Which excessive daytime sleepiness drugs are in Phase 3?

Phase 3 (or later) programs for excessive daytime sleepiness include Solriamfetol (Sunosi).

What are the next excessive daytime sleepiness trial readouts?

Upcoming catalysts include Solriamfetol (Sunosi) (2027).

How many clinical trials are recruiting for excessive daytime sleepiness?

12 drug-interventional excessive daytime sleepiness trials are currently recruiting participants, out of 57 registered interventional trials.

Sleep-Wake Disorders

Excessive daytime sleepiness drug pipeline

MeSH D006970

1 compound from 1 company is in active clinical development for excessive daytime sleepiness, including 1 at Phase 3 or beyond.

1Compound

1Company

1Phase 3+

1Upcoming readout

12Trials recruiting

Phase 3 1

Mechanisms: Small molecule (1)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2027AnticipatedSolriamfetol (Sunosi)Topline datapendingNCT06568367
SUSTAIN Phase 3 (solriamfetol for excessive sleepiness in shift work disorder) topline anticipated in 2027. ↗

See the full catalyst calendar →

Compounds in development (1)

Compound	Company	Phase	Status	Mechanism
Solriamfetol (Sunosi)	Axsome Therapeutics, Inc.	Phase 3	Recruiting	NET Reuptake inhibitor

Trials recruiting now (12)

12 drug-interventional excessive daytime sleepiness trials recruiting now, of 57 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 3A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
Samelisant, Placebo
Suven Life Sciences Limitedn=240Started Jun 2026NCT07540364
Phase 3A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo
Alkermes, Inc.n=150United States · 5 sitesStarted Jun 2026NCT07540897
Phase 3A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3, Placebo
Alkermes, Inc.n=176Canada, United States · 15 sitesStarted Apr 2026NCT07502443
Phase 3A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 302)
ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo
Alkermes plcn=150Canada, United States · 17 sitesStarted Apr 2026Tracked: Alixorexton NCT07455383
Phase 3A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
HBS-301 tablet, Placebo
Harmony Biosciences Management, Inc.n=248United States · 12 sitesStarted Mar 2026NCT07500090
Phase 3A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms (CLARITY)
Solriamfetol 150 MG, Placebo
Axsome Therapeutics, Inc.n=508United States · 13 sitesStarted Feb 2026Tracked: Solriamfetol (Sunosi)NCT07484217
Phase 3A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder (SUSTAIN)
Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
Axsome Therapeutics, Inc.n=520Canada, United States · 40 sitesStarted Aug 2024Tracked: Solriamfetol (Sunosi)NCT06568367
Phase 2/3A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
cleminorexton, Placebo
Centessa Pharmaceuticals (UK) Limitedn=222United States · 2 sitesStarted May 2026NCT07598708
Phase 2/3A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg, ALKS 2680, 18mg
Alkermes, Inc.n=256Australia, Belgium +6 · 46 sitesStarted Jan 2025NCT06767683
Phase 2A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
ORX750
Centessa Pharmaceuticals (UK) Limitedn=90Canada, Italy +2 · 24 sitesStarted Aug 2025NCT07096674
Phase 2A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
ALKS 2680, Placebo
Alkermes plcn=126Australia, Belgium +6 · 50 sitesStarted May 2025Tracked: Alixorexton NCT06843590
Phase 1A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
ORX142 Tablets
Centessa Pharmaceuticals (UK) Limitedn=208United States · 3 sitesStarted Jun 2025NCT07082829

Frequently asked

How many drugs are in development for excessive daytime sleepiness?: 1 compound from 1 company is in active clinical development for excessive daytime sleepiness, including 1 at Phase 3 or beyond.
Which excessive daytime sleepiness drugs are in Phase 3?: Phase 3 (or later) programs for excessive daytime sleepiness include Solriamfetol (Sunosi).
What are the next excessive daytime sleepiness trial readouts?: Upcoming catalysts include Solriamfetol (Sunosi) (2027).
How many clinical trials are recruiting for excessive daytime sleepiness?: 12 drug-interventional excessive daytime sleepiness trials are currently recruiting participants, out of 57 registered interventional trials.