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Primary Insomnia

24
Pipeline Programs
13
Companies
25
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
0
0
9
0
13
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

13 companies ranked by most advanced pipeline stage

EMS
EMSBrazil - Hortolândia
1 program
1
Zolpidem HemitartratePhase 41 trial
Active Trials
NCT01896336Completed67Est. Dec 2013
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
paroxetinePhase 4
Lundbeck
LundbeckDenmark - Copenhagen
10 programs
2
8
GaboxadolPhase 31 trial
GaboxadolPhase 31 trial
GaboxadolPhase 31 trial
GaboxadolPhase 31 trial
GaboxadolPhase 31 trial
+5 more programs
Active Trials
NCT00266344Completed520Est. Oct 2006
NCT00266357Terminated50
NCT00209937Completed675Est. Jun 2004
+7 more trials
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
6 programs
2
2
Suvorexant High DosePhase 31 trial
Suvorexant High DosePhase 31 trial
MK-6096Phase 21 trial
SuvorexantPhase 21 trial
Metabolomics of Insomnia-Related HyperarousalN/A1 trial
+1 more programs
Active Trials
NCT01957111Completed32Est. Oct 2015
NCT01960452Completed45Est. Sep 2017
NCT01021852Completed326Est. Feb 2011
+3 more trials
MSD
MSDIreland - Ballydine
6 programs
2
2
Suvorexant High DosePhase 3
Suvorexant High DosePhase 3
MK-6096Phase 2
SuvorexantPhase 2
Metabolomics of Insomnia-Related HyperarousalN/A
+1 more programs
Neurim Pharmaceuticals
Neurim PharmaceuticalsIsrael - Tel Aviv
2 programs
1
1
CircadinPhase 31 trial
Neu-P11Phase 21 trial
Active Trials
NCT01489969Completed137Est. Jan 2013
NCT00397189Completed930Est. Apr 2009
Prevail Therapeutics
1 program
1
LY2624803Phase 21 trial
Active Trials
NCT00784875Completed643Est. Feb 2010
Pfizer
PfizerNEW YORK, NY
1 program
1
PD 0200390Phase 21 trial
Active Trials
NCT00551148Completed92Est. Jan 2008
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
Metabolomics of Insomnia-Related HyperarousalN/A
Serial awakeningsN/A
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
1 program
Sleep hygiene programN/A1 trial
Active Trials
NCT02443649Completed40Est. Dec 2016
Eisai
EisaiChina - Liaoning
1 program
Eszopiclone 1 mgPHASE_2_31 trial
Active Trials
NCT00770510Completed192Est. May 2010
Vanda Pharmaceuticals
Vanda PharmaceuticalsWASHINGTON, DC
1 program
VEC-162 20 mgPHASE_31 trial
Active Trials
NCT00548340Completed322Est. Jun 2008
GSK
GSKLONDON, United Kingdom
1 program
paroxetinePHASE_41 trial
Active Trials
NCT00178048Completed66Est. Dec 2003

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
EMSZolpidem Hemitartrate
GSKparoxetine
Sharp TherapeuticsSuvorexant High Dose
Sharp TherapeuticsSuvorexant High Dose
Vanda PharmaceuticalsVEC-162 20 mg
Neurim PharmaceuticalsCircadin
LundbeckMK0928 / Duration of Treatment : 8 Weeks
Lundbeckgaboxadol
LundbeckMK0928, gaboxadol / Duration of Treatment - 6 weeks
LundbeckGaboxadol
LundbeckGaboxadol
LundbeckGaboxadol
LundbeckGaboxadol
LundbeckGaboxadol
EisaiEszopiclone 1 mg

Showing 15 of 25 trials with date data

Clinical Trials (25)

Total enrollment: 9,127 patients across 25 trials

NCT01896336EMSZolpidem Hemitartrate

Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

Start: Feb 2013Est. completion: Dec 201367 patients
Phase 4Completed
NCT00178048GSKparoxetine

Paroxetine in the Treatment of Chronic Primary Insomnia

Start: Sep 1998Est. completion: Dec 200366 patients
Phase 4Completed
NCT01097616Sharp TherapeuticsSuvorexant High Dose

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

Start: May 2010Est. completion: Dec 20111,023 patients
Phase 3Completed
NCT01097629Sharp TherapeuticsSuvorexant High Dose

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

Start: May 2010Est. completion: Nov 20111,020 patients
Phase 3Completed

VEC-162 Study in Adult Patients With Primary Insomnia

Start: Nov 2007Est. completion: Jun 2008322 patients
Phase 3Completed

Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

Start: Oct 2006Est. completion: Apr 2009930 patients
Phase 3Completed
NCT00420810LundbeckMK0928 / Duration of Treatment : 8 Weeks

Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

Start: Sep 2006138 patients
Phase 3Terminated

Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

Start: Nov 2004Est. completion: Apr 2006465 patients
Phase 3Completed
NCT00094666LundbeckMK0928, gaboxadol / Duration of Treatment - 6 weeks

Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

Start: Nov 2004Est. completion: Mar 2007465 patients
Phase 3Terminated

A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia

Start: Jul 2004Est. completion: Sep 2005200 patients
Phase 3Completed

A Study of Gaboxadol in Primary Insomnia

Start: Jun 2004Est. completion: Nov 2006320 patients
Phase 3Completed

A Study of Gaboxadol in Primary Insomnia

Start: Apr 2004Est. completion: Nov 2005505 patients
Phase 3Completed

A Study of Gaboxadol in Primary Insomnia

Start: Jun 2003Est. completion: Mar 2005600 patients
Phase 3Completed

A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Start: Jan 2003Est. completion: Jun 2004675 patients
Phase 3Completed
NCT00770510EisaiEszopiclone 1 mg

A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

Start: Sep 2008Est. completion: May 2010192 patients
Phase 2/3Completed

Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients

Start: Dec 2011Est. completion: Jan 2013137 patients
Phase 2Completed

Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

Start: Nov 2009Est. completion: Feb 2011326 patients
Phase 2Completed

Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Start: Nov 2008Est. completion: Dec 2009254 patients
Phase 2Completed

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

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

A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Start: Oct 2007Est. completion: Jan 200892 patients
Phase 2Completed
NCT00266357LundbeckMK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods

Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

Start: Nov 200550 patients
Phase 2Terminated
NCT00266344LundbeckMK0928, gaboxadol / Duration of Treatment 3 Weeks

MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

Start: Nov 2005Est. completion: Oct 2006520 patients
Phase 2Completed
NCT02443649Oregon TherapeuticsSleep hygiene program

Improving Sleep Quality in People With Insomnia

Start: Jan 2015Est. completion: Dec 201640 patients
N/ACompleted
NCT01957111Sharp TherapeuticsMetabolomics of Insomnia-Related Hyperarousal

Metabolomics of Insomnia-Related Hyperarousal

Start: Oct 2013Est. completion: Oct 201532 patients
N/ACompleted

A High Density EEG Comparison of Sleep Patterns in Insomnia

Start: Oct 2013Est. completion: Sep 201745 patients
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
13 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.