Insomnia

22
Pipeline Programs
11
Companies
32
Clinical Trials
1 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
0
0
8
9
Early DiscoveryClinical DevelopmentMarket

On Market (4)

Approved therapies currently available

M&
BELSOMRAApproved
suvorexant
Merck & Co.
Orexin Receptor Antagonist [EPC]oral2014
E
DAYVIGOApproved
lemborexant
Eisai
Orexin Receptor Antagonist [EPC]oral2019
U
RAMELTEONApproved
ramelteon
Unknown Company
Melatonin Receptor Agonist [EPC]oral2020
Takeda
ROZEREMApproved
ramelteon
Takeda
Melatonin Receptor Agonist [EPC]oral2005

Competitive Landscape

11 companies ranked by most advanced pipeline stage

E
EisaiChina - Liaoning
9 programs
3
3
1
LemborexantPhase 41 trial
Eszopiclone 1 mg- ElderlyPhase 31 trial
LEM 5 mgPhase 31 trial
LemborexantPhase 31 trial
E2006Phase 11 trial
+4 more programs
Active Trials
NCT02452684Completed4,876Est. Dec 2015
NCT02455271Completed438Est. Dec 2015
NCT01673880Completed40Est. Dec 2012
+6 more trials
Takeda
TakedaTOKYO, Japan
5 programs
2
2
RamelteonPhase 41 trial
Ramelteon, zolpidem and placeboPhase 41 trial
RamelteonPhase 31 trial
RamelteonPhase 31 trial
RamelteonN/A1 trial
Active Trials
NCT02058992Completed3,339Est. Apr 2013
NCT00656994Completed122Est. Jul 2004
NCT00869167Terminated2Est. Jun 2009
+2 more trials
M&
Merck & Co.RAHWAY, NJ
4 programs
2
1
EsmirtazapinePhase 31 trial
SuvorexantPhase 33 trials
Multiple Sleep Latency TestN/A1 trial
SleepLife Application w/FitBitN/A1 trial
Active Trials
NCT02290405Completed89Est. Dec 2017
NCT03795129Unknown200Est. Feb 2019
NCT00482612Completed526Est. Aug 2008
+3 more trials
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
Solriamfetol 75 MGPhase 41 trial
Active Trials
NCT05838430Active Not Recruiting60Est. Apr 2026
Astellas
AstellasChina - Shenyang
1 program
1
zolpidemPhase 41 trial
Active Trials
NCT00653562Completed11Est. Mar 2010
VP
Vanda PharmaceuticalsWASHINGTON, DC
1 program
1
20 mg VEC-162Phase 31 trial
Active Trials
NCT00291187Completed411Est. Aug 2006
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
LY2624803Phase 15 trials
Active Trials
NCT01257178Terminated0Est. Nov 2010
NCT01236105Completed21Est. Dec 2010
NCT01784614Completed24Est. Mar 2010
+2 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
PD 0200390Phase 11 trial
Active Trials
NCT00722306Completed6Est. May 2008
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
Sleep hygiene adviceN/A1 trial
Active Trials
NCT04585425Completed60Est. Jun 2023
Closed Loop Medicine
Closed Loop MedicineUK - Cambridge
1 program
Stage 2 Digital sleep diary appN/A1 trial
Active Trials
NCT05093426CompletedEst. Aug 2022
Ipsen
IpsenChina - Tianjin
1 program
The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or OverN/A1 trial
Active Trials
NCT02321449Completed40Est. Feb 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Axsome TherapeuticsSolriamfetol 75 MG
EisaiLemborexant
TakedaRamelteon
Astellaszolpidem
TakedaRamelteon, zolpidem and placebo
Merck & Co.Suvorexant
EisaiLEM 5 mg
EisaiLemborexant
EisaiEszopiclone 1 mg- Elderly
TakedaRamelteon
Merck & Co.Esmirtazapine
Vanda Pharmaceuticals20 mg VEC-162
TakedaRamelteon
Eli Lilly and CompanyLY2624803
EisaiE2006

Showing 15 of 32 trials with date data

Clinical Trials (32)

Total enrollment: 13,020 patients across 32 trials

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Start: Jul 2023Est. completion: Apr 202660 patients
Phase 4Active Not Recruiting
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

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

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

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
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

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

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

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

Start: Feb 2006Est. completion: Aug 2006411 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

An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia

Start: Oct 2008Est. completion: Feb 2010643 patients
Phase 2Completed

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

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

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

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

Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

Start: Feb 2010Est. completion: Apr 201016 patients
Phase 1Completed
NCT01055834EisaiEszopiclone 3 mg

A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)

Start: Jan 2010Est. completion: Feb 201042 patients
Phase 1Completed

A Study of LY2624803 in Japanese Participants With Transient Insomnia

Start: Sep 2009Est. completion: Mar 201024 patients
Phase 1Completed

A Study of LY2624803 in Participants With Transient Insomnia

Start: May 2008Est. completion: Nov 200832 patients
Phase 1Completed

A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Start: May 2008Est. completion: May 20086 patients
Phase 1Completed
NCT05093426Closed Loop MedicineStage 2 Digital sleep diary app

PERSONAL - Sleep In Breast Cancer

Start: Jan 2022Est. completion: Aug 2022
N/ACompleted
NCT04585425Heidelberg PharmaSleep hygiene advice

Music for Sleep-onset Insomnia

Start: May 2021Est. completion: Jun 202360 patients
N/ACompleted
NCT03795129Merck & Co.SleepLife Application w/FitBit

Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication

Start: Jun 2018Est. completion: Feb 2019200 patients
N/AUnknown
NCT02290405Merck & Co.Multiple Sleep Latency Test

Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers

Start: Oct 2014Est. completion: Dec 201789 patients
N/ACompleted
NCT02321449IpsenThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Start: Jun 2014Est. completion: Feb 201540 patients
N/ACompleted
NCT02455271EisaiEszopiclone

Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

Start: Oct 2012Est. completion: Dec 2015438 patients
N/ACompleted
NCT02452684EisaiEszopiclone

Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Start: Oct 2012Est. completion: Dec 20154,876 patients
N/ACompleted

Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Start: Jul 2010Est. completion: Apr 20133,339 patients
N/ACompleted

Phase Legend

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

Key Insights

8 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 13,020 patients
11 companies competing in this space