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Insomnia Disorder

10
Pipeline Programs
6
Companies
16
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
2
3
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Idorsia
QUVIVIQApproved
daridorexant
Idorsia
Orexin Receptor Antagonist [EPC]oral2022
16M Part D

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Idorsia
IdorsiaSwitzerland - Allschwil
8 programs
3
3
1
DaridorexantPhase 41 trial
DaridorexantPhase 31 trial
Daridorexant 10 mgPhase 31 trial
Daridorexant 25 mgPhase 31 trial
ACT-541468Phase 21 trial
+3 more programs
Active Trials
NCT07532252Not Yet Recruiting150Est. Feb 2031
NCT07555743Not Yet Recruiting134Est. Oct 2028
NCT06393504Active Not Recruiting2,095Est. Apr 2028
+7 more trials
Ache Laboratorios Farmaceuticos
1 program
1
MelatoninPhase 2/31 trial
Active Trials
NCT02798367Unknown307Est. Nov 2021
Biolab Pharma
Biolab PharmaBrazil - São Paulo
1 program
1
ZolpidemPhase 2/31 trial
Active Trials
NCT03885141Unknown366Est. Dec 2021
Eisai
EisaiChina - Liaoning
2 programs
Lemborexant 5 mgPHASE_11 trial
lemborexantPHASE_31 trial
Active Trials
NCT02350309Completed69Est. Apr 2015
NCT02952820Completed971Est. Jan 2019
Nxera Pharma
Nxera PharmaJapan - Tokyo
1 program
DaridorexantPHASE_31 trial
Active Trials
NCT07028697Completed164Est. Oct 2025
Vanda Pharmaceuticals
Vanda PharmaceuticalsWASHINGTON, DC
1 program
Tasimelteon Oral SuspensionPHASE_31 trial
Active Trials
NCT06953869Recruiting420Est. Jan 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
IdorsiaDaridorexant
IdorsiaDaridorexant
Vanda PharmaceuticalsTasimelteon Oral Suspension
Nxera PharmaDaridorexant
IdorsiaDaridorexant 10 mg
IdorsiaDaridorexant 25 mg
IdorsiaDaridorexant
Eisailemborexant
Biolab PharmaZolpidem
Ache Laboratorios FarmaceuticosMelatonin
IdorsiaDaridorexant
IdorsiaZolpidem
IdorsiaACT-541468
IdorsiaACT-541468 5 mg
EisaiLemborexant 5 mg

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 7,925 patients across 16 trials

NCT07555743IdorsiaDaridorexant

Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia

Start: Apr 2026Est. completion: Oct 2028134 patients
Phase 4Not Yet Recruiting
NCT05597020IdorsiaDaridorexant

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Start: Feb 2023Est. completion: Apr 202460 patients
Phase 4Completed
NCT06953869Vanda PharmaceuticalsTasimelteon Oral Suspension

Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Start: Apr 2025Est. completion: Jan 2028420 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Start: Dec 2024Est. completion: Oct 2025164 patients
Phase 3Completed
NCT03679884IdorsiaDaridorexant 10 mg

Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Start: Oct 2018Est. completion: Feb 2021804 patients
Phase 3Completed
NCT03545191IdorsiaDaridorexant 25 mg

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Start: Jun 2018Est. completion: Feb 2020930 patients
Phase 3Completed
NCT03575104IdorsiaDaridorexant

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Start: May 2018Est. completion: May 2020924 patients
Phase 3Completed
NCT02952820Eisailemborexant

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

Start: Nov 2016Est. completion: Jan 2019971 patients
Phase 3Completed

Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.

Start: Mar 2021Est. completion: Dec 2021366 patients
Phase 2/3Unknown

Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia

Start: Mar 2018Est. completion: Nov 2021307 patients
Phase 2/3Unknown
NCT07532252IdorsiaDaridorexant

Daridorexant for Alcohol Use Disorder

Start: Jan 2027Est. completion: Feb 2031150 patients
Phase 2Not Yet Recruiting

Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder

Start: Feb 2017Est. completion: May 2017113 patients
Phase 2Completed

Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder

Start: Nov 2016Est. completion: Jun 201758 patients
Phase 2Completed
NCT02839200IdorsiaACT-541468 5 mg

Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

Start: Oct 2016Est. completion: Jun 2017360 patients
Phase 2Completed
NCT02350309EisaiLemborexant 5 mg

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

Start: Dec 2014Est. completion: Apr 201569 patients
Phase 1Completed
NCT06393504IdorsiaDaridorexant

Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Start: Nov 2023Est. completion: Apr 20282,095 patients
N/AActive Not Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 7,925 patients
6 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.