Lunesta

(Eszopiclone)

ApprovedSmall molecule

Eszopiclone is used to help people fall asleep and stay asleep at night. It's a sedative medication prescribed for insomnia.[2] Lunesta is currently approved and in use across 17 indications[4].[1]

Lunesta is one of 417 small molecule programs targeting Schizophrenia. It is currently in Approved.

Indications

Total Trials

Active Trials

416

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

SchizophreniaActive, not recruiting

Generalized Anxiety DisorderApproved

Cannabis DependenceApproved

Sleep ApneaApproved

Multiple SclerosisActive, not recruiting

OsteoarthritisActive, not recruiting

Low Back PainActive, not recruiting

HypertensionActive, not recruiting

OSA - Obstructive Sleep ApneaRecruiting

InsomniaCompleted

SchizophreniaPreclinical

Active, not recruiting

Generalized Anxiety DisorderApproved

Approved

Cannabis DependenceApproved

Approved

Sleep ApneaApproved

Approved

Multiple SclerosisPreclinical

Active, not recruiting

OsteoarthritisPreclinical

Active, not recruiting

Low Back PainApproved

Active, not recruiting

HypertensionApproved

Active, not recruiting

OSA - Obstructive Sleep ApneaPhase 2

Recruiting

InsomniaApproved

Completed

Showing 10 of 17 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Lunesta

Akero Therapeutics

Approved

3 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Luvox

SSolvay Pharmaceuticals

Preclinical

1 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Hypertension

NCT07018557

Q1 2027

Phase 2Recruiting

OSA

NCT04875364

Q2 2027

Phase 2Recruiting

OSA - Obstructive Sleep Apnea

NCT06928766

Q2 2030

Phase 3Not yet recruiting

Obstructive Sleep Apnea

NCT07332442

Clinical

Trials by Indication[1]

Insomnia21 trials

Effectiveness of Combining Behavioral and Pharmacologic Therapy for Complex Insomnia in Veterans With PTSD

Completed·VVA Office of Research and Development·Phase 4·NCT03937713·53 enrolled

National Adaptive Trial for PTSD Related Insomnia

Active, not recruiting·VVA Office of Research and Development·Phase 3·NCT03668041·673 enrolled

Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Completed· Eisai logo

Eisai··NCT02452684·4,876 enrolled

Show 18 more trials

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia

Completed·SSteward St. Elizabeth's Medical Center of Boston, Inc.·Phase 4·NCT00826111·19 enrolled

6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00352144·830 enrolled

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00856973·486 enrolled

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00857220·304 enrolled

Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Completed·WWake Forest University Health Sciences·Phase 4·NCT00247624·60 enrolled

A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 4·NCT00386334·388 enrolled

A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

Completed·EEurofarma Laboratorios S.A.·Phase 3·NCT01100164·263 enrolled

Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder

Completed·—·N/A·NCT06452953·85 enrolled

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

Completed· Eisai logo

Eisai·Phase 2/3·NCT00770510·192 enrolled

Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01710631·791 enrolled

Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA

Recruiting·UUniversity of Sao Paulo General Hospital·Phase 4·NCT06017921·60 enrolled

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone

Completed·UUniversity of Medicine and Dentistry of New Jersey·Phase 3·NCT00324896·30 enrolled

The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women

Completed·MMassachusetts General Hospital·N/A·NCT00374192·67 enrolled

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

Completed· Eisai logo

Eisai··NCT02455271·438 enrolled

Treatment of Insomnia in Migraineurs

Completed·MMedVadis Research Corporation·Phase 4·NCT00812214·113 enrolled

Auricular Acupuncture for Primary Insomnia

Completed·—·N/A·NCT02087488·288 enrolled

Treatment of Insomnia and Glucose Metabolism

Completed·UUniversity of Chicago·Phase 4·NCT00724282·20 enrolled

Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study

Completed·UUniversity of Minnesota·Phase 2/3·NCT00515177·30 enrolled

Obstructive Sleep Apnea3 trials

Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00685269·20 enrolled

Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea

Completed·UUniversity of California, San Diego·Phase 2·NCT04639193·20 enrolled

Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea

Not yet recruiting·YYale University·Phase 3·NCT07332442·250 enrolled

Major Depressive Disorder3 trials

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Completed·LLehigh Center for Clinical Research·Phase 4·NCT00813735·60 enrolled

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00368030·545 enrolled

A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00435279·678 enrolled

Schizophrenia3 trials

Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

Completed·YYale University·N/A·NCT00645944·39 enrolled

Effects of Eszopiclone on Sleep and Memory in Schizophrenia

Completed·MMassachusetts General Hospital·N/A·NCT01641900·59 enrolled

Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia

Completed·MMassachusetts General Hospital·N/A·NCT00833547·25 enrolled

Post-Traumatic Stress Disorder2 trials

Eszopiclone for the Treatment of Posttraumatic Stress Disorder

Completed·RRush University Medical Center·Phase 4·NCT01605253·81 enrolled

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00120250·27 enrolled

26 more indications

Sleep Apnea2 trials

Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)

Completed·WWalter Reed Army Medical Center·Phase 4·NCT00612157·154 enrolled

The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome

Completed·—·Phase 1·NCT01102270·17 enrolled

Generalized Anxiety Disorder2 trials

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 4·NCT00235508·420 enrolled

Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00616655·456 enrolled

Low back pain1 trial

Study of the Insomnia in Patients With Low Back Pain

Completed·—·Phase 4·NCT00365976·58 enrolled

Sleep1 trial

How do Sleeping Pills Affect Pain in the Brain?

Terminated·UUniversity of California, San Diego·Phase 4·NCT00414037·40 enrolled

OSA1 trial

Do Endotypes Predict Response and Sequelae in OSA Patients

Recruiting·UUniversity of California, San Diego·Phase 2·NCT04875364·200 enrolled

Medication1 trial

The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Completed·JJohns Hopkins University·Phase 1·NCT00893269·36 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Chronic Hypnotic Use 2

Completed·HHenry Ford Health System·Phase 4·NCT02456532·41 enrolled

Smoking Cessation1 trial

Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban

Terminated·YYale University·Phase 4·NCT00511134·4 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions

Completed·—·Phase 1·NCT02322645·46 enrolled

Fed1 trial

Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions

Completed·—·Phase 1·NCT02322658·46 enrolled

Targeted Therapy1 trial

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)

Completed·UUniversity of California, San Diego·Phase 2·NCT05951023·42 enrolled

Menopause1 trial

Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00366093·410 enrolled

Osteoarthritis1 trial

Insomnia and Osteoarthritis Study

Completed·JJohns Hopkins University·N/A·NCT00374556·30 enrolled

Effectiveness1 trial

Sleep Effectiveness and Insulin and Glucose Homeostasis

Terminated·—·Phase 1·NCT01887691·20 enrolled

Multiple Sclerosis1 trial

Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)

Completed·UUniversity of Vermont·N/A·NCT00594087·30 enrolled

Rheumatoid Arthritis1 trial

Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00367965·153 enrolled

Fibromyalgia1 trial

Eszopiclone in the Treatment of Insomnia and Fibromyalgia

Completed·—·Phase 4·NCT00392041·36 enrolled

Driving1 trial

Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00368056·32 enrolled

Acute Coronary Syndrome1 trial

Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome

Completed·UUniversity of Arizona·Phase 4·NCT00822679·5 enrolled

Treatment1 trial

Eszopiclone Treatment & Cortisol Responsivity

Completed·—·Phase 4·NCT00889200·12 enrolled

Sleep Disturbance1 trial

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Completed·UUniversity of California, San Diego·Phase 4·NCT00365261·45 enrolled

Hypertension1 trial

Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)

Recruiting·UUniversity of Sao Paulo·Phase 4·NCT07018557·150 enrolled

Memory1 trial

Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT00368160·32 enrolled

Metabolism1 trial

Sleep Loss and Mechanisms of Impaired Glucose Metabolism

Completed·—·N/A·NCT00555750·20 enrolled

OSA - Obstructive Sleep Apnea1 trial

Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.

Recruiting·FFlinders University·Phase 2·NCT06928766·15 enrolled

Unspecified2 trials

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

Completed· Eisai logo

Eisai·Phase 1·NCT01055834·42 enrolled

Effects of Daytime Eszopiclone Administration in Shift Workers

Completed·—·N/A·NCT00900159·24 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 15, 2004

LUNESTA

NDA NDA021476

Sources

References

[1]
ClinicalTrials.gov — 61 trial records for Eszopiclone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lunesta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eszopiclone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eszopiclone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021476). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Akero Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Akero Therapeutics

Lunesta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q2 2030

Trials by Indication[1]

Insomnia21 trials

Obstructive Sleep Apnea3 trials

Major Depressive Disorder3 trials

Schizophrenia3 trials

Post-Traumatic Stress Disorder2 trials

Sleep Apnea2 trials

Generalized Anxiety Disorder2 trials

Low back pain1 trial

Sleep1 trial

OSA1 trial

Medication1 trial

Safety and Efficacy1 trial

Smoking Cessation1 trial

Fasting Conditions1 trial

Fed1 trial

Targeted Therapy1 trial

Menopause1 trial

Osteoarthritis1 trial

Effectiveness1 trial

Multiple Sclerosis1 trial

Rheumatoid Arthritis1 trial

Fibromyalgia1 trial

Driving1 trial

Acute Coronary Syndrome1 trial

Treatment1 trial

Sleep Disturbance1 trial

Hypertension1 trial

Memory1 trial

Metabolism1 trial

OSA - Obstructive Sleep Apnea1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News