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.

Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches.
People get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold).
Accordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).

Start Date01 May 2025

Sponsor / Collaborator

Flinders University

ChiCTR2500099379

/ SuspendedEarly Phase 1

Synergistic Effect of Remazolam and Dexzopiclone Doses on Sleep Quality and Postoperative Delirium in Elderly Insomnia Patients

Start Date01 Apr 2025

Sponsor / Collaborator-

NCT05953610

/ RecruitingPhase 2IIT

Endotypic Traits and Obstructive Sleep Apnea Surgery

This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).

Start Date07 Jan 2024

Sponsor / Collaborator

University of California, Los Angeles

[+1]

100 Clinical Results associated with Eszopiclone

100 Translational Medicine associated with Eszopiclone

100 Patents (Medical) associated with Eszopiclone

4,712

Literatures (Medical) associated with Eszopiclone

01 Jun 2025·Journal of the American Medical Directors Association

Agreement of Medicare Part D and Minimum Data Set Reported Psychotropic Medication Use in Nursing Homes

Article

Author: Huan, Tianwen ; Grabowski, David C ; Cai, Shubing ; Intrator, Orna ; Simning, Adam ; Boockvar, Kenneth

OBJECTIVES:

Little evidence exists on the accuracy of the Minimum Data Set (MDS)-based medication items. We compared quarterly rates of antipsychotic, antidepressant, and hypnotic use between the MDS and Part D Prescription Drug Event file (PDE) in 2018.

DESIGN:

Cross-sectional comparison.

SETTING AND PARTICIPANTS:

All US Medicare- or Medicaid-certified nursing homes were included. Long-stay nursing home residents enrolled in Medicare Part D who were aged ≥65 years with psychiatric disorders or dementia identified in the MDS data (N = 580,340) were included. Two subcohorts included the following: residents with psychiatric disorders and no Alzheimer's disease and related dementias (ADRD), and residents with ADRD.

METHODS:

Psychotropic medication use was assessed using the share of study participants who received the medication in the quarter identified by the MDS. We used Cohen kappa to assess agreement in the share of residents using psychotropic medications during the quarter and used PDE data as a reference to calculate validity parameters.

RESULTS:

The MDS-reported and PDE-reported antipsychotic (MDS vs PDE: 34.0% vs 34.3%) or antidepressant (MDS vs PDE: 73.4% vs 71.3%) users have high concordance as measured by the kappa value (antipsychotic: 0.9; antidepressant: 0.83). Sensitivity, specificity, positive predictive value, and negative predictive value of MDS data compared with PDE were 96.7%, 92.8%, 96.3%, and 93.6% for antipsychotic, and 84.5%, 96.7%, 91.1%, and 94.0% for antidepressant. Only 3.7% of study participants identified in the MDS data, vs 32.6% of PDE-based users (kappa value: 0.1), used hypnotics. By combining antianxiety medications with hypnotics, the rates of MDS hypnotic or antianxiety users increased to 35.0% (kappa value: 0.74). Sensitivity, specificity, positive predictive value, and negative predictive value were 89.5%, 85.6%, 92.8%, and 79.8%, respectively.

CONCLUSIONS AND IMPLICATIONS:

Agreement between the MDS and PDE in antipsychotic and antidepressant use was high, suggesting that the MDS is a valid tool to measure antipsychotic and antidepressant use. Additional work is needed to understand the disagreements between MDS and PDE in hypnotic use.

01 Jun 2025·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Psychotropic polypharmacy impairs walking independence in post-stroke patients

Article

Author: Hamada, Takenori ; Yoshimura, Yoshihiro ; Nagano, Fumihiko ; Yoneda, Kouki ; Kuzuhara, Aomi ; Shiraishi, Ai ; Kido, Yoshifumi ; Matsumoto, Ayaka ; Bise, Takahiro ; Shimazu, Sayuri

PURPOSE:

Psychotropic drugs are associated with adverse outcomes in older adults. However, evidence on the effect of psychotropic use on walking ability in post-stroke patients is lacking. This study examined the association between psychotropic medication use and walking independence in post-stroke patients.

METHODS:

This retrospective cohort study included stroke patients admitted for convalescent rehabilitation at a Japanese hospital between 2020 and 2022. Psychotropic medications (benzodiazepines, hypnotics, antipsychotics, and antidepressants) prescribed at admission were recorded. The primary outcome was walking independence at discharge, defined as a Functional Independence Measure (FIM) walk score ≥ 6. Logistic regression analyses examined the association between the number of psychotropic drugs and walking independence, adjusting for potential confounders.

RESULTS:

Of the 709 patients enrolled, 559 (mean age 75.5 years, 52.8% male) were included in the analysis. At admission, 25.4% of patients used psychotropic drugs. In the adjusted analysis, the number of psychotropic medications was independently associated with lower walking independence at discharge (OR 0.620, 95% CI 0.428-0.897, P = 0.011). Hypnotic use specifically showed a negative impact on walking independence (OR 0.331, 95% CI 0.154-0.708, P = 0.004). However, psychotropic drug use was not significantly associated with improvement in FIM-motor scores.

CONCLUSION:

Psychotropic polypharmacy at admission, particularly with hypnotics, was associated with reduced likelihood of achieving walking independence after stroke rehabilitation. Judicious use of psychotropic medications may be warranted when ambulation is a critical goal for older post-stroke patients.

01 Jun 2025·CLINICA CHIMICA ACTA

Advances in Z-drug detection

Review

Author: Kul, Aykut ; Sagirli, Olcay ; Al, Selen

The use of Z-drugs (zolpidem, zaleplon, zopiclone, and eszopiclone) has increased in recent years, leading to a growing need for analytical methods to accurately and reliably detect these compounds in biological samples. This review comprehensively presents the latest developments in the analysis of Z-drugs in biological samples, examining methods such as LC-MS/MS, GC-MS/MS, and HPLC. These methods have been thoroughly evaluated in biological matrices (such as blood, plasma, serum, urine, and hair), with particular focus on characteristics like sample preparation technique, calibration range, LLOQ, analysis time, mobile phase, and column. Recent studies have shown that these methods are effective in routine toxicological analysis and forensic detection of drug abuse. This review aims to provide a valuable resource for researchers and practitioners involved in the detection and analysis of Z-drugs, contributing to a better understanding and management of both therapeutic and illicit use of these compounds.

News (Medical) associated with Eszopiclone

04 Apr 2023

·www.biospace.com

Idorsia Files Petition with the Drug Enforcement Administration (DEA) Urging Them to De-Schedule Dual Orexin Receptor Antagonist Class of Insomnia Medications

RADNOR, Pa., April 4, 2023 /PRNewswire/ -- Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. The CP to de-schedule the DORA class outlines scientific and medical evidence demonstrating that the DORA class has a negligible abuse pro potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and therefore, should not be a scheduled class under the Controlled Substances Act.1 Chronic insomnia is a sleep disorder when a person has trouble falling or staying asleep. Insomnia impacts approximately 25 million American adults.2 Among the most commonly prescribed medicines that are approved to treat insomnia are benzodiazepines and Z-drugs (including zopiclone, eszopiclone, zaleplon and zolpidem).3 These drugs are only recommended for short-term use with frequent re-evaluation and due to the risk of dependance and misuse and abuse, are scheduled as Schedule IV under the Controlled Substances Act.4 The Schedule IV classification of the DORA class puts them in the same classification as benzodiazepines and Z-drugs; however, the DORA class works differently, blocking signals in the brain that stimulate wakefulness addressing chronic insomnia without creating dependence and with a negligible potential of abuse. 1 "Given the rising cases of substance abuse disorder with certain prescription medications in the United States, I'm pleased to see data from the DORA class, which shows the negligible abuse potential of DORAs when treating insomnia," said Vaughn McCall, MD, Professor and Case Distinguished Chair of the Department of Psychiatry and Health Behavior at Augusta University. "I am hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which may be abused or misused, to treat insomnia." The CP requests that the DEA Administrator initiate a rulemaking proceeding to remove the DORA class medications from scheduling under the Controlled Substances Act (CSA) based on the following three points: Eight years of post-marketing surveillance data suggests that the DORA class has an insignificant risk of abuse pro potential for abuse, lack of non-medical use in the community; and similar lack of physical or psychological dependence1. Based on major federal surveillance systems including FDA's Adverse Events Reporting System (FAERS) the rates of abuse and dependence-related reports, serious adverse events (AEs), and AEs requiring hospitalization associated with the DORA class are extremely low in incidence and substantially lower than rates for Schedule IV benzodiazepines and related drugs, including those sometimes referred to as "Z-drugs" (namely zopiclone, eszopiclone, zaleplon and zolpidem)1. A re-analysis of the Eight Factors of the Controlled Substances Act (a required step in the scheduling process) supports removal of the DORA class from scheduling under the CSA1. "Idorsia is asking the DEA to de-schedule the DORA class as part of our continued commitment to treating insomnia." said Jean-Paul Clozel, MD, Chief Executive Officer of Idorsia. "As there is significantly more data and evidence on the DORA class today than when these drugs were first approved in 2014, we believe that the DEA should reconsider its decision to schedule these drugs, considering they have negligible abuse profiles and potential for abuse. Access to the DORA class of medicines for insomnia should not be limited by the constraints put in place to manage and restrict the use of scheduled drugs or controlled substances." DORAs block the activity of orexin, they "turn down" overactive wakefulness pathways, in contrast to insomnia treatments which act via general CNS sedation. DORAs specifically target the orexin system by competitively binding and antagonizing both orexin receptors, thereby reversibly blocking the activity of orexin. Blocking orexin receptors reduces the downstream activity of the wake-promoting neurotransmitters that are overactive in insomnia. As a result, orexin receptor antagonism targets the fundamental mechanism of insomnia and does not activate dopamine neurons, thus representing much lower risks of abuse, dependence, and overdose than conventional Schedule IV drugs used to treat insomnia. A Citizen Petition can be filed to ask that a governing agency, like the DEA or US Food and Drug Administration, take or refrain from taking a particular action. Any person may Citizen Petition, and any person may comment on a petition that has been Idorsia cannot predict when or if the DEA will respond to or otherwise take any action concerning the Citizen Petition To view the petition, click here. Notes to the editor About Insomnia According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®), insomnia is defined as a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep. Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.4 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.7,8,9 References EXHIBIT B (statement of grounds) - Petition to Reschedule QUVIVIQ (daridorexant) REVISED DRAFT 3.25.23 Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153 Bertisch, S. M., Herzig, S. J., Winkelman, J. W., & Buettner, C. (2014). National use of prescription medications for insomnia: NHANES 1999-2010. Sleep, 37(2), 343–349. Sateia, M. J., Buysse, D., Krystal, A. D., Neubauer, D. N., & Heald, J. L. (2017). 0395 clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: An American Academy of Sleep Medicine Clinical Practice guideline. Sleep, 40(suppl_1). U.S. Department of Health and Human Services. (2023, March 8). Drug overdose death rates. National Institutes of Health. Retrieved March 15, 2023, from Drug Overdose Death Rates | National Institute on Drug Abuse (NIDA) (nih.gov) Ustinov Y, Lichstein KL, Wal GS, Taylor DJ, Riedel BW, Bush AJ. Association between report of insomnia and daytime functioning. Sleep Med. 2010 Jan;11(1):65-8. doi: 10.1016/j.sleep.2009.07.009. Epub 2009 Sep 23. 4. Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and Impaired Quality of Life in the United States. J Clin Psychiatry. 2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020. 5. Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591. 6. de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. PMID: 27017287. About Idorsia US Idorsia US, an affiliate of Idorsia, is reaching out for more – we have more ideas, we see more opportunities, and we want to help more patients. To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. With commercial operations based outside of Philadelphia, PA, one of densest communities of life sciences talent in the world, we are helping to realize the company's ambition of bringing innovative medicines from bench to bedside. Our goal is to build a commercial footprint that will deliver Idorsia's deep pipeline of products from its R&D engine to the US market – with the potential to change the lives of many patients. About Idorsia Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1'000 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact US Media Christopher Clark Senior Director, US Head of Communications Idorsia Pharmaceuticals US, 100 Matsonford Road, Radnor, PA 19087 +1 (215) 421 4887 christopher.clark@idorsia.com Global Investors & Media Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com media.relations@idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Company Codes: Swiss:IDIA

25 Aug 2022

·www.biospace.com

Cognesy Therapeutics Announces Senior Leadership Team to Advance Neuroplasticity Drug Discovery Platform for Neuropsychiatric Disorders

LEXINGTON, Mass.--(BUSINESS WIRE)-- Cognesy Therapeutics, a recently established company developing a platform for the discovery of neuroplasticity-inducing drugs to treat a wide range of neuropsychiatric disorders, announced appointments of its senior leadership team, the company said today. This press release features multimedia. View the full release here: Thomas C. Wessel, MD, PhD, CEO, Cognesy Therapeutics (Photo: Business Wire) The company seeks to address the worldwide medical need for novel therapeutics to treat central nervous system diseases, such as depression, anxiety, schizophrenia and dementia, as well as acquired brain disorders, such as stroke and traumatic brain injury. Collectively, these conditions affect one in eight people worldwide, and many of these patients are not adequately treated with current drugs. Cognesy’s initial investor is Gordian Ventures, an incubation fund investing in and building global life science companies. A growing body of evidence points to neuroplasticity as a shared neurobiological response underlying the clinical efficacy of different compounds, including ketamine and esketamine as well as various psychedelic agents such as psilocybin, for treating depression, post-traumatic stress disorder, and other conditions. Although these compounds have significant activity and act rapidly, their consciousness-altering, hallucinatory and other side effects present significant challenges to broader clinical use. “Our neuroplasticity-first approach has immense potential to rapidly generate compounds with promise across a broad range of psychiatric and cognitive disorders, stroke and traumatic brain disorders, substance abuse conditions and pain,” commented Tom Wessel, CEO at Cognesy Therapeutics. “Cognesy has established an outstanding team with deep experience in CNS drug discovery and development.” CSO Pete Distefano added: “Our team is building a cutting-edge neuroplasticity drug discovery platform that integrates advanced medicinal chemistry, proprietary screens for neuroplasticity, and in vivo models to assess efficacy and safety of novel compounds. We believe this approach will lead to new insights and important new agents to trigger neuroplasticity in different clinical settings.” The senior leadership team at Cognesy Therapeutics includes: Thomas C. Wessel, MD, PhD, Chief Executive Officer, is a board-certified neurologist with more than 25 years of drug development experience, including as medical lead for three CNS products approved in the United States: Razadyne® (galantamine), Lunesta® (eszopiclone) and Ampyra® (dalfampridine). Previously, Dr. Wessel served in research leadership roles at Relmada Therapeutics, Asceneuron, Flex Pharma, Acorda Therapeutics, Sepracor and Janssen Pharmaceuticals. Peter S. DiStefano, PhD, Co-founder and Chief Scientific Officer, who has more than 35 years’ drug discovery and development experience in the pharmaceutical and biotech industries. Dr. DiStefano joined Cognesy from Zebra Biologics, where he was Chief Scientific Officer. Prior to that he served as Senior Vice President of Research and Development at Second Genome, as Chief Scientific Officer, and Senior Vice President of Research and Development at Elixir Pharmaceuticals, Earlier in his career, Dr. DiStefano served in research leadership and research positions in neurology and neurobiology at Millennium Pharmaceuticals, Regeneron and Abbott Laboratories. Danny Talati, PharmD, MBA, Senior Vice President, Corporate Strategy, has spent more than 20 years in the pharmaceutical industry in a variety of roles, including sales, medical and business development. Prior to joining Cognesy, Dr. Talati was Head of Business Development at atai Life Sciences. Previously, he held roles at a number of companies, including ten years at Eli Lilly, primarily in the Neuroscience Medical division. Neuroplasticity is the process by which the brain changes through nerve cell growth, reorganization and communication to alter its function. The process is fundamental to growth, from infancy to adulthood, to learning and memory, and to recovery from brain injury. Neuroplasticity involves changes at the molecular level (e.g., expression of brain growth factors), cellular level (e.g., increases in synapses between neurons), and system levels (e.g., increased synaptic connectivity among brain regions). Cognesy’s platform is focused on the discovery of first-in-class neuroplasticity-inducing drugs with potential to treat multiple neuropsychiatric disorders. The company’s goal is to design compounds with improved therapeutic profiles – enhanced activity without side effect liabilities of existing drugs. The company’s platform integrates advanced medicinal chemistry with screens for neuroplastic activity, including neurite outgrowth and synaptogenesis, as well as assays to determine a compound’s mechanism of action and the pathway in which it acts. These assays are coupled with in vivo disease models as well as predictive models for human hallucinogenic potential. About Gordian Ventures Gordian is a global life science venture fund focused on the incubation of companies with high technical barriers to entry. Gordian’s team is comprised of successful entrepreneurs who focus on being a co-founder to each of the ventures it incubates. Gordian has offices in Lexington, Massachusetts and Shanghai, China. Learn more at . About Cognesy Therapeutics Cognesy Therapeutics is building a best-in-class platform technology to discovery of novel drugs that induce neuroplasticity for the treatment of neuropsychiatric diseases. Learn more at: .

First in Class

16 Aug 2022

·www.sciencedaily.com

Sleep medication use drops dramatically among Americans, study finds

The use of medication to treat sleep disturbances has fallen dramatically in the United States in recent years after several decades of climbing steeply, according to a new study. Americans aren't turning to pharmaceutical options as often in the never-ending battle for a good night's sleep. The use of medication to treat sleep disturbances has fallen dramatically in the United States in recent years after several decades of climbing steeply, according to a study by a team of researchers led by a University of Florida Health scientist. The study published July 12 in the Journal of Clinical Sleep Medicine documented a 31% decline in the use of common sleep medications between 2013 and 2018, a trend thought to be linked to a greater awareness of the potential pitfalls posed by these prescriptions. (It remains to be seen how the COVID-19 pandemic might have impacted this trend.) The drop-off is particularly noteworthy for Americans over age 80, who are most susceptible to falls leading to injury when using sleep medications. The study showed an 86% decrease in this group. "I was surprised and encouraged by the results because there's been a great deal of effort to minimize the long-term use of these pharmaceutical agents," said public health researcher Christopher Kaufmann, Ph.D., M.H.S., an assistant professor in the UF College of Medicine's department of health outcomes and biomedical informatics and a member of the UF Institute on Aging. "We've seen deprescribing initiatives," he added. "A number of medical organizations, advocacy groups and policymakers have also strongly discouraged the use of these drugs to treat insomnia due to potential adverse outcomes associated with their use. There are highly effective behavioral treatments available that are growing in popularity." The study's observed trend stands in marked contrast to the rapid rise of sleep medication use and prescribing in previous decades. An earlier study by some of the same researchers found that prescriptions for benzodiazepines, or BZDs, a class of drugs to treat anxiety and insomnia that includes diazepam (Valium) and alprazolam (Xanax), and non-BZDs, a similar class of medications including zolpidem (Ambien), climbed 69% and 140%, respectively, between 1993 and 2010. Kaufmann believes there are multiple reasons for the rise, including direct-to-consumer marketing, particularly with the emergence of Ambien in the early 1990s. He also said a greater awareness of the importance of sleep to general health played a critical role. The study analyzed data from the National Health and Nutrition Examination Survey, conducted every two years. Participants were asked to bring drugs they had used in the previous month or a pharmacy printout to their visits with researchers, who also inquired about the reason medication was being used. Researchers focused on medications specifically used for insomnia and other transient sleep difficulties. While the use of sleep medications dropped across all drug classes, the study found the strongest decrease in FDA-approved medications, which fell 55%. (Other sleep drugs are prescribed on an off-label basis.) The study noted BZDs and other hypnotics have been associated with the risk of motor vehicle accidents, memory impairment and, in older groups, falls and hip fractures. Indeed, in 2019 the U.S. Food and Drug Administration required the placement of a "black box warning" on prescriptions of non-BZD hypnotics such as eszopiclone (Lunesta), zolpidem (Ambien) and zaleplon (Sonata). "Past research has shown that risk of these poor outcomes increases the longer patients use these medications," said Kaufmann. Behavioral treatments for insomnia are increasingly encouraged by physicians. The gold standard, Kaufmann said, is cognitive behavioral therapy for insomnia, a program involving multiple visits to a sleep specialist to change behaviors or poor habits that cause sleep loss. But access to such care can be limited because of a dearth of providers, Kaufmann said. "Digital therapeutics" have grown in popularity, he noted. This is software accessed on a smartphone or computer that offers behavioral techniques to treat insomnia without a visit to a sleep specialist. These apps can include a virtual coach teaching lessons on building better sleeping habits and allow users to track their improvement over the course of a multiweek program. Kaufmann said these behavioral treatments have been shown to be at least as effective or even more effective than sleep drugs. Atul Malhotra, M.D., the study's senior author and a pulmonologist, intensivist and research chief of pulmonary, critical care and sleep medicine at the University of California, San Diego, said a move away from sleep drugs is a good thing. But he said he didn't want to portray these drugs as inappropriate for everyone. If behavioral treatments fail, medication might be the best option to lessen the health risks associated with chronic insomnia, which include heart disease, high blood pressure and depression. "I think these medications can be quite useful for some patients," Malhotra said. "There is a stigma attached to being on Valium or Ambien long-term. People think it's a problem. And I'd certainly rather not be on those medications than on them. But we need to remember there also is a risk with having untreated insomnia. There are ill effects of poor sleep that can't be ignored." Co-authors of the study also include researchers at Johns Hopkins University; the University of Maryland; and the University of California, Los Angeles.

100 Deals associated with Eszopiclone

External Link

KEGG	Wiki	ATC	Drug Bank
D02624	Eszopiclone	N05CF04	DB00402

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Waylis Therapeutics LLC	15 Dec 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Phase 3	United States	Sumitomo Pharma America, Inc.	01 May 2009
Parkinson Disease	Phase 3	United States	Sumitomo Pharma America, Inc.	01 May 2006
Rheumatoid Arthritis	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Feb 2004
Depressive Disorder, Major	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Jan 2004
Generalized anxiety disorder	Phase 2	United States	Sumitomo Pharma America, Inc.	01 Jan 2008
Sleep Apnea, Obstructive	Phase 2	United States	Sumitomo Pharma America, Inc.	01 Aug 2003
Sleep Disorders, Circadian Rhythm	Clinical	United States	Sumitomo Pharma America, Inc.	01 May 2009
Schizoaffective disorder	Clinical	United States	Sumitomo Pharma America, Inc.	01 Apr 2008
Schizophrenia	Clinical	United States	Sumitomo Pharma America, Inc.	01 Sep 2006
Glucose Metabolism Disorders	Clinical	United States	Sumitomo Pharma America, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04639193 (RESCUE-Combo, Pubmed \| Ann Am Thorac Soc)	Phase 2	Sleep Apnea, Obstructive	20	Acetazolamide+eszopiclone	jjhwwxtvjv(olnvcnvhfn) = cotxntnhuy lpqofimhvq (isascebpxv, -24.1 to -5.2)	Positive	08 Nov 2024
UK Biobank (ESC2024)	Not Applicable	Sleep Initiation and Maintenance Disorders	-	Z-meds	npyekfapga(kpynustair) = iycwwbmydv pslhaohyxd (wgsrtskoef ) View more	Positive	31 Aug 2024
ATS2024	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	Short-acting beta agonist (SABA) use	iuabfvytqy(eerfstuyzm) = fniembguyf nfsahqgwmf (ikogtcahmf )	-	19 May 2024
				Maintenance inhaler use	iuabfvytqy(eerfstuyzm) = oegrjxgtgj nfsahqgwmf (ikogtcahmf )
NCT04639193 (RESCUE-Combo, CTgov)	Phase 2	Sleep Apnea, Obstructive	20	Acetazolamide+Eszopiclone (Dual-Therapy)	bkvxlafxye(jpqlpvwpbg) = dstyklefmk hqqiaagyok (lfvycvggrj, gvqggjgule - ykfkfmdull) View more	-	02 May 2024
				Placebo+Acetazolamide+Eszopiclone (Placebo)	bkvxlafxye(jpqlpvwpbg) = jxikbdgvwa hqqiaagyok (lfvycvggrj, etmfyqxtcn - qcesehsqdi) View more
NCT02456532 (CIS2, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders	41	placebo (Placebo)	usjyztomyn(genagegdfn) = zzxkjfhnak jlrzzkosbt (tzfsjlqtdu, 1.6) View more	-	29 Mar 2024
				Zolpidem CR (Zolpidem CR)	usjyztomyn(genagegdfn) = yrjriceytd jlrzzkosbt (tzfsjlqtdu, 4.5) View more
NCT00812214 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Migraine Disorders \| Headache	113	placebo	hcwvgjnpwm(tjiogpdntz) = yonnncqffv hwtvpjzlpm (bkkdwjdlvl, 1.0) View more	-	15 Jun 2023
NCT01605253 (CTgov)	Phase 4	Stress Disorders, Post-Traumatic	81	Eszopiclone (Eszopiclone)	zwvqeikiff(rromgukoop) = szhadubrbe roytnllcrg (txerkkbewb, 17.61) View more	-	23 Dec 2022
				Placebo (Placebo)	zwvqeikiff(rromgukoop) = adpcayoexd roytnllcrg (txerkkbewb, 15.22) View more
NCT00392041 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Fibromyalgia	36	Eszopiclone (Eszopiclone)	amutbkioxj(tkrdjzltdv) = juulwznlcf zzunezojih (ciizjxhcvj, 69.72) View more	-	05 Jan 2021
				placebo (Placebo)	amutbkioxj(tkrdjzltdv) = dyorbcxqre zzunezojih (ciizjxhcvj, 83.21) View more
NCT00247624 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Depressive Disorder \| Behavioural disorders	60	Eszopiclone (ESZ) (Fluoxetine (FLX) Plus Eszopiclone (ESZ))	xgalvaaibo(xmliylspwk) = bicuxzpvwo wpuylgwlqp (ybzffhnlrb, 0.64) View more	-	13 Dec 2017
				Placebo+FLX (FLX Plus Placebo)	xgalvaaibo(xmliylspwk) = awhlsbjucb wpuylgwlqp (ybzffhnlrb, 0.72) View more
NCT00374556 (CTgov)	Not Applicable	Sleep Initiation and Maintenance Disorders \| Osteoarthritis	30	Placebo (Placebo)	vzwerakmyn(jfujrwyvcc) = xmroujleff ujgmshdstz (gecqdtczpa, 108.09) View more	-	09 Nov 2017
				Eszopiclone (Eszopiclone)	vzwerakmyn(jfujrwyvcc) = kpycptibpa ujgmshdstz (gecqdtczpa, 57.26) View more

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