Excessive Daytime Sleepiness Pipeline Insight 2025: Amneal's FDA Approval of Sodium Oxybate Oral Solution, Novel Orexin Agonists, and Next-Generation Sleep-Wake Modulators Redefine Narcolepsy Care | D

Excessive Daytime Sleepiness (EDS) is a key symptom of narcolepsy, obstructive sleep apnea, idiopathic hypersomnia, and other neurological disorders. It causes overwhelming fatigue, sudden sleep attacks, and cognitive impairment, significantly affecting daily life and safety. Current treatments, including stimulants, wake-promoting agents, and sodium oxybate, have limitations such as tolerance, side effects, and varying efficacy in some patients.
DelveInsight's "Excessive Daytime Sleepiness - Pipeline Insight, 2025 [https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]" highlights a diverse and growing therapeutic pipeline, featuring orexin receptor agonists, selective dopamine/norepinephrine reuptake inhibitors, histamine H3 antagonists, and novel sleep-wake modulators. These next-generation candidates are being developed to not only alleviate symptoms but also target the underlying neurobiological dysregulation driving hypersomnolence.

A key milestone was achieved in September 2025, when Amneal Pharmaceuticals, Inc. announced that the FDA approved its sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA), which references Jazz Pharmaceuticals' Xyrem Registered . Amneal had previously distributed an authorized generic in limited quantities, but this full approval marks a critical step in broadening patient access to a standard-of-care therapy. Sodium oxybate, a central nervous system depressant, is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. It works by consolidating nighttime sleep and significantly reducing cataplexy episodes, thus improving daytime wakefulness.

Looking forward, the EDS pipeline reflects transformative innovation-with orexin-targeting therapies (such as TAK-861 and others) poised to reshape treatment paradigms by directly addressing orexin deficiency, a core pathophysiological driver of narcolepsy. Additionally, digital sleep monitoring tools and combination regimens are expected to personalize care further.

With increasing FDA activity, late-stage clinical trials, and investment in sleep medicine, the EDS pipeline is transitioning from symptom management toward disease-modifying strategies, offering new hope to patients struggling with the debilitating burden of hypersomnolence.

Interested in learning more about the current treatment landscape and the key drivers shaping the Excessive Daytime Sleepiness pipeline? Click here [https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Key Takeaways from the Excessive Daytime Sleepiness Pipeline Report

- DelveInsight's excessive daytime sleepiness pipeline analysis depicts a strong space with 10+ active players working to develop 12+ pipeline drugs for excessive daytime sleepiness treatment.

- The leading excessive daytime sleepiness companies include Suven Life Sciences Limited, NLS Pharmaceutics, Axsome Therapeutics, Zevra Therapeutics, Jazz Pharmaceuticals, and others are evaluating their lead assets to improve the excessive daytime sleepiness treatment landscape.

- Key excessive daytime sleepiness pipeline therapies in various stages of development include SUVN-G3031, Mazindol extended release, AXS-12, KP1077, JZP441, and others.

- In September 2025, Amneal Pharmaceuticals announced FDA approval of its sodium oxybate oral solution 500 mg/mL, an Abbreviated New Drug Application (ANDA) referencing Jazz Pharmaceuticals' Xyrem Registered . Previously, Amneal distributed an authorized generic of sodium oxybate in limited quantities. The solution is a CNS depressant used to treat cataplexy and excessive daytime sleepiness in narcolepsy patients, helping consolidate nighttime sleep and reduce cataplexy episodes, making it a standard treatment for the condition.

- In June 2025, Jazz Pharmaceuticals presented late-breaking Phase 4 data on XYWAV (low-sodium oxybate) at SLEEP 2025, highlighting its benefits for narcolepsy patients aged 7 and older, and adults with idiopathic hypersomnia. Xywav is FDA-approved for cataplexy and excessive daytime sleepiness, with a recommended nightly dose of 6-9 grams.

Excessive Daytime Sleepiness Overview

Excessive Daytime Sleepiness is a condition characterized by an overwhelming feeling of fatigue and the inability to stay awake during the day, despite having adequate sleep at night. It can result from various factors, including sleep disorders like narcolepsy, sleep apnea, or insomnia, as well as lifestyle factors, medications, or underlying health conditions. EDS significantly impacts daily functioning, leading to difficulties in concentration, memory, and productivity. Treatment often involves addressing the underlying cause, improving sleep quality, and sometimes using medications to help manage symptoms and improve wakefulness during the day.

Find out more about Excessive Daytime Sleepiness medication at https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight [https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Excessive Daytime Sleepiness Treatment Analysis: Drug Profile

AXS-12: Axsome Therapeutics

AXS-12 (reboxetine) is a highly selective norepinephrine reuptake inhibitor being developed for narcolepsy treatment. It works by modulating noradrenergic activity to promote wakefulness, maintain muscle tone, and improve cognition. Reboxetine has a strong safety record in Europe and over 40 other countries, where it is approved for depression treatment. AXS-12 is supported by positive preclinical and Phase II results and is currently in Phase III trials for treating excessive daytime sleepiness.

ALKS 2680: Alkermes

ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for narcolepsy. Orexin neuropeptides play a crucial role in regulating the sleep/wake cycle, and their loss leads to excessive daytime sleepiness and cataplexy in narcolepsy. ALKS 2680 targets the underlying pathology of narcolepsy to improve wakefulness and control cataplexy. It is currently undergoing Phase II trials for idiopathic hypersomnia, with once-daily oral administration.

Learn more about the novel and emerging excessive daytime sleepiness pipeline therapies [https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].

Excessive Daytime Sleepiness Therapeutics Assessment

By Product Type

- Mono

- Combination

- Mono/Combination.

By Stage

- Late-stage products (Phase III)

- Mid-stage products (Phase II)

- Early-stage product (Phase I) along with the details of

- Pre-clinical and Discovery stage candidates

- Discontinued & Inactive candidates

By Route of Administration

- Oral

- Intravenous

- Subcutaneous

- Parenteral

- Topical

By Molecule Type

- Monoclonal Antibody

- Peptides

- Polymer

- Small molecule

Scope of the Excessive Daytime Sleepiness Pipeline Report

- Coverage: Global

- Key Excessive Daytime Sleepiness Companies: Suven Life Sciences Limited, NLS Pharmaceutics, Axsome Therapeutics, Zevra Therapeutics, Jazz Pharmaceuticals, and others.

- Key Excessive Daytime Sleepiness Pipeline Therapies: SUVN-G3031, Mazindol extended release, AXS-12, KP1077, JZP441, and others.

Explore detailed insights on drugs used in the treatment of excessive daytime sleepiness here [https://www.delveinsight.com/report-store/excessive-daytime-sleepiness-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].

Table of Contents

1. Introduction

2. Executive Summary

3. Excessive Daytime Sleepiness Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. Excessive Daytime Sleepiness Pipeline Therapeutics

6. Excessive Daytime Sleepiness Pipeline: Late-Stage Products (Phase III)

7. Excessive Daytime Sleepiness Pipeline: Mid-Stage Products (Phase II)

8. Excessive Daytime Sleepiness Pipeline: Early Stage Products (Phase I)

9. Therapeutic Assessment

10. Inactive Products

11. Company-University Collaborations (Licensing/Partnering) Analysis

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

About DelveInsight

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