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Disease

Sleepiness

Late-stage therapeutic developmentEmerging research
MeSHSleepiness
1
Publications
14
Clinical trials
2023
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 2 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
Clinical Milestones4View
Results posted 1
Results expected 2
Recently completed 1
Activity timeline4

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Pitolisantapproved

Approval — Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS)… (2021)

Solriamfetol hydrochlorideapproved

Approval — Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adu… (2020)

Clinical trials

10 sponsors · 1 new · 0 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
14
All trials
3
Active
10
Late-stage
6
Completed
Late-stage studies

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Phase 3 · Completed · Axsome Therapeutics, Inc.

A Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Treatment with Solriamfetol in Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea Syndrome (OSA) with a 12-week Treatment Period

Phase 3 · Completed · Ignis Therapeutics (Suzhou) Limited

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea

Phase 3 · Completed · Citrine Medicine Limited

A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

Phase 2/3 · Completed · Duke University
Recruiting

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

Phase 3 · Recruiting · Axsome Therapeutics, Inc.

A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects

Phase 1 · Recruiting · Centessa Pharmaceuticals (UK) Limited
Recently completed

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Phase 3 · Completed · Axsome Therapeutics, Inc.

A Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Treatment with Solriamfetol in Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea Syndrome (OSA) with a 12-week Treatment Period

Phase 3 · Completed · Ignis Therapeutics (Suzhou) Limited

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea

Phase 3 · Completed · Citrine Medicine Limited

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function

Phase 4 · Completed · Axsome Therapeutics, Inc.

A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

Phase 2/3 · Completed · Duke University

Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

Phase 3 · Completed · Bioprojet

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2021emaApproval — Pitolisant· Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) source ↗
2020emaApproval — Solriamfetol hydrochloride· Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Major themes1
  • Sleep Initiation and Maintenance Disorders1
Leading journals1
  • BMC public health1
Leading researchers6
  • Ahuja A1
  • Büsser A1
  • Freidank M1
  • Grandner M1
  • McCall WV1
  • Olivieri A1
Affiliations (unnormalised)2
  • Medical College of Georgia at Augusta University1
  • University of Arizona College of Medicine1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Compelling urge to sleep.

Identifiers
MeSHSleepiness
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.