NUVIGIL (armodafinil)
Nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, shift work disorder (SWD), or obstructive sleep apnea (OSA). In patients with OSA, Nuvigil is intended to treat the symptom of sleepiness rather than the underlying airway obstruction. For these patients, a maximal effort to treat the obstruction with continuous positive airway pressure (CPAP) should be made for an adequate period before initiating Nuvigil.
How NUVIGIL Works
The precise mechanism through which armodafinil promotes wakefulness is unknown. Armodafinil is an indirect dopamine receptor agonist; it binds to the dopamine transporter and inhibits dopamine reuptake, which increases extracellular dopamine levels in certain brain regions. Animal studies suggest that its wake-promoting activity is dependent on the dopamine transporter. While armodafinil has pharmacological properties similar to sympathomimetic agents like amphetamine, its overall pharmacologic profile is not identical.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-06-15
- Routes
- ORAL
- Dosage Forms
- TABLET
NUVIGIL Approval History
What NUVIGIL Treats
3 indicationsNUVIGIL is approved for 3 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obstructive Sleep Apnea
- Narcolepsy
- Shift Work Disorder
NUVIGIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NUVIGIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NUVIGIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NUVIGIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
31 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01330446 results posted | 2010-0557 R01 026582-26, NCI-2011-00881 | Ph 1, Ph 2 | completed | Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer |
| NCT00983437 results posted | C10953/3069/ES/MN | Ph 3 | terminated | Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury |
| NCT00893789 results posted | C10953/3067/ES/MN | Ph 3 | terminated | Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury |
| NCT01624480 | C10953/1100 2012-005510-20 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy |
| NCT01032200 results posted | IRB00012856 U10CA081851, REBACCCWFU97509 | Ph 2 | completed | Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors |
| NCT01096680 results posted | SPD489-207 | Ph 2 | completed | Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss |
| NCT01019187 | UPCC 19108 | Ph 2 | completed | Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy |
| NCT01896128 results posted | BRC-394 | Ph 2 | completed | Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke |
| NCT02468856 | IRB201500170 OCR16236 | Ph 1 | completed | Effect of Armodafinil on Simulated Driving |
| NCT02478580 results posted | 10-041 | Ph 3 | completed | Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients |
| NCT01011218 results posted | IRB-17323 K07CA132916-01A1, 25740 | Ph 2 | completed | Management of Insomnia in Breast Cancer Patients |
| NCT01121536 results posted | C10953/3074 2009-016648-38 | Ph 3 | terminated | Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder |
| NCT01746043 results posted | 2012-0117 NCI-2013-00584, R01CA026582 | Ph 2 | completed | A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer |
| NCT02151253 results posted | Pro00028116 | Ph 2, Ph 3 | completed | Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia |
| NCT01460628 results posted | 2011P-001055 | Ph 4 | completed | Effect of Nuvigil on Fatigue |
| NCT01470651 results posted | C10953/6285 | Ph 4 | terminated | Armodafinil for Patients Starting Hepatitis C Virus Treatment |
| NCT01091974 results posted | UCCS07090 1R01CA126968-01A1 | Ph 2 | completed | Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy |
| NCT00766467 results posted | 07-341 | Ph 2 | completed | A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas |
| NCT01305408 results posted | C10953/3073 2010-023623-26 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder |
| NCT01072630 results posted | C10953/3072 2009-016634-27 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder |
| NCT01072929 results posted | C10953/3071 2009-016667-11 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder |
| NCT01010789 | Cephalon_001 | Ph 3 | completed | Armodafinil in Binge Eating Disorder (BED) |
| NCT01219673 results posted | 2009-0517 R01 026582-26 | Ph 1, Ph 2 | terminated | Symptom Burden in Head and Neck Cancer |
| NCT01160380 results posted | C10953/6270 | Ph 3 | completed | A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma |
| NCT00737204 results posted | #4839/5892R R01MH072383-02 | Ph 4 | completed | Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS |
| NCT00981084 results posted | C10953/6113 | Ph 2, Ph 3 | completed | Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) |
| NCT01023672 results posted | 09-003438 R01AG015866, P50AG016574 | Ph 4 | completed | "Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies" |
| NCT00758498 results posted | C10953/3065/ES/MN | Ph 3 | completed | Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder |
| NCT00711516 results posted | C10953/4026/AP/US | Ph 4 | completed | Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance |
| NCT00772005 results posted | C10953/2034/SZ/MN | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia |
| NCT01080807 results posted | C10953/4030 | Ph 4 | completed | Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NUVIGIL FDA Label Details
Indications & Usage
FDA Label (PDF)NUVIGIL is indicated for the treatment of Obstructive Sleep Apnea; Narcolepsy; Shift Work Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment