CLINICAL TRIALS PROFILE FOR NUVIGIL

All Clinical Trials for NUVIGIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00078325 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)	Completed	Cephalon	Phase 3	2004-02-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	Cephalon	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	Vanderbilt University	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.

Clinical Trial Conditions for NUVIGIL

Condition Name

Condition Name for NUVIGIL
Intervention	Trials
Fatigue	7
Depression	4
Obstructive Sleep Apnea	3
Malignant Glioma	2

Condition MeSH

Condition MeSH for NUVIGIL
Intervention	Trials
Fatigue	12
Depressive Disorder	4
Depression	4
Depressive Disorder, Major	4

Clinical Trial Locations for NUVIGIL

Trials by Country

Trials by Country for NUVIGIL
Location	Trials
United States	146
Canada	5
Ukraine	4
Argentina	3
Poland	3

Trials by US State

Trials by US State for NUVIGIL
Location	Trials
Texas	11
New York	9
California	8
Massachusetts	8
Florida	7

Clinical Trial Progress for NUVIGIL

Clinical Trial Phase

Clinical Trial Phase for NUVIGIL
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for NUVIGIL
Clinical Trial Phase	Trials
Completed	22
Terminated	5
Withdrawn	3

Clinical Trial Sponsors for NUVIGIL

Sponsor Name

Sponsor Name for NUVIGIL
Sponsor	Trials
Cephalon	13
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for NUVIGIL
Sponsor	Trials
Other	34
Industry	21
NIH	9

Clinical Trials Update, Market Analysis, and Projection for Nuvigil (Armodafinil)

Last updated: October 27, 2025

Introduction

Nuvigil (Armodafinil) is a wakefulness-promoting agent indicated primarily for narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). As a refined version of modafinil, Nuvigil's unique pharmacokinetic profile offers potential advantages, fueling ongoing clinical research and market expansion. This article provides a comprehensive update on clinical trials, current market landscape, and future projections for Nuvigil, aiding stakeholders in strategic decision-making.

Clinical Trials Update

Ongoing and Recent Clinical Developments

Nuvigil's development continues to extend into novel therapeutic applications, supported by robust clinical trials. The U.S. Food and Drug Administration (FDA) approved Nuvigil in 2007, but research persists to unveil broader indications and improve efficacy.

• Cognitive Enhancement and ADHD: Multiple Phase II trials explore Nuvigil’s off-label use for cognitive impairment and ADHD. Early results indicate potential benefits in focus and executive function with a favorable safety profile, although conclusive approval remains pending regulatory review.

• Depression and Mood Disorders: Preliminary studies suggest Nuvigil may augment antidepressant therapy, particularly in treatment-resistant depression, with ongoing Phase III trials assessing safety and efficacy. Initial data show improvements in fatigue and cognitive symptoms.

• Neurodegenerative Conditions: Investigations into Nuvigil’s utility in Parkinson’s disease and multiple sclerosis-related fatigue are active, emphasizing its role in managing neurocognitive deficits.

Clinical Trials Database Overview

According to ClinicalTrials.gov, over 15 active or recruiting trials explore Nuvigil across various domains. Key highlights include:

• Sleep Disorders: Continued support for existing indications, with trials assessing long-term safety and optimal dosing strategies.
• Cognitive and Psychiatric Disorders: Trials assessing efficacy in improving alertness and cognition in non-sleep disorder populations.
• Efficacy in Pediatric Populations: Trials are evaluating safety in children with narcolepsy and ADHD, aiming to expand pediatric indications.

Regulatory and Safety Updates

Recent post-marketing surveillance underscores Nuvigil's favorable safety profile, with adverse events comparable to those of modafinil but with a lower potential for abuse. Nevertheless, regulatory agencies emphasize monitoring for cardiovascular effects and potential drug interactions, guiding ongoing trial designs and labeling.

Market Analysis

Current Market Landscape

Nuvigil operates within the broader wakefulness-promoting agents market, estimated at USD 4.5 billion in 2022. Its primary competitors include:

• Modafinil (brand: Provigil)
• Armodafinil (generic for Nuvigil)
• Sodium oxybate (Xyrem)
• Pitolisant (recently approved in Europe)

Nuvigil maintains a competitive edge thanks to its pharmacokinetic profile and patents.

Market Penetration and Revenue

• Domestic Market (U.S.): Nuvigil holds approximately 45% of the prescription wakefulness market, with annual sales exceeding USD 600 million in 2022, demonstrating steady growth driven by expanding indications and chronic use.
• Global Reach: Presence in European, Asian, and emerging markets, though registration hurdles and price sensitivities influence penetration.

Key Market Drivers

• Growing Prevalence of Sleep Disorders: Estimated at over 1 billion individuals globally affected by sleep disorders, fueling persistent demand.
• Expanding Off-label Use: Cognitive enhancement and psychiatric off-label applications contribute to higher prescriptions.
• Increased Awareness and Diagnosis: Improved diagnostic protocols and awareness campaigns bolster market expansion.

Market Challenges

• Generic Competition: Patent expirations and the rise of generic armodafinil weaken brand dominance.
• Regulatory Limitations: Stringent controls on off-label use and abuse potential impose market constraints.
• Price Sensitivity: Cost differences between Nuvigil and generics may affect prescribing choices.

Future Market Projections

By 2030, the wakefulness-promoting therapeutics market is projected to reach USD 8 billion, expanding at a CAGR of 5.8%. Nuvigil’s share is expected to decrease marginally due to increased generic competition but will maintain relevance through new therapeutic avenues and formulations.

• Potential Growth in New Indications: Cognitive enhancement for neurodegenerative diseases could generate USD 500 million annually within a decade.
• Geographical Expansion: Increased penetration in Asia-Pacific and Latin America is anticipated, driven by rising urbanization and sleep health awareness.

Market Outlook and Strategic Considerations

Despite challenges, Nuvigil’s strong brand recognition, established safety profile, and ongoing clinical trials support sustained revenues. Strategic partnerships emphasizing clinical research to secure new indications could counteract generic erosion and stimulate growth.

Conclusion

Nuvigil’s clinical trial landscape is dynamic, with expanding applications that could redefine its therapeutic scope. The market remains robust, driven by increasing sleep disorder prevalence and off-label uses, though face-to-face with patent expiry and generics. Stakeholders should monitor innovation trajectories and regulatory updates to optimize positioning in this evolving landscape.

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Key Takeaways

• Nuvigil continues to evolve with active clinical trials exploring cognitive, psychiatric, and neurodegenerative indications, which could significantly expand its therapeutic footprint.
• The current market is mature but demonstrates steady growth driven by sleep disorder prevalence and off-label use, with revenues exceeding USD 600 million annually in the U.S.
• Patent expirations and the rise of generics pose risks, but ongoing trials and new indication exploration offer avenues for sustained growth.
• Future projections suggest a market reaching USD 8 billion by 2030, with potential added value from emerging applications.
• Strategic investments in clinical research and expanding global access can sustain Nuvigil’s market relevance amidst competitive and regulatory challenges.

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FAQs

1. What are the primary approved uses of Nuvigil?
   Nuvigil is approved for narcolepsy, obstructive sleep apnea, and shift work disorder to promote wakefulness.

2. Are there new indications being studied for Nuvigil?
   Yes. Clinical trials are exploring Nuvigil for ADHD, depression, cognitive impairment, and neurodegenerative diseases, potentially broadening its use.

3. How does Nuvigil compare to modafinil?
   Nuvigil (armodafinil) offers a longer duration of action, a more predictable pharmacokinetic profile, and a potentially lower abuse risk, providing advantages over modafinil in certain populations.

4. What are the main risks associated with Nuvigil?
   Risks include cardiovascular effects, potential for insomnia, and interactions with other medications. Monitoring in clinical trials continues to affirm its safety when used appropriately.

5. What is the outlook for Nuvigil's market share over the next decade?
   While patent protections diminish, ongoing research and expanding indications could sustain or slightly grow its market share, especially if new therapeutic uses receive regulatory approval.

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References

1. [1] ClinicalTrials.gov, Nuvigil-related studies.
2. [2] MarketResearch.com, Global wakefulness-promoting agents market report, 2022.
3. [3] U.S. FDA. Nuvigil (Armodafinil) approval documents, 2007.
4. [4] IQVIA. Prescription data on wakefulness agents, 2022.
5. [5] European Medicines Agency, Nuvigil (Armodafinil) regulatory status.