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Insomnia

58
Pipeline Programs
30
Companies
50
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
16
1
9
0
20
12
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Merck & Co.
BELSOMRAApproved
suvorexant
Merck & Co.
Orexin Receptor Antagonist [EPC]oral2014
161M Part D

Competitive Landscape

45 companies ranked by most advanced pipeline stage

Sharp Therapeutics
4
6
4
SuvorexantPhase 4
SuvorexantPhase 4
Suvorexant 20 mgPhase 4
suvorexantPhase 4
EsmirtazapinePhase 3
+11 more programs
MSD
MSDIreland - Ballydine
16 programs
4
6
4
SuvorexantPhase 41 trial
SuvorexantPhase 41 trial
Suvorexant 20 mgPhase 41 trial
suvorexantPhase 41 trial
EsmirtazapinePhase 31 trial
+11 more programs
Active Trials
NCT02290405Completed89Est. Dec 2017
NCT03795129Unknown200Est. Feb 2019
NCT01311882Completed28Est. Nov 2011
+13 more trials
Merck & Co.
Merck & Co.RAHWAY, NJ
4 programs
1
Multiple Sleep Latency TestN/A
SleepLife Application w/FitBitN/A
EsmirtazapinePHASE_3
SuvorexantPHASE_3
Astellas
AstellasChina - Shenyang
2 programs
2
ZolpidemPhase 41 trial
zolpidemPhase 41 trial
Active Trials
NCT00432198Completed122Est. Jan 2010
NCT00653562Completed11Est. Mar 2010
Pharmanovia
1 program
1
Chloral HydratePhase 41 trial
Active Trials
NCT06053840Completed100Est. May 2024
Lundbeck
LundbeckDenmark - Copenhagen
6 programs
1
5
MK0928, gaboxadolPhase 31 trial
MK0928, gaboxadol / Duration of Treatment - 1 yearPhase 31 trial
MK0928, gaboxadol / Duration of Treatment: 10 monthsPhase 31 trial
gaboxadolPhase 31 trial
gaboxadolPhase 31 trial
+1 more programs
Active Trials
NCT00940550Completed16Est. Aug 2009
NCT00095043Completed320
NCT00095069Completed600Est. Feb 2007
+3 more trials
Neurocrine Biosciences
2 programs
2
IndiplonPhase 31 trial
NBI-34060Phase 31 trial
Active Trials
NCT00232167Terminated380Est. Apr 2006
NCT00525941Withdrawn0Est. Jan 2008
Coordination Pharmaceuticals
1 program
1
AmitriptylinePhase 31 trial
Active Trials
NCT02139098Terminated23Est. Nov 2017
Idorsia
IdorsiaSwitzerland - Allschwil
3 programs
1
Daridorexant 10 mgPhase 21 trial
DaridorexantN/A
Daridorexant 50 mgN/A1 trial
Active Trials
NCT06311864Enrolling By Invitation100Est. Oct 2025
NCT05423717Completed166Est. Feb 2026
Purdue Pharma
Purdue PharmaCT - Stamford
2 programs
1
V117957 tabletsPhase 21 trial
Bedtime routineN/A1 trial
Active Trials
NCT03447665Completed30Est. Apr 2019
NCT04035200Completed114Est. Nov 2020
Innovation Pharmaceuticals
2 programs
1
Ningshen Danxiang Donkey-hide Gelatin Medicated PastePhase 21 trial
Dayzz mobile sleep trainingN/A1 trial
Active Trials
NCT03955120Completed125Est. Dec 2020
NCT07504536Not Yet Recruiting60Est. Dec 2028
Pfizer
PfizerNEW YORK, NY
2 programs
1
1
PD 0200390Phase 21 trial
PD 0200390Phase 11 trial
Active Trials
NCT00722306Completed6Est. May 2008
NCT00569972Completed682Est. Jan 2009
Apsen Farmaceutica
1
APSTZDPhase 21 trial
Active Trials
NCT07420816Not Yet Recruiting222Est. Sep 2027
EMS
EMSBrazil - Hortolândia
1 program
1
Hipnos 3Phase 21 trial
Active Trials
NCT03814135Withdrawn0Est. Mar 2022
Orion Pharma
Orion PharmaUK - Reading
1 program
1
TasipimidinePhase 21 trial
Active Trials
NCT06956495Completed190Est. Sep 2025
Orion
1 program
1
TasipimidinePhase 2
Imbrium Therapeutics
1
V117957 tabletsPhase 2
Human BioSciences
1
ZolpidemPhase 1/21 trial
Physical activity timingN/A1 trial
Sleep Parent TrainingN/A1 trial
Active Trials
NCT06613958Completed36Est. Jun 2024
NCT07435740Not Yet Recruiting180Est. Jan 2031
NCT00494468Completed63Est. Mar 2004
Sunshine Biopharma
2
FoodPhase 11 trial
HEC83518 tabletsPhase 11 trial
Active Trials
NCT04667429Unknown52Est. Oct 2021
NCT04596007Unknown70Est. Jun 2021
Prevail Therapeutics
2
LY2624803Phase 11 trial
LY2624803Phase 11 trial
Active Trials
NCT01236105Completed21Est. Dec 2010
NCT01257178Terminated0Est. Nov 2010
Neurim Pharmaceuticals
1
Neu-P11Phase 11 trial
Active Trials
NCT01114126Completed24Est. Apr 2011
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
SB-649868Phase 1
Eisai
EisaiChina - Liaoning
9 programs
EszopicloneN/A1 trial
EszopicloneN/A1 trial
E2006PHASE_11 trial
E2006 1.0 mgPHASE_11 trial
Eszopiclone 3 mgPHASE_11 trial
+4 more programs
Active Trials
NCT02455271Completed438Est. Dec 2015
NCT02452684Completed4,876Est. Dec 2015
NCT01673880Completed40Est. Dec 2012
+6 more trials
Takeda
TakedaTOKYO, Japan
5 programs
RamelteonN/A1 trial
RamelteonPHASE_31 trial
RamelteonPHASE_31 trial
RamelteonPHASE_45 trials
Ramelteon, zolpidem and placeboPHASE_41 trial
Active Trials
NCT02058992Completed3,339Est. Apr 2013
NCT00656994Completed122Est. Jul 2004
NCT00869167Terminated2Est. Jun 2009
+6 more trials
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
3 programs
Computerized Cognitive Behavioral Therapy for InsomniaN/A1 trial
Computerized Cognitive Behavioral Therapy for InsomniaN/A1 trial
Computerized Cognitive Behavioral Therapy for InsomniaN/A1 trial
Active Trials
NCT03365024Completed93Est. Jul 2019
NCT05683145Recruiting80Est. May 2026
NCT03366870Completed250Est. Jun 2020
ResMed
ResMedSAN DIEGO, CA
2 programs
ASV therapyN/A1 trial
AirCurve 10 ASVN/A1 trial
Active Trials
NCT07011966Not Yet Recruiting25Est. Aug 2026
NCT02365064Completed78Est. Dec 2017
Angeles Therapeutics
Digital cognitive-behavioral therapy for insomniaN/A1 trial
Sleep Healthy Using The InternetN/A1 trial
Active Trials
NCT04308499Terminated24Est. Feb 2024
NCT06041581Enrolling By Invitation200Est. Jul 2027
Medica Corp
Medica CorpMA - Bedford
2 programs
Non-pharmacological approach of insomniaN/A1 trial
cyclamaxN/A1 trial
Active Trials
NCT01091987Completed45Est. Jun 2011
NCT00484497Completed105
Neurovalens
NeurovalensUK - Belfast
2 programs
VeNSN/A1 trial
VeNSN/A1 trial
Active Trials
NCT04219566Completed80Est. Jul 2022
NCT04452981Completed153Est. Jan 2023
IQVIA
IQVIADURHAM, NC
1 program
DaridorexantN/A1 trial
Active Trials
NCT06498128Recruiting785Est. Mar 2033

+15 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
PharmanoviaChloral Hydrate
TakedaRamelteon
EisaiLemborexant
MSDSuvorexant 20 mg
TakedaRamelteon
MSDsuvorexant
MSDSuvorexant
MSDSuvorexant
AstellasZolpidem
Astellaszolpidem
TakedaRamelteon, zolpidem and placebo
MSDSuvorexant
EisaiLEM 5 mg
EisaiLemborexant
Coordination PharmaceuticalsAmitriptyline

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 11,484 patients across 50 trials

NCT06053840PharmanoviaChloral Hydrate

An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia

Start: Sep 2023Est. completion: May 2024100 patients
Phase 4Completed

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

Start: May 2022Est. completion: Sep 20225 patients
Phase 4Terminated
NCT04742699EisaiLemborexant

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

Start: Mar 2021Est. completion: Jun 202297 patients
Phase 4Completed
NCT04092894MSDSuvorexant 20 mg

Suvorexant and Sleep/Delirium in ICU Patients

Start: Feb 2020Est. completion: Jul 2025100 patients
Phase 4Completed

The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy

Start: May 2017Est. completion: Jan 201826 patients
Phase 4Completed
NCT02704754MSDsuvorexant

Suvorexant and Trauma Related Insomnia

Start: May 2016Est. completion: Apr 202141 patients
Phase 4Completed
NCT02729714MSDSuvorexant

A Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Start: Apr 2016Est. completion: Apr 202221 patients
Phase 4Completed
NCT02527564MSDSuvorexant

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Start: Sep 2015Est. completion: Mar 202161 patients
Phase 4Completed

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Start: Feb 2007Est. completion: Jan 2010122 patients
Phase 4Completed

Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Start: Nov 2006Est. completion: Mar 201011 patients
Phase 4Completed
NCT00568789TakedaRamelteon, zolpidem and placebo

Safety of Ramelteon in Elderly Subjects

Start: Jun 2006Est. completion: Sep 200633 patients
Phase 4Completed
NCT06655883MSDSuvorexant

A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Start: Oct 2025Est. completion: Jun 2027300 patients
Phase 3Recruiting

A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

Start: Jul 2019Est. completion: Jun 202053 patients
Phase 3Completed
NCT02783729EisaiLemborexant

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Start: May 2016Est. completion: Jan 20181,006 patients
Phase 3Completed

Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

Start: May 2014Est. completion: Nov 201723 patients
Phase 3Terminated
NCT01021813MSDSuvorexant

A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

Start: Dec 2009Est. completion: Aug 2011781 patients
Phase 3Completed
NCT00770692EisaiEszopiclone 1 mg- Elderly

A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)

Start: Oct 2008Est. completion: May 2010369 patients
Phase 3Completed

Ramelteon for Insomnia Comorbid With Asthma

Start: Mar 2008Est. completion: Jun 20092 patients
Phase 3Terminated
NCT00561821MSDEsmirtazapine

Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)

Start: Nov 2007Est. completion: Dec 2009538 patients
Phase 3Completed

An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

Start: Sep 2007Est. completion: Jan 20080
Phase 3Withdrawn
NCT00506389MSDEsmirtazapine

A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Start: Jun 2007Est. completion: Feb 2008419 patients
Phase 3Completed
NCT00482612MSDEsmirtazapine

Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

Start: Dec 2006Est. completion: Aug 2008526 patients
Phase 3Completed

Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

Start: Dec 2006Est. completion: Aug 2009346 patients
Phase 3Completed

VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

Start: Feb 2006Est. completion: Aug 2006411 patients
Phase 3Completed

Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression

Start: Nov 2005Est. completion: Apr 2006380 patients
Phase 3Terminated

Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

Start: Feb 2005Est. completion: Dec 2005663 patients
Phase 3Completed

An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

Start: Feb 2005Est. completion: Oct 2006900 patients
Phase 3Completed
NCT00102154LundbeckMK0928, gaboxadol / Duration of Treatment: 10 months

An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

Start: Jan 20050
Phase 3Withdrawn
NCT00095043LundbeckMK0928, gaboxadol

Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)

Start: Oct 2004320 patients
Phase 3Completed
NCT00095069LundbeckMK0928, gaboxadol / Duration of Treatment - 1 year

Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

Start: Oct 2004Est. completion: Feb 2007600 patients
Phase 3Completed

Efficacy of Ramelteon in Subjects With Chronic Insomnia

Start: Feb 2003Est. completion: Sep 20041,213 patients
Phase 3Completed

Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

Start: Jan 2003Est. completion: Jul 2004122 patients
Phase 3Completed

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Start: Mar 2026Est. completion: Sep 2027222 patients
Phase 2Not Yet Recruiting
NCT07504536Innovation PharmaceuticalsNingshen Danxiang Donkey-hide Gelatin Medicated Paste

Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia

Start: Mar 2026Est. completion: Dec 202860 patients
Phase 2Not Yet Recruiting

Efficacy and Tolerability of Tasipimidine in Sleepless Patients

Start: Aug 2023Est. completion: Sep 2025190 patients
Phase 2Completed
NCT05423717IdorsiaDaridorexant 10 mg

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

Start: Sep 2022Est. completion: Feb 2026166 patients
Phase 2Completed

Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

Start: Jan 2021Est. completion: Mar 20220
Phase 2Withdrawn

Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation

Start: Sep 2019Est. completion: Nov 2020114 patients
Phase 2Completed

A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Start: Oct 2007Est. completion: Jan 2009682 patients
Phase 2Completed

Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children

Start: Oct 2002Est. completion: Mar 200463 patients
Phase 1/2Completed

the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

Start: Jan 2021Est. completion: Oct 202152 patients
Phase 1Unknown

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Start: Apr 2020Est. completion: Jun 202170 patients
Phase 1Unknown

Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

Start: Aug 2012Est. completion: Dec 201240 patients
Phase 1Completed
NCT01463098EisaiE2006 1.0 mg

A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Start: Oct 2011Est. completion: Aug 2012122 patients
Phase 1Completed
NCT01311882MSDMK-4305 40 mg

A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)

Start: Apr 2011Est. completion: Nov 201128 patients
Phase 1Completed
NCT01293006MSDsuvorexant

Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)

Start: Mar 2011Est. completion: Feb 201225 patients
Phase 1Completed

A Study to Evaluate the Pharmacokinetics of LY2624803 in Subjects With Hepatic Impairment

Start: Nov 2010Est. completion: Nov 20100
Phase 1Terminated

Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject

Start: Oct 2010Est. completion: Dec 201021 patients
Phase 1Completed
NCT01059851MSDSuvorexant

Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)

Start: May 2010Est. completion: Jul 201016 patients
Phase 1Completed

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

Start: Apr 2010Est. completion: Apr 201124 patients
Phase 1Completed

Phase Legend

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

Key Insights

20 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 11,484 patients
30 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.