Sleep Initiation and Maintenance Disorders

24
Pipeline Programs
8
Companies
29
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
6
0
13
3
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

E
DAYVIGOApproved
lemborexant
Eisai
Orexin Receptor Antagonist [EPC]oral2019

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
4 programs
2
2
Zolpidem MRPhase 41 trial
Zolpidem MRPhase 41 trial
FK199BPhase 31 trial
zolpidem MRPhase 32 trials
Active Trials
NCT00999219Completed55Est. Jul 2007
NCT00374777Completed450Est. Jun 2008
NCT00283946Completed876Est. Nov 2007
+2 more trials
E
EisaiChina - Liaoning
3 programs
1
1
1
LemborexantPhase 31 trial
LemborexantPhase 21 trial
LemborexantN/A1 trial
Active Trials
NCT04573556Completed550Est. Mar 2022
NCT05594589Completed65Est. May 2024
NCT04549168Completed194Est. Mar 2023
Sanofi
SanofiPARIS, France
6 programs
6
VolinanserinPhase 32 trials
eplivanserinPhase 31 trial
volinanserinPhase 31 trial
volinanserinPhase 31 trial
zolpidem-MRPhase 31 trial
+1 more programs
Active Trials
NCT00788515Terminated33Est. Jan 2009
NCT00464061Terminated1,847Est. Mar 2009
NCT00679900Completed283Est. Mar 2009
+4 more trials
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
4 programs
3
BrotizolamPhase 31 trial
Eschscholtzia CalifornicaPhase 31 trial
Songha Night ®Phase 31 trial
Lendormin D tabletsN/A1 trial
Active Trials
NCT02224014Completed485
NCT00347295Completed253Est. Jan 2007
NCT02183233Terminated49
+1 more trials
M&
Merck & Co.RAHWAY, NJ
2 programs
1
esmirtazapinePhase 31 trial
Night in Japan Home Sleep Monitoring StudyN/A1 trial
Active Trials
NCT03276585Unknown2,000Est. Aug 2019
NCT00750919Terminated184Est. Mar 2010
GSK
GSKLONDON, United Kingdom
6 programs
2
4
GR205171Phase 21 trial
GW679769Phase 21 trial
GW679769Phase 21 trial
GW679769Phase 21 trial
14C-SB649868Phase 11 trial
+1 more programs
Active Trials
NCT00520663Completed8Est. Aug 2007
NCT00495274Completed16Est. Sep 2007
NCT00606697Completed51Est. May 2008
+3 more trials
Takeda
TakedaTOKYO, Japan
1 program
1
Ramelteon and gabapentinPhase 21 trial
Active Trials
NCT00755508Completed378Est. Sep 2006
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
stimulus control therapy, sleep restriction therapy, multi-component treatmentN/A1 trial
Active Trials
NCT01154023CompletedEst. Aug 2004

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstellasZolpidem MR
AstellasZolpidem MR
EisaiLemborexant
SanofiVolinanserin
Merck & Co.esmirtazapine
Sanofieplivanserin
Sanofivolinanserin
SanofiVolinanserin
Sanofivolinanserin
Astellaszolpidem MR
Boehringer IngelheimBrotizolam
AstellasFK199B
Astellaszolpidem MR
Sanofizolpidem-MR
Sanofizolpidem-MR

Showing 15 of 29 trials with date data

Clinical Trials (29)

Total enrollment: 11,219 patients across 29 trials

A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

Start: Oct 2009Est. completion: Apr 2011132 patients
Phase 4Completed

A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients

Start: May 2009Est. completion: Nov 201042 patients
Phase 4Completed
NCT04549168EisaiLemborexant

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Start: Nov 2020Est. completion: Mar 2023194 patients
Phase 3Completed
NCT00788515SanofiVolinanserin

Comparison of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

Start: Nov 2008Est. completion: Jan 200933 patients
Phase 3Terminated

Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

Start: Oct 2008Est. completion: Mar 2010184 patients
Phase 3Terminated
NCT00679900Sanofieplivanserin

Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

Start: Apr 2008Est. completion: Mar 2009283 patients
Phase 3Completed
NCT00495885Sanofivolinanserin

Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

Start: Jun 2007Est. completion: Oct 2008848 patients
Phase 3Completed
NCT00464061SanofiVolinanserin

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

Start: Apr 2007Est. completion: Mar 20091,847 patients
Phase 3Terminated
NCT00464243Sanofivolinanserin

Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study

Start: Apr 2007Est. completion: Jan 2008604 patients
Phase 3Completed

A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

Start: Aug 2006Est. completion: Jun 2008450 patients
Phase 3Completed

Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.

Start: Jun 2006Est. completion: Jan 2007253 patients
Phase 3Completed

A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

Start: Mar 2006Est. completion: Jul 200755 patients
Phase 3Completed

A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

Start: Feb 2006Est. completion: Nov 2007876 patients
Phase 3Completed

Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

Start: Aug 2004Est. completion: Jan 20061,025 patients
Phase 3Completed

Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

Start: Sep 2003Est. completion: Feb 2004113 patients
Phase 3Completed

The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

Start: May 1998146 patients
Phase 3Completed
NCT02183233Boehringer IngelheimEschscholtzia Californica

Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

Start: Jan 199849 patients
Phase 3Terminated
NCT05594589EisaiLemborexant

A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

Start: Nov 2022Est. completion: May 202465 patients
Phase 2Completed

A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia

Start: Dec 2007Est. completion: May 200851 patients
Phase 2Completed

Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia

Start: May 2006Est. completion: Jul 200768 patients
Phase 2Completed

Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

Start: Jan 2006Est. completion: Mar 2007122 patients
Phase 2Completed

Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

Start: Jan 2006Est. completion: Feb 2007342 patients
Phase 2Completed
NCT00755508TakedaRamelteon and gabapentin

Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

Start: Nov 2005Est. completion: Sep 2006378 patients
Phase 2Completed
NCT00495274GSKFormulation A

Bioequivalence and Food Effect Study in Healthy Volunteers

Start: Jul 2007Est. completion: Sep 200716 patients
Phase 1Completed
NCT00520663GSK14C-SB649868

Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

Start: Jun 2007Est. completion: Aug 20078 patients
Phase 1Completed
NCT04573556EisaiLemborexant

A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

Start: Oct 2020Est. completion: Mar 2022550 patients
N/ACompleted
NCT03276585Merck & Co.Night in Japan Home Sleep Monitoring Study

Night in Japan Home Sleep Monitoring Study

Start: Sep 2017Est. completion: Aug 20192,000 patients
N/AUnknown

Lendormin D® Tablet (Drug Use Result Survey)

Start: Jun 2005485 patients
N/ACompleted
NCT01154023T-Therapeuticsstimulus control therapy, sleep restriction therapy, multi-component treatment

Behavioral Intervention for Insomnia in Older Adults

Start: Sep 2000Est. completion: Aug 2004
N/ACompleted

Phase Legend

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

Key Insights

13 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space