Which insomnia drugs are in Phase 3?

Phase 3 (or later) programs for insomnia include Vornorexant (TS-142).

How many clinical trials are recruiting for insomnia?

50 drug-interventional insomnia trials are currently recruiting participants, out of 427 registered interventional trials.

Sleep-Wake Disorders

Insomnia drug pipeline

ICD-11 7A00
MeSH D007319

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

1Compound

1Company

1Phase 3+

50Trials recruiting

Approved 1

Mechanisms: Small molecule (1)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2025-08-25ReportedVornorexant (TS-142)Regulatorymet
Japan MHLW approved Vorzzz (vornorexant hydrate) 2.5/5/10 mg for insomnia. ↗
2025-06-28ReportedVornorexant (TS-142)Full resultsmetNCT05453136
Pivotal Phase 3 TS142-301 met primary (sSL) and key secondary (sSE) endpoints at both 5 mg and 10 mg (p<0.001). ↗

See the full catalyst calendar →

Compounds in development (1)

Compound	Company	Phase	Status	Mechanism
Vornorexant (TS-142)	OOTEMON Co., Ltd.	Approved	Approved	OX2 receptor Antagonist

Trials recruiting now (50)

50 drug-interventional insomnia trials recruiting now, of 427 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Lemborexant, placebo
YangPann=44China · 1 siteStarted Aug 2026NCT07384429
Phase 4The Effects of Orexin Antagonism on Fear Extinction in PTSD
Suvorexant, Placebo
VA Office of Research and Developmentn=40,120United States · 2 sitesStarted Jun 2026NCT06788522
Phase 4A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
Diphenhydramine, 25 mg, Diphenhydramine, 50 mg, Doxepin, 3 mg, Doxepin, 6 mg, Trazodone, 50 mg, Trazodone, 100 mg, Placebo, Zolpidem, 5 mg, Zolpidem, 10 mg
University of Pennsylvanian=1,200United States · 1 siteStarted May 2026NCT07542756
Phase 4Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
Daridorexant 50 mg, Placebo
Institut d'Investigació Biomèdica de Bellvitgen=134Spain · 1 siteStarted Apr 2026NCT07555743
Phase 4Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
Trazodone, Daridorexant
Brigham and Women's Hospitaln=1,000United States · 5 sitesStarted Feb 2026NCT07136415
Phase 4Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
Daridorexant 50 mg
Legacy Health Systemn=44United States · 1 siteStarted Feb 2026NCT07328594
Phase 4Compound Ciwujia Granules in the Treatment of Insomnia
Compound Ciwujia Granules group, Estazolam, Compound Ciwujia Granules and estazolam
Hui Zhun=1,200Started Jan 2026NCT07306494
Phase 4No More Sleepless Nights in Perimenopause
Hormone Replacement Therapy (HRT)
Insel Gruppe AG, University Hospital Bernn=54Switzerland · 1 siteStarted Jan 2026NCT06497894
Phase 4Sleeping Through Menopause
Estrogens and Progestogens
VU University of Amsterdamn=222Started Oct 2025NCT06306404
Phase 4Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.
Dolutegravir (DTG), Darunavir/Cobicistat (FDC)
Instituto Mexicano del Seguro Socialn=140Started Jun 2025NCT06787976
Phase 4Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Eszopiclone 3 mg, Placebo
University of Sao Paulon=150Brazil · 1 siteStarted Jun 2025NCT07018557
Phase 4Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
Daridorexant 50 mg, Placebo
University Hospital, Montpelliern=62France · 1 siteStarted Mar 2024NCT05924425

Showing the 12 most advanced of 50 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for insomnia?: 1 compound from 1 company is in active clinical development for insomnia, including 1 at Phase 3 or beyond.
Which insomnia drugs are in Phase 3?: Phase 3 (or later) programs for insomnia include Vornorexant (TS-142).
How many clinical trials are recruiting for insomnia?: 50 drug-interventional insomnia trials are currently recruiting participants, out of 427 registered interventional trials.