Skip to main content

Sleep Initiation and Maintenance Disorders

27
Pipeline Programs
16
Companies
41
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
0
7
0
11
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
5 programs
3
2
Zolpidem MRPhase 41 trial
Zolpidem MRPhase 41 trial
FK199BPhase 31 trial
Zolpidem MRPhase 31 trial
zolpidem MRPhase 31 trial
Active Trials
NCT00999219Completed55Est. Jul 2007
NCT00283946Completed876Est. Nov 2007
NCT00374777Completed450Est. Jun 2008
+2 more trials
MSD
MSDIreland - Ballydine
5 programs
1
3
EsmirtazapinePhase 31 trial
SuvorexantPhase 31 trial
esmirtazapinePhase 31 trial
Org 50081Phase 11 trial
Night in Japan Home Sleep Monitoring StudyN/A1 trial
Active Trials
NCT03276585Unknown2,000Est. Aug 2019
NCT00798395Completed32Est. Sep 2008
NCT00631657Completed460Est. Nov 2009
+2 more trials
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
5 programs
1
3
EsmirtazapinePhase 3
SuvorexantPhase 3
esmirtazapinePhase 3
Org 50081Phase 1
Night in Japan Home Sleep Monitoring StudyN/A
Neurim Pharmaceuticals
Neurim PharmaceuticalsIsrael - Tel Aviv
2 programs
2
KI1001Phase 31 trial
KI1001Phase 31 trial
Active Trials
NCT02087722Completed80Est. Jan 2014
NCT01450228Completed170Est. Mar 2012
ViiV Healthcare
ViiV HealthcareNC - Durham
10 programs
4
6
GR205171Phase 2
GW679769Phase 2
GW679769Phase 2
GW679769Phase 2
GW679769Phase 2
+5 more programs
Prevail Therapeutics
2 programs
1
1
LY2422347Phase 21 trial
LY2624803 - SolutionPhase 11 trial
Active Trials
NCT01784614Completed24Est. Mar 2010
NCT00259311Completed400Est. Nov 2006
GSK
GSKLONDON, United Kingdom
6 programs
14C-SB649868PHASE_11 trial
Formulation APHASE_11 trial
GR205171PHASE_21 trial
GW679769PHASE_21 trial
GW679769PHASE_21 trial
+1 more programs
Active Trials
NCT00520663Completed8Est. Aug 2007
NCT00495274Completed16Est. Sep 2007
NCT00606697Completed51Est. May 2008
+3 more trials
Sanofi
SanofiPARIS, France
6 programs
VolinanserinPHASE_31 trial
eplivanserinPHASE_32 trials
volinanserinPHASE_31 trial
volinanserinPHASE_32 trials
zolpidem-MRPHASE_31 trial
+1 more programs
Active Trials
NCT00464061Terminated1,847Est. Mar 2009
NCT00913614Completed41Est. Dec 2009
NCT00679900Completed283Est. Mar 2009
+5 more trials
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
4 programs
Lendormin D tabletsN/A1 trial
BrotizolamPHASE_31 trial
Eschscholtzia CalifornicaPHASE_31 trial
Songha Night ®PHASE_31 trial
Active Trials
NCT02224014Completed485
NCT00347295Completed253Est. Jan 2007
NCT02183233Terminated49
+1 more trials
Eisai
EisaiChina - Liaoning
3 programs
LemborexantN/A1 trial
LemborexantPHASE_21 trial
LemborexantPHASE_31 trial
Active Trials
NCT04573556Completed550Est. Mar 2022
NCT05594589Completed65Est. May 2024
NCT04549168Completed194Est. Mar 2023
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
Night in Japan Home Sleep Monitoring StudyN/A
esmirtazapinePHASE_3
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
Program AN/A1 trial
Active Trials
NCT03687086Completed188Est. Nov 2023
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
SHIPN/A2 trials
Active Trials
NCT07560839Not Yet Recruiting260Est. Jun 2029
NCT02255721Unknown500Est. Dec 2020
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
stimulus control therapy, sleep restriction therapy, multi-component treatmentN/A1 trial
Active Trials
NCT01154023CompletedEst. Aug 2004
Takeda
TakedaTOKYO, Japan
1 program
Ramelteon and gabapentinPHASE_21 trial
Active Trials
NCT00755508Completed378Est. Sep 2006
Philips
PhilipsNetherlands - Amsterdam
1 program
EszopiclonePHASE_41 trial
Active Trials
NCT00247624Completed60Est. Dec 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
AstellasZolpidem MR
AstellasZolpidem MR
PhilipsEszopiclone
EisaiLemborexant
MSDSuvorexant
Neurim PharmaceuticalsKI1001
Neurim PharmaceuticalsKI1001
Sanofivolinanserin
MSDesmirtazapine
Sanofieplivanserin
MSDEsmirtazapine
Sanofivolinanserin
SanofiVolinanserin
Sanofivolinanserin
Astellaszolpidem MR

Showing 15 of 41 trials with date data

Clinical Trials (41)

Total enrollment: 13,719 patients across 41 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

Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Start: Oct 2005Est. completion: Dec 200860 patients
Phase 4Completed
NCT04549168EisaiLemborexant

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Start: Nov 2020Est. completion: Mar 2023194 patients
Phase 3Completed
NCT02750306MSDSuvorexant

Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)

Start: May 2016Est. completion: Sep 2018285 patients
Phase 3Completed

Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients

Start: Aug 2013Est. completion: Jan 201480 patients
Phase 3Completed

Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients

Start: Mar 2011Est. completion: Mar 2012170 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
NCT00750919MSDesmirtazapine

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
NCT00631657MSDEsmirtazapine

A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

Start: Mar 2008Est. completion: Nov 2009460 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 Subjects With Primary Insomnia

Start: Jan 2006Est. completion: Feb 2007342 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
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

Efficacy Study of LY2422347 to Treat Insomnia

Start: Nov 2005Est. completion: Nov 2006400 patients
Phase 2Completed

A Study of LY2624803 in Japanese Participants With Transient Insomnia

Start: Sep 2009Est. completion: Mar 201024 patients
Phase 1Completed
NCT00913614Sanofieplivanserin

Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia

Start: Jun 2009Est. completion: Dec 200941 patients
Phase 1Completed

A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

Start: Oct 2007Est. completion: Sep 200832 patients
Phase 1Completed
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

Accelerating Maternal and Newborn Survival: The AMANI Study

Start: Jul 2026Est. completion: Jun 2029260 patients
N/ANot Yet Recruiting
NCT04573556EisaiLemborexant

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

Start: Oct 2020Est. completion: Mar 2022550 patients
N/ACompleted

Sleep Without Insomnia or The Use of Chronic Hypnotics

Start: Dec 2018Est. completion: Nov 2023188 patients
N/ACompleted
NCT03276585MSDNight in Japan Home Sleep Monitoring Study

Night in Japan Home Sleep Monitoring Study

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

Sleep Health in Preschoolers: a Randomized Controlled Trial

Start: Nov 2013Est. completion: Dec 2020500 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

11 late-stage (Phase 3) programs, potential near-term approvals
16 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.