolepsy. The TxGNN model predicts it may be effective for insomnia, with 3 clinical trials and 2 publications currently linked to this direction. The evidence is weak: the trials mostly address daytime sleepiness and fatigue in patients who also have insomnia, not insomnia itself.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Narcolepsy (also listed: narcolepsy-cataplexy syndrome, central nervous system disease, Balo concentric sclerosis, X-linked adrenoleukodystrophy) |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 0.9989 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (14 of 14) – CDSCO approval status is not included in this data |
| Number of Listed Products | 14 (valid: 14) |
| Recommended Decision | Hold |
Note: the Indian licence records compiled for this report contain no approved-indication text, so the original indication is taken from the indication list compiled for this report.
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available. Armodafinil is a wakefulness-promoting drug and is thought to act mainly by inhibiting the dopamine transporter, which raises wakefulness. Its efficacy in narcolepsy and related sleepiness disorders is established.
This is pharmacologically the opposite of treating insomnia as a primary problem of falling or staying asleep. The plausible link is indirect. In the available trials, armodafinil targets daytime sleepiness, fatigue, or wake-related impairment in people whose insomnia occurs alongside breast cancer, chemotherapy-related fatigue, or sleep-disordered breathing. It is not a direct treatment for insomnia.
The very high TxGNN score (0.9989) is a computational prediction. It likely reflects network proximity to sleep-wake disorders such as narcolepsy and shift work sleep disorder, not a true therapeutic mechanism. It should not be read as evidence of efficacy.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01091974 | Phase 2 | Completed | 138 | Four-arm randomized trial of CBT for insomnia with or without armodafinil for insomnia and fatigue after chemotherapy in breast cancer survivors. This is the closest to a controlled test of armodafinil’s added effect, but the effect on insomnia itself still needs confirmation. |
| NCT01011218 | Phase 2 | Completed | 70 | Pilot study of brief or full behavioral therapy for insomnia, with or without armodafinil 150 mg/day, in breast cancer patients. Preliminary evidence only. |
| NCT02552303 | Not applicable | Completed | 39 | Armodafinil, CBT-I, or both in insomnia comorbid with obstructive sleep apnea. Small sample and mixed interventions limit conclusions about armodafinil alone. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21904092 | 2011 | Review | Postgraduate Medicine | Reviews emerging theories and therapies for shift work disorder, which involves excessive sleepiness at work and/or insomnia during scheduled sleep. |
| 17181377 | 2006 | Review | Drugs | Burden of illness and management approaches for shift work sleep disorder, a condition often under-recognised and undertreated. |
Both publications are reviews of shift work disorder, not direct studies of armodafinil in primary insomnia.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 237994 | Vigilant 200mg Tablet (Taj Pharma India Ltd) | Strip of 10 tablets | Not stated in the compiled records |
| 241564 | Waklert 100mg Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated in the compiled records |
| 241449 | Waklert 150 Tablet (Sun Pharmaceutical Industries Ltd) | Strip of 10 tablets | Not stated in the compiled records |
| 242163 | Walkalarm 150mg Tablet (Ryon Pharma) | Strip of 10 tablets | Not stated in the compiled records |
| 684 | Armod 50 Tablet (Emcure Pharmaceuticals Ltd) | Strip of 10 tablets | Not stated in the compiled records |
There are 14 valid single-ingredient registrations in total, all oral tablets. None are cancelled.
Safety Considerations
- Contraindications suggested by the knowledge graph (not label text): hypertension and hypertensive disorder, liver failure, anxiety disorder, neurotic disorder, dysthymic disorder, psychotic disorder, schizophreniform disorder, schizoaffective disorder, mental disorder, mitral valve prolapse (including familial form), postural orthostatic tachycardia syndrome, and congenital mitral valve insufficiency.
- Drug Interactions: 170 interactions were identified. Moderate-level ones include rabeprazole, esomeprazole, cisapride, dexamethasone, eliglustat, and linagliptin. Minor-level ones include hydrocortisone, pioglitazone, aprepitant, cimetidine, and clarithromycin.
These contraindications come from a knowledge graph and need confirmation against the official package insert. The psychiatric and cardiovascular items are also relevant to insomnia patients, a group with frequent anxiety and mood comorbidity.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism of armodafinil (wakefulness promotion) runs counter to treating primary insomnia. The trials found are small, focus on fatigue or sleepiness in comorbid populations, and are not placebo-controlled tests of insomnia benefit. The high TxGNN score is not clinical evidence. The knowledge graph also lists psychiatric and cardiovascular contraindications.
To proceed, the following is needed:
- Published results for NCT01091974, especially the insomnia outcomes and whether it had a placebo control
- Detailed mechanism of action data
- Package insert warnings and contraindications from the Indian regulator or manufacturers
- Confirmation of the knowledge-graph contraindications against official labelling
- A clear clinical rationale for any insomnia subgroup (such as comorbid fatigue or sleep apnea) in which armodafinil might help
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.