Primary Insomnia

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

EMSBrazil - Hortolândia

1 program

Zolpidem HemitartratePhase 41 trial

Active Trials

NCT01896336Completed67Est. Dec 2013

ViiV HealthcareNC - Durham

1 program

paroxetinePhase 41 trial

Active Trials

NCT00178048Completed66Est. Dec 2003

LundbeckDenmark - Copenhagen

10 programs

GaboxadolPhase 31 trial

+5 more programs

Active Trials

NCT00266344Completed520Est. Oct 2006

NCT00266357Terminated50

NCT00209924Completed505Est. Nov 2005

+7 more trials

MSDIreland - Ballydine

6 programs

Suvorexant High DosePhase 3

MK-6096Phase 2

SuvorexantPhase 2

Metabolomics of Insomnia-Related HyperarousalN/A

+1 more programs

Sharp TherapeuticsPA - Pittsburgh

6 programs

Suvorexant High DosePhase 3

MK-6096Phase 2

SuvorexantPhase 2

Metabolomics of Insomnia-Related HyperarousalN/A

+1 more programs

Neurim PharmaceuticalsIsrael - Tel Aviv

2 programs

CircadinPhase 31 trial

Neu-P11Phase 21 trial

Active Trials

NCT01489969Completed137Est. Jan 2013

NCT00397189Completed930Est. Apr 2009

Prevail TherapeuticsNY - New York

1 program

LY2624803Phase 21 trial

Active Trials

NCT00784875Completed643Est. Feb 2010

PfizerNEW YORK, NY

1 program

PD 0200390Phase 21 trial

Active Trials

NCT00551148Completed92Est. Jan 2008

Merck & Co.RAHWAY, NJ

2 programs

Metabolomics of Insomnia-Related HyperarousalN/A1 trial

Serial awakeningsN/A1 trial

Active Trials

NCT01957111Completed32Est. Oct 2015

NCT01960452Completed45Est. Sep 2017

Oregon TherapeuticsFrance - Paris

1 program

Sleep hygiene programN/A1 trial

Active Trials

NCT02443649Completed40Est. Dec 2016

EisaiChina - Liaoning

1 program

Eszopiclone 1 mgPHASE_2_31 trial

Active Trials

NCT00770510Completed192Est. May 2010

Vanda PharmaceuticalsWASHINGTON, DC

1 program

VEC-162 20 mgPHASE_31 trial

Active Trials

NCT00548340Completed322Est. Jun 2008

GSKLONDON, United Kingdom

1 program

paroxetinePHASE_4

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

EMSZolpidem Hemitartrate

ViiV Healthcareparoxetine

Vanda PharmaceuticalsVEC-162 20 mg

Neurim PharmaceuticalsCircadin

LundbeckMK0928 / Duration of Treatment : 8 Weeks

Lundbeckgaboxadol

LundbeckMK0928, gaboxadol / Duration of Treatment - 6 weeks

LundbeckGaboxadol

EisaiEszopiclone 1 mg

Neurim PharmaceuticalsNeu-P11

Prevail TherapeuticsLY2624803

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 6,504 patients across 21 trials

NCT01896336 EMSZolpidem 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

NCT00178048 ViiV Healthcareparoxetine

Paroxetine in the Treatment of Chronic Primary Insomnia

Start: Sep 1998Est. completion: Dec 200366 patients

Phase 4Completed

NCT00548340 Vanda PharmaceuticalsVEC-162 20 mg

VEC-162 Study in Adult Patients With Primary Insomnia

Start: Nov 2007Est. completion: Jun 2008322 patients

Phase 3Completed

NCT00397189 Neurim PharmaceuticalsCircadin

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

Start: Oct 2006Est. completion: Apr 2009930 patients

Phase 3Completed

NCT00420810 LundbeckMK0928 / Duration of Treatment : 8 Weeks

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

Start: Sep 2006138 patients

Phase 3Terminated

NCT00094627 Lundbeckgaboxadol

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

Start: Nov 2004Est. completion: Apr 2006465 patients

Phase 3Completed

NCT00094666 LundbeckMK0928, gaboxadol / Duration of Treatment - 6 weeks

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

Start: Nov 2004Est. completion: Mar 2007465 patients

Phase 3Terminated

NCT00209950 LundbeckGaboxadol

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

Start: Jul 2004Est. completion: Sep 2005200 patients

Phase 3Completed

NCT00209846 LundbeckGaboxadol

A Study of Gaboxadol in Primary Insomnia

Start: Jun 2004Est. completion: Nov 2006320 patients

Phase 3Completed

NCT00209924 LundbeckGaboxadol

A Study of Gaboxadol in Primary Insomnia

Start: Apr 2004Est. completion: Nov 2005505 patients

Phase 3Completed

NCT00209963 LundbeckGaboxadol

A Study of Gaboxadol in Primary Insomnia

Start: Jun 2003Est. completion: Mar 2005600 patients

Phase 3Completed

NCT00209937 LundbeckGaboxadol

A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia

Start: Jan 2003Est. completion: Jun 2004675 patients

Phase 3Completed

NCT00770510 EisaiEszopiclone 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

NCT01489969 Neurim PharmaceuticalsNeu-P11

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

NCT00784875 Prevail TherapeuticsLY2624803

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

Start: Oct 2008Est. completion: Feb 2010643 patients

Phase 2Completed

NCT00551148 PfizerPD 0200390

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

Start: Oct 2007Est. completion: Jan 200892 patients

Phase 2Completed

NCT00266357 LundbeckMK0928, 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

NCT00266344 LundbeckMK0928, 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

NCT02443649 Oregon TherapeuticsSleep hygiene program

Improving Sleep Quality in People With Insomnia

Start: Jan 2015Est. completion: Dec 201640 patients

N/ACompleted

NCT01960452 Merck & Co.Serial awakenings

A High Density EEG Comparison of Sleep Patterns in Insomnia

Start: Oct 2013Est. completion: Sep 201745 patients

N/ACompleted

NCT01957111 Merck & Co.Metabolomics of Insomnia-Related Hyperarousal

Metabolomics of Insomnia-Related Hyperarousal

Start: Oct 2013Est. completion: Oct 201532 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & 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.