Drugs / Eszopiclone
Eszopiclone
also known as
Lunesta · ESZ · (S)-ZOPICLONE · Estorra · Eszopiclon · Eszopiclona · Eszopiclone civ · GSK-1755165 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LUNESTA | — | 2012-10-10 | fda.gov ↗ |
| Approved | US (FDA) | LUNESTA | — | 2004-12-15 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01887691 | Oct 2012 → Aug 2015 | glucose intolerance, prediabetes syndrome, type 2 diabetes mellitus | Beth Israel Deaconess Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT00893269 | Oct 2008 → Oct 2010 | cannabis dependence | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT00368160 | Mar 2004 → Jul 2005 | insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT06928766 | Oct 2025 → May 2027 expected | obstructive sleep apnea syndrome | Flinders University | Recruiting | No outcome recorded |
| Phase 2 | NCT05953610 | Jan 2024 → Aug 2028 expected | obstructive sleep apnea syndrome | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 2 | NCT05951023 | Aug 2023 → Jul 2025 | obstructive sleep apnea syndrome | University of California, San Diego | Completed | No outcome recorded |
| Phase 2 | NCT04639193 | Dec 2020 → Jan 2022 | obstructive sleep apnea syndrome | University of California, San Diego | Completed | Met primary |
| Phase 2 | NCT04875364 | Aug 2020 → Feb 2026 | obstructive sleep apnea syndrome | University of California, San Diego | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00770510 | Sep 2008 → May 2010 | insomnia | Eisai Inc. | Completed | Met primary |
| Phase 314 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT07332442 | May 2026 → Jan 2030 expected | obstructive sleep apnea syndrome | Yale University | Recruiting | No outcome recorded |
| Phase 3 | NCT01100164 | Mar 2011 → Mar 2012 | insomnia | Eurofarma Laboratorios S.A. | Completed | Met primary |
| Phase 3 | NCT00857220 | May 2009 → Oct 2011 | attention deficit-hyperactivity disorder, insomnia | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT00856973 | May 2009 → Jul 2011 | attention deficit-hyperactivity disorder, insomnia | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT00770692 | Oct 2008 → May 2010 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00699608 | Jul → Oct 2008 | sleep disorder, initiating and maintaining sleep | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00435279 | Jun 2007 → Jul 2009 | insomnia, major depressive disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00324896 | May 2006 → Jun 2009 | Parkinson disease, insomnia | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase 3 | NCT00368056 | Apr 2005 → Jun 2006 | insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00366093 | Feb 2004 → Jan 2005 | insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00367965 | Feb → Nov 2004 | insomnia, rheumatoid arthritis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00368030 | Jan → Oct 2004 | insomnia, major depressive disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00352144 | Oct 2003 → Oct 2004 | insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01710631 | Feb 2001 → Aug 2002 | insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 415 trials · 3 met primary · 3 missed | ||||||
| Phase 4 | NCT03937713 | Dec 2019 → Sep 2024 | insomnia | VA Office of Research and Development | Completed | Missed primary |
| Phase 4 | NCT00628914 | May 2008 → Nov 2009 | insomnia, major depressive disorder | University of California, Los Angeles | Unknown | No outcome recorded |
| Phase 4 | NCT00724282 | Apr 2008 → Mar 2012 | insomnia | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00822679 | Oct 2007 → Aug 2009 | acute coronary syndrome, sleep disorder | University of Arizona | Completed | No outcome recorded |
| Phase 4 | NCT00889200 | May 2007 → Dec 2008 | insomnia | Butler Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00812214 | Apr 2007 → Sep 2008 | insomnia, migraine disorder | MedVadis Research Corporation | Completed | Missed primary |
| Phase 4 | NCT00511134 | Apr 2007 → Dec 2008 | insomnia, nicotine dependence | Yale University | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT00414037 | Dec 2006 → Dec 2008 | insomnia | University of California, San Diego | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00386334 | Oct 2006 → Feb 2008 | insomnia | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 4 | NCT00813735 | Sep 2006 → Mar 2009 | insomnia | Lehigh Center for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT00392041 | Aug 2006 → Mar 2009 | fibromyalgia, insomnia | Lesley A. Allen, Ph.D. | Completed | No outcome recorded |
| Phase 4 | NCT00247624 | Oct 2005 → Oct 2008 | depressive disorder, sleep disorder, initiating and maintaining sleep | Wake Forest University Health Sciences | Completed | Met primary |
| Phase 4 | NCT00460993 | Jun 2005 → Jun 2008 | — | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00120250 | Jun 2005 → Jun 2008 | post-traumatic stress disorder | Massachusetts General Hospital | Completed | Met primary |
| Phase 4 | NCT00781482 | — | — | Kettering Health Network | Withdrawn | No outcome recorded |
| Phase not applicable7 trials · 1 met primary | ||||||
| — | NCT01641900 | Jul 2012 → Dec 2015 | schizophrenia | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT00900159 | May 2009 → Jan 2010 | circadian rhythm sleep disorder, shift work type | Brigham and Women's Hospital | Completed | No outcome recorded |
| — | NCT00645944 | Apr 2008 → Apr 2011 | insomnia, schizoaffective disorder, schizophrenia | Yale University | Completed | Met primary |
| — | NCT00833547 | Sep 2006 → Sep 2012 | schizophrenia | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT00555750 | Mar 2006 → Jul 2008 | insomnia | Brigham and Women's Hospital | Completed | No outcome recorded |
| — | NCT00374192 | Feb 2006 → Jul 2007 | insomnia | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT00374556 | Jan 2006 → Dec 2013 | insomnia, osteoarthritis, knee | Johns Hopkins University | Completed | No outcome recorded |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT01102270 Comparator | Jan → Aug 2009 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT05349396 Comparator | Apr 2022 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1/2 | NCT05293600 Comparator | Jul 2023 → Oct 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT00616655 Comparator | Jan → Dec 2008 | generalized anxiety disorder | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00685269 Comparator | Aug 2003 → Jan 2004 | obstructive sleep apnea syndrome | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT00515177 Comparator | Aug 2007 → Jun 2009 | insomnia | University of Minnesota | Completed | No outcome recorded |
| Phase 3 | NCT03668041 Comparator | Feb 2021 → Mar 2026 | insomnia | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT07018557 Comparator | Jun 2025 → Jun 2026 overdue | hypertensive disorder, insomnia | University of Sao Paulo | Recruiting | No outcome recorded |
| Phase 4 | NCT06017921 Comparator | Aug 2023 → Oct 2025 | insomnia, obstructive sleep apnea syndrome | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02456532 Comparator | Aug 2015 → Feb 2022 | insomnia | Henry Ford Health System | Completed | No outcome recorded |
| Phase 4 | NCT01605253 Comparator | Mar 2012 → Dec 2015 | post-traumatic stress disorder | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00612157 Comparator | Jan → Jun 2008 | obstructive sleep apnea syndrome | Walter Reed Army Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00826111 Comparator | Aug 2007 → Jan 2011 | anxiety, depressive disorder, insomnia | Steward St. Elizabeth's Medical Center of Boston, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00507117 Comparator | Mar → Oct 2007 | obstructive sleep apnea syndrome | Walter Reed Army Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00365261 Comparator | Sep 2006 → Dec 2009 | sleep disorder, initiating and maintaining sleep | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT00365976 Comparator | Aug 2006 → Sep 2010 | insomnia | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00235508 Comparator | Jun 2005 → Apr 2006 | generalized anxiety disorder, insomnia | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| — | NCT06452953 Comparator | Sep 2020 → Oct 2023 | insomnia | Central South University | Completed | No outcome recorded |
| — | NCT02087488 Background | Mar 2014 → Dec 2015 | insomnia | Chengdu University of Traditional Chinese Medicine | Completed | No outcome recorded |
| — | NCT01633827 Comparator | Aug 2012 → Dec 2014 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| — | NCT00811746 Comparator | Dec 2008 → Sep 2010 | obstructive sleep apnea syndrome | Southern California Institute for Research and Education | Completed | No outcome recorded |
| — | NCT00594087 Comparator | Dec 2006 → May 2008 | relapsing-remitting multiple sclerosis, sleep disorder, initiating and maintaining sleep | University of Vermont | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths upsher-smith.com ↗
Osaka, Japan – February 15, 2021 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. |
| 2012-01-18 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia. |
| 2010-11-30 | Eisai Inc. | Regulatory EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR INSOMNIA TREATMENT SEP-190 eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that it has submitted a Marketing Authorization Application (MAA) to the Japanese Ministry of Health, Labour and Welfare seeking approval for SEP-190 (generic name: eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia. |
| 2010-09-15 | Eisai Inc. | Results JAPANESE CLINICAL TRIALS CONFIRM SAFETY AND EFFICACY OF INSOMNIA TREATMENT SEP-190 EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 eisai.com ↗
Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study's two primary outcome measures. |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eszopiclone | “Eszopiclone (Lunesta) is a new non-narcotic, non-benzodiazepine hypnotic agent which received FDA approval on December 15, 2004 for the treatment of acute and chronic insomnia.” NCT00507117 ↗65“Subjects will receive eszopiclone (in combination with medical oxygen) during their treatment arm studies” NCT01633827 ↗ “An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.” NCT00699608 ↗ “Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG” NCT00811746 ↗ |
| Known as | (S)-ZOPICLONE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | Estorra | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | ESZ | “We sought to assess the augmentation of brief behavioral therapy for insomnia (BBTI) with eszopiclone (ESZ) over BBTI alone for the treatment of chronic insomnia” PMID 40202618 ↗ Apr 20251“One week of open-label fluoxetine (FLX), followed by 8 more weeks of FLX combined with either eszopiclone (ESZ) 3 mg or placebo at bedtime.” PMID 20726279 ↗ Aug 2010 |
| Known as | Eszopiclon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | Eszopiclona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | Eszopiclone civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | GSK-1755165 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Known as | Lunesta | “Eszopiclone (Lunesta) is a new non-narcotic, non-benzodiazepine hypnotic agent which received FDA approval on December 15, 2004 for the treatment of acute and chronic insomnia.” NCT00507117 ↗7“The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep.” NCT00724282 ↗ “Over the course of the three study visits, each subject will receive eszopiclone (Lunesta), zolpidem (ambien) and a placebo in random order.” NCT00781482 ↗ “The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.” NCT00374556 ↗ “using eszopiclone (Lunesta), a medication that promotes stable sleep” NCT01887691 ↗ “Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)” NCT00414037 ↗ |
| Known as | Zopiclone s-form | ChEMBL registry synonym — accepted as the source's own label CHEMBL1522 ↗ |
| Action | Activate | “eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic” NCT00811746 ↗ |
| Modality | Small molecule | — CHEMBL1522 ↗ |
| Route | Oral | “Both groups will receive equal-appearing pills to be taken each night.” NCT00324896 ↗ |