A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

Start Date13 Oct 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06788522

/ Not yet recruitingPhase 4IIT

The Effects of Orexin Antagonism on Fear Extinction in PTSD

PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep. Treatments for PTSD are based on fear extinction principles in which individuals are repeatedly exposed a feared cue in the absence of danger, resulting in diminishing physiological reactions, a process believed to underlie recovery from PTSD. Studies suggest that orexin, a wake-promoting neuropeptide, may enhance fear extinction. This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia. Finding a role for orexins in fear extinction will support the rationale for its further evaluation in the treatment of PTSD. Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing symptoms in Veterans with PTSD.

Start Date01 Oct 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT06679062

/ Not yet recruitingPhase 2IIT

A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.

Start Date01 Jun 2025

Sponsor / Collaborator

University of California, Los Angeles

[+1]

100 Clinical Results associated with Suvorexant

100 Translational Medicine associated with Suvorexant

100 Patents (Medical) associated with Suvorexant

553

Literatures (Medical) associated with Suvorexant

01 Sep 2025·NEUROPHARMACOLOGY

Effects of inhibiting the orexin system on nicotine reward memory and fear memory

Article

Author: Cui, Pan ; Chen, Zuxin ; Chen, Yun ; Liu, Xiaoliu ; Feng, Jialu ; Dong, Jing ; Ge, Jing ; Liu, Jianfeng ; Wu, Danping

The orexin system is associated with various brain functions, including reward processing and the stress response. Previous studies have suggested that orexin receptors (OXRs) antagonists could be beneficial in treating several mental disorders, such as drug addiction and post-traumatic stress disorder. However, the specific role of the orexin system in both appetitive (reward-related) and aversive (fear-related) memories remains unclear. In this study, we used nicotine-induced conditioned place preference (CPP) and fear conditioning models to evaluate the effects of suvorexant, a dual OXRs antagonist, and chemogenetic inhibition of orexin neurons in the lateral hypothalamus (LHA) on the retrieval, reconsolidation, and/or extinction of both nicotine reward memory and fear memory. Our findings indicated that suvorexant impaired the expression of nicotine CPP in a dose-dependent manner. These behavioral results aligned with neurochemical evidence from cFos staining, which showed activation of the LHA and orexin neurons in the LHA following the expression of nicotine CPP. Furthermore, using orexin-cre rats, we found that chemogenetic inhibition of orexin neurons in the LHA also reduced the expression of nicotine CPP. However, neither of these interventions affected the reconsolidation of nicotine reward memory. Moreover, neither suvorexant nor the chemogenetic inhibition of LHA orexin neurons affected the retrieval, reconsolidation, or extinction of fear memory, or anxiety-like behaviors, as evaluated by elevated plus maze and open field tests. In summary, our data suggest that the orexin system plays a crucial role in retrieving nicotine reward memory, and suggest that suvorexant may be a promising pharmacotherapy for treating nicotine addiction.

03 Jun 2025·Expert Opinion On Drug Safety

Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)

Article

Author: Mansur, Rodrigo B ; Rosenblat, Joshua D ; Kwan, Angela T H ; Ho, Roger ; McIntyre, Roger S ; Rhee, Taeho Greg ; Teopiz, Kayla M ; Cao, Bing ; Le, Gia Han ; Wong, Sabrina

BACKGROUND:

Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS).

METHODS:

The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC₀₂₅). IC was significantly increased when the IC₀₂₅ ≥0.

RESULTS:

Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC₀₂₅.

CONCLUSION:

We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.

01 May 2025·GENERAL HOSPITAL PSYCHIATRY

Risk of falls associated with non-GABAergic hypnotics and benzodiazepines in hospitalized patients

Article

Author: Shishida, Kazuhiro ; Takeuchi, Hiroyoshi ; Nishimura, Waka ; Murayama, Masayuki ; Shimomura, Yutaro ; Mimura, Masaru ; Yoshimura, Kimio ; Uchida, Hiroyuki

OBJECTIVE:

Non-GABAergic hypnotics introduced into clinical practice within the last two decades are pharmacologically presumed to have a lower risk of falls, but clinical investigations are scarce. We aimed to evaluate the risk of falls associated with different classes of hypnotics, namely benzodiazepines, ramelteon, suvorexant, and trazodone, in hospitalized individuals at a general hospital.

METHOD:

In this retrospective cohort study, data on the incidence of falls, hypnotic use, age, sex, body mass index (BMI), activities of daily living (ADL) score, presence of surgery, emergency admission, and ambulance use were collected for hospitalized patients aged 20 years or older who had been discharged from a tertiary general hospital in Japan between April 1, 2014, and March 31, 2019. The Cox proportional hazards model was used to examine factors associated with falls, adjusting for other demographics as covariates.

RESULTS:

Among 28,029 patients, 383 falls occurred in 322 patients. Ramelteon or suvorexant was not associated with an elevated incidence of falls (adjusted hazard ratio [aHR], 0.78; 95 % CI, 0.34 to 1.81 and 0.44; 95 % CI, 0.13-1.46, respectively), in contrast to benzodiazepines (aHR, 2.17; 95 % CI 1.67-2.83) or trazodone (aHR, 1.96; 95 % CI 1.25-3.07). Advanced age, lower BMI, wheelchair dependency, non-surgical status, absence of emergency admissions, and ambulance use were also associated with the elevated incidence of falls.

CONCLUSIONS:

In hospitalized patients at general hospitals, ramelteon and suvorexant may not increase the risk of falls, while the use of benzodiazepines and trazodone requires careful attention to minimize this risk.

News (Medical) associated with Suvorexant

30 Sep 2024

·www.globenewswire.com

Superluminal Medicines Announces Formation of Scientific Advisory Board

Multidisciplinary board members bring expertise in drug discovery, clinical development, computational life science, GPCRs and drug formulationBOSTON, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Superluminal Medicines, Inc., “The Membrane Company” using generative biology, chemistry and machine learning approaches to revolutionize the speed and accuracy of how medicines are created, today announced the formation of its Scientific Advisory Board (SAB). Comprised of renowned experts whose skillsets span drug discovery, computational life science, translational research, GCPRs, clinical trials and commercialization, the newly formed SAB has a deep understanding of Superluminal Medicines and its strategic priorities and will play a crucial role in advising the Company as it progresses its lead program into clinical development and increases the number of small molecule drug discovery programs focused on high-value G protein-coupled receptor (GPCR) targets. “The members of our new Scientific Advisory Board are world-renowned experts in their fields who have pushed the boundaries of science, established new areas of research and have brought new therapeutics to market,” said Cony D'Cruz, CEO of Superluminal Medicines. “I can think of no better set of advisors to help Superluminal Medicines take our lead program into clinical development, advance six small molecule programs and build our discovery platform to quickly and efficiently generate therapeutics for any membrane drug target.” Inaugural members of Superluminal Medicine’s Scientific Advisory Board include: Morris J. Birnbaum MD, PhD, SAB Chairman, is a physician-scientist who has led research teams in academic and pharmaceutical settings, investigating fundamental problems in metabolic regulation and their relevance to chronic disease. Dr. Birnbaum was Senior Vice President and Chief Scientific Officer, at Pfizer Inc., initially of the Cardiometabolic and later the Internal Medicine Research Unit, where he was responsible for the discovery and early clinical development of drugs designed to treat metabolic diseases. Under his leadership, Pfizer brought seven novel potential medicines into clinical development. Dr. Birnbaum has held faculty positions at Harvard Medical School, the Perelman School of Medicine at the University of Pennsylvania, and the Howard Hughes Medical Institute. Dr. Birnbaum received his AB, PhD and MD from Brown University and completed an Internal Medicine residency at Barnes Hospital at Washington University in St. Louis, followed by postdoctoral training at the University of California, San Francisco, and Sloan-Kettering Institute in New York. John Griffin, PhD, is an entrepreneur and advisor to science-driven organizations. With more than 30 years of R&D leadership experience, he is the Co-Founder and former Chief Scientific Officer of Theravance, Inc. Dr. Griffin was Chief Scientific Officer of Numerate, a startup that sought to overcome major challenges in drug discovery by applying novel machine-learning algorithms to drug design at cloud scale which was acquired by Valo Health. After the acquisition, he was Vice President at Valo Health—a technology company focused on utilizing large-scale data and AI-driven computation to discover and develop therapeutics. Dr. Griffin was also an Assistant Professor of Chemistry at Stanford University, has authored 40 publications and is co-inventor of 29 patents. He received his BS in Chemistry from Hope College, a PhD in Chemistry from the California Institute of Technology and was a National Science Foundation Postdoctoral Fellow at Harvard Medical School. Carrie Haskell-Luevano, PhD, conducts research focused on GPCRs, the neuroendocrine regulation of pain (opioid receptors), food intake and energy homeostasis (melanocortin receptors). She is the Philip S. Portoghese Endowed Chair in Chemical Neuroscience at the University of Minnesota’s Department of Medicinal Chemistry. The Haskell-Luevano laboratory uses a variety of multidisciplinary techniques and research approaches including peptide, small molecule and combinatorial chemistry synthesis; cell-based assays; chemical biology; neuromolecular pharmacology; developing knock-out mice and neuroscience. The Haskell Luevano laboratory has published over 130 peer-reviewed manuscripts, reviews, book chapters and conference proceedings. Dr. Haskell-Luevano completed her postdoctoral studies and started an independent research program at the University of Florida Department of Medicinal Chemistry, where she was promoted through the ranks of Assistant, Associate, and Full Professor. Dr. Haskell-Luevano received her BS degree in Chemistry from the California State University of Fresno and her PhD in Chemistry at the University of Arizona. Terrence Kenakin, PhD, is a leader in the use of pharmacologic tools and concepts to characterize the activity of molecules in biological systems using quantified molecular properties so that their activity can be predicted in therapeutic and other systems. Currently, Dr. Kenakin is Professor of Pharmacology at the University of North Carolina School of Medicine in Chapel Hill, where he optimizes the design of drug activity assay systems, discovery and testing of allosteric molecules for therapeutic application and quantitative modeling of drug effects. He joined Burroughs-Wellcome as an associate scientist following a postdoctoral fellowship at University College London, UK . Dr. Kenakin worked in drug discovery for 25 years at Glaxo, Inc., Glaxo Wellcome and GlaxoSmithKline’s Research and Development laboratories. He has authored numerous articles and 10 books on Pharmacology. Dr. Kenakin received his BSc in Organic Chemistry and PhD in Pharmacology from the University of Alberta in Canada. Georgia McGaughey, PhD, is a veteran scientific leader with more than 30 years of corporate experience in drug discovery and digital transformation earned at Pfizer, Merck and Vertex Pharmaceuticals. In 2024, she retired from Vertex Pharmaceuticals where she was Vice President of the global Data and Computational Sciences (DCS) group and a member of the Research Leadership Team, which is responsible for the scientific strategy and direction for the entire Vertex drug discovery portfolio. Under her leadership, the DCS group was responsible for leveraging data and advanced analytics with impact from research to FDA approval and played a central role in the approval of CASGEVY®, a gene-editing CRISPR therapy. Dr. McGaughey spent 13 years at Merck in a variety of roles in infectious diseases, CNS and other therapeutic areas, contributing directly to Belsomra®, Filorexant, MK-8189 and MK-8193, a PET-tracer used to measure target engagement for PDE10. Upon her departure from Vertex, Dr. McGaughey founded Trilligant to continue lending her expertise in digital transformation for a wide variety of businesses from sports analytics to drug discovery. Dr. McGaughey completed her PhD studies at the University of Georgia and has published over 100 peer-reviewed scientific publications and contributed to numerous patents. Sandeep Menon, MD, PhD, MPH, MS, is the Chief Development Officer at Alnylam Pharmaceuticals, where he leads a multifunctional global team and oversees end-to-end development. Before, Dr. Menon was Senior Vice President and head of Early Clinical Development at Pfizer. He oversaw Pfizer’s early clinical pipeline of assets from IND through Phase 2b across all therapeutic areas, playing a critical leadership role in increasing Pfizer’s R&D productivity resulting in a Phase II success rate of over 50%. In 2021, his team co-led the early clinical development of Paxlovid, which went from first-in-human to emergency use authorization in nine months. He also served as Chief Scientific Officer for AI and Digital Sciences, overseeing the cutting-edge Pfizer Innovation and Research Lab (PfIRE Lab), responsible for using state-of-the-art technology to develop meaningful novel quantitative digital endpoints through dynamic and remote monitoring of human behaviors. Prior to Pfizer, Dr. Menon was at Biogen where he worked on Tecfidera and Tysabri; prior to that he was a Research fellow at Harvard Clinical Research Institute. Dr. Menon received his medical degree from Karnataka University, India, his Master’s in Public Health and PhD in Biostatistics at Boston University and his MS in Translational Pharmacology from Ohio State University. He has published over 70 peer-reviewed scientific publications and book chapters and co-authored / co-edited 9 books. About Superluminal Medicines Inc. Superluminal Medicines is a generative biology and chemistry company developing a differentiated pipeline and revolutionizing the speed and accuracy of how medicine is created. The company’s platform creates candidate-ready compounds with unprecedented speed using a comprehensive combination of deep biology and chemistry expertise, machine learning, and proprietary big data infrastructure. The predict-design-test architecture accurately models protein shapes and designs highly selective compounds to target the precise structural change for therapeutic effect. Its discovery engine is powered by an industry-leading, pharmacokinetic and toxicology in silico prediction capability. The company’s proprietary pipeline validates its platform with initial programs focused on high-value GPCR targets. Based in Boston, the company is backed by a strong network of investors including RA Capital Management, Insight Partners, NVentures, Catalio Capital Management, Eli Lilly and Company, Gaingels, and Cooley LLP. For more, visit www.superluminalrx.com. Media ContactJanine McCargo6 Degreesjmccargo@6degreespr.com

AcquisitionExecutive ChangePhase 2

22 Aug 2024

·www.prnewswire.com

NATIONALLY RECOGNIZED BEHAVIORAL SCIENTIST DR. KELLY DUNN NAMED DIRECTOR OF THE KAHLERT INSTITUTE FOR ADDICTION MEDICINE AT THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

BALTIMORE, Aug. 22, 2024 /PRNewswire/ -- University of Maryland School of Medicine (UMSOM) Dean Mark T. Gladwin, MD, announced today the appointment of Kelly Dunn, PhD, MBA, one of the nation's leading researchers on opioid use disorder, as the inaugural Director of the School's Kahlert Institute for Addiction Medicine. She will also serve as a Professor in the Department of Psychiatry with a secondary appointment in the Department of Neurobiology at UMSOM. Dr. Dunn is currently a Professor of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine with a joint appointment in Health Policy and Management at the Johns Hopkins University School of Public Health. Dr. Dunn has been the Principal Investigator on projects totaling more than $21 million in awards from the National Institutes of Health. She has authored more than 130 peer-reviewed publications in the area of substance use and opioid use disorder. The Kahlert Institute for Addiction Medicine, launched in 2023 with a major gift from the Kahlert Foundation, is uniquely positioned to bring together leading addiction experts from across basic science and clinical care to transform the prevention, treatment, education, and research of addiction. "With addiction, substance use disorder, and overdose deaths reaching epidemic proportions here in Maryland and in the U.S., we are extremely pleased to attract a top academician and leader in this field to move the Institute forward with a long-term impact," said Dean Gladwin. Growing up in rural Central New York in the late 1990's, Dr. Dunn watched several close friends become dependent on opioids, after first being exposed through prescription medications, and eventually go on to develop opioid use disorder (OUD). "This prompted my life-long passion for understanding motivations for opioid use, identifying methods to prevent the onset of OUD, and helping to improve treatments for OUD," said Dr. Dunn. "I'm honored and thrilled to take the helm of the Kahlert Institute and to work together with all of the stellar faculty who are world-class leaders in addiction research to advance the science of addiction medicine." Since 2012, Dr. Dunn has been a faculty member in the Johns Hopkins University Behavioral Pharmacology Research Unit (BPRU) located within the Department of Psychiatry and Behavioral Sciences. Her current work focuses on the conduct of Phase II/III randomized controlled assessments of medications, mainly those targeted for opioid use disorder. She has also managed trials focused on treatments for cigarette smoking and alcohol use disorder and has conducted several basic science human laboratory examinations of drug effects, which is complemented by a body of work focused on epidemiological and machine-learning analyses of publicly available datasets. She has held multiple leadership roles in the substance use field, including serving as President for the American Psychological Association's Society for Psychopharmacology and Substance Use and the College on the Problems of Drug Dependence (CPDD) as well as Co-Editor of the Journal of Addiction Medicine and Editor-in-Chief of the journal Experimental and Clinical Psychopharmacology. "Dr. Dunn's current work in the field is impressive, " said Greg Kahlert, President of The Kahlert Foundation. "I am confident with her experience, passion and collaborative spirit, she will help find treatments and cures for those suffering from addiction. I could not be more excited that she is the first director of the Kahlert Institute for Addiction Medicine." Dr. Dunn is currently the principal investigator on a multisite examination of a treatment for co-morbid pain in people with opioid use disorder. She is also an investigator on a Phase II trial examining the use of the drug suvorexant to treat sleep disorders, withdrawal, and craving in people initiating treatment with buprenorphine for opioid use disorder. Other studies include a combination laboratory/clinical trial examining phenotypes of opioid withdrawal and a pilot trial examination of suvorexant for cocaine use in people being treated for OUD. Dr. Dunn recently completed a series of human laboratory trials examining genetic contributions to opioid sensitivity and opioid-cannabinoid interactions for pain treatment in healthy and clinical populations. In addition to her numerous peer-reviewed original and review publications, Dr. Dunn edited the Oxford Handbook on Opioids and Opioid Use Disorder. She received her PhD Degree from the University of Vermont in 2009 and earned an MBA Degree from Johns Hopkins University Carey School of Business in 2019. This news release was issued on behalf of Newswise™. For more information, visit SOURCE University of Maryland School of Medicine

Phase 2Executive Change

16 Nov 2023

·medcitynews.com

We’re at a Turning Point for Alzheimer’s Disease Research

Right now, roughly six million Americans are forgetting their lives as a result of Alzheimer’s— a devastating disease that progressively interferes with, and eventually destroys, cognitive function and memory— and unless we do something drastic about it, this number will more than double by 2050. That’s a tall order considering that both 2022 and 2023 were hailed as the “era of Alzheimer’s Disease treatments” and it’s likely that medical advancements for Alzheimer’s will continue strong well into 2024. As we learn more about the disease and dementia in general, the closer we come to putting an end to Alzheimer’s once and for all. What we know about Alzheimer’s dictates how we develop treatments The exact cause of Alzheimer’s is unknown. However, scientists believe that its onset and progression are connected to changes in the brain. These changes include the buildup of reactive and toxic proteins— including beta-amyloid 42— around brain cells and neurons. In turn, this causes inflammation and damage that disrupts cellular and neural activity and ultimately results in decreased memory, cognitive function, and eventually the ability to carry out the simplest of tasks, like dialing a phone number. Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease. There are two categories of drugs approved by the FDA for the treatment of Alzheimer’s: drugs that treat the cognitive and non-cognitive symptoms of the disease, and drugs that change disease progression. Treatments available to patients now are offering hope and some relief There are currently five FDA-approved drugs available for the treatment of the cognitive symptoms of Alzheimer’s Disease, like memory and thinking— donepezil, galantamine, rivastigmine, memantine, and memantine + donepezil— and two FDA-approved drugs for the treatment of non-cognitive symptoms— suvorexant for insomnia, and brexpiprazole for agitation. Treatments specifically targeted at slowing the decline of cognitive function in patients with early Alzheimer’s have provided some hope in recent years. There are just two treatments currently approved for the change of progression in Alzheimer’s Disease, though there are also promising drug candidates in development right now. Just two years ago, in 2021, the FDA approved aducanumab, a breakthrough treatment for Alzheimer’s Disease that data shows can slow the progression of the disease in patients with early or mild Alzheimer’s, ultimately increasing and extending quality of life. Lecanemab (Elsai and Biogen) received accelerated approval in January 2023 for its potential to slow cognitive decline in patients with early to moderate Alzheimer’s. Lecanemab also has shown no signs of being able to reverse the symptoms or provide long-term, sustained improvement, even after 18 months of treatment. Drug candidate donanemab (Eli Lilly and Company) is showing significant progress in stemming the progression of Alzheimer’s Disease from one stage to the next in clinical trials. Though all of these treatments come with side effects, this rapid progress in the treatment of Alzheimer’s Disease is helping patients right now while researchers continue to improve on these and other treatments. The future of Alzheimer’s Disease diagnosis and treatment There is currently no FDA-approved Alzheimer’s Disease treatment on the market that can reverse the symptoms and damage done by the disease. But that doesn’t mean it won’t ever happen. In fact, right now, researchers are working on new treatment candidates for Alzheimer’s Disease that are showing promising results. Last year, a new treatment candidate made headlines when results from phase 2a clinical trials showed not only that the drug could improve cognition and function during the one-month double-blind study, but that it was happening in patients with moderate to severe Alzheimer’s. Importantly, those improvements happened with little to no side effects. The Open Label Extension (OLE) study that followed showed disease reversal in 47 percent and disease stabilization in 28 percent of participants, including those with severe Alzheimer’s Disease, after only three months of treatment. An upcoming phase 2b clinical trial will collect and analyze clinical data in moderate to severe Alzheimer’s patients over the course of a full year to further prove the efficacy, safety, and sustainability of the treatment. The outcome of the phase 2b clinical trials, paired with prior results, could help to put this new treatment on an accelerated pathway to distribution, a move that if it occurs, would mark the availability of the first drug with the potential to reverse the effects of Alzheimer’s Disease. As exciting as this future is, there’s more work yet to be done. Patients typically have Alzheimer’s Disease long before they experience outward symptoms. Known as pre-clinical Alzheimer’s Disease, the effects of dementia can begin to occur 10 to 15 years before patients experience the types of symptoms that result in doctor’s visits and diagnosis. Diagnosis itself can also require many medical appointments over successive months, and treatment may not always begin right away. We need better diagnostics paired with earlier diagnosis and improved patient access and education. Empowering patients and their families to understand symptoms, family history, and what to do about it are critical in combatting the devastating effects of Alzheimer’s Disease. The best diagnostics in the world, paired with the best treatments, or even an eventual cure, won’t help if people don’t know when to talk to their medical provider. A future without Alzheimer’s Disease could be just over the horizon. But we have to all work together to make it happen.

Phase 2Drug ApprovalClinical Result

100 Deals associated with Suvorexant

External Link

KEGG	Wiki	ATC	Drug Bank
D10082	Suvorexant	N05CM19	DB09034

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	United States	Merck Sharp & Dohme Corp.	13 Aug 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Delirium	Phase 3	Japan	Merck Sharp & Dohme Corp.	22 Oct 2020
Alzheimer Disease	Phase 3	-	Merck Sharp & Dohme Corp.	23 May 2016
Pulmonary Disease, Chronic Obstructive	Phase 1	-	Merck Sharp & Dohme LLC	25 Mar 2011
Sleep Apnea, Obstructive	Phase 1	-	Merck Sharp & Dohme Corp.	19 Mar 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03110315 (DREAM, CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Fatigue \| Multiple Sclerosis	36	Suvorexant (Suvorexant)	vrhghbjokn(pyfjdtamwo) = jvqmqfovkw qyvinvlcdi (tmbasauxhf, ddwahtrqlm - dmkycszyrr) View more	-	03 Feb 2025
				Placebo (Placebo)	vrhghbjokn(pyfjdtamwo) = jeqtqsjitm qyvinvlcdi (tmbasauxhf, bdxppqpxwp - znzwydxmqm) View more
NCT02729714 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Parkinson Disease	21	Suvorexant (Suvorexant Period)	wfmhvvrnfz(vxinnangim) = jijdhvnpir yvxrclebku (nnbcapvedc, mxfesvdzyt - neqgktauoo)	-	20 Aug 2024
				placebo (Placebo)	wfmhvvrnfz(vxinnangim) = ngfecisijy yvxrclebku (nnbcapvedc, brlkftfkul - yxihjwrywg) View more
NCT04571944 (Pubmed \| JAMA Netw Open) Manual	Phase 3	Delirium mild cognitive impairment \| mild dementia \| history of delirium	203	Suvorexant 15 mg	cknjmizjbm(cyccipwwoz) = dnxmhncflk orooctwuiv (hbabmnibah )	Negative	01 Aug 2024
				Placebo	cknjmizjbm(cyccipwwoz) = dwikopydzy orooctwuiv (hbabmnibah )
NCT04571944 (CTgov)	Phase 3	Delirium	207	Suvorexant (Suvorexant)	xrdpypisme = jpkdgkbwun skzqjbrksp (aziicvvthh, hqybqughge - pnnxakwoej) View more	-	20 May 2024
				Placebo (Placebo)	xrdpypisme = dwwarkjdys skzqjbrksp (aziicvvthh, trddgvmbaf - cjeafvzpgf) View more
NCT03412591 (Suvsubuse, CTgov)	Phase 2/3	Alcoholism \| Sleep Initiation and Maintenance Disorders \| Adrenocortical Hyperfunction ... View more	28	Suvorexant 20 mg (Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder)	fbgjdivitv(hoathqecjn) = einheshoks idbozicpfm (vhcgfpfsyp, 61.96) View more	-	12 Feb 2024
				Suvorexant 20 mg (Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder)	fbgjdivitv(hoathqecjn) = sjocoardpw idbozicpfm (vhcgfpfsyp, 41.42) View more
NCT04706091 (CTgov)	Phase 4	Sleep Initiation and Maintenance Disorders \| Restless Legs Syndrome	46	Placebo+Suvorexant (Treatment --> Placebo)	qzjndlgyxu(uloegcowcg) = kqybzjltzr zeyzvenwnl (bjlivzqxlg, 40.80) View more	-	16 Jan 2024
				Placebo+Suvorexant (Placebo --> Treatment)	qzjndlgyxu(uloegcowcg) = ompxyestab zeyzvenwnl (bjlivzqxlg, 24.16) View more
WSC2023	Not Applicable	-	-	Suvorexant 30 mg/Kg	daimkqcdpv(rptdbddptu) = jupihulijm eooctoyxot (aulllcfqla, 3.1) View more	-	23 Oct 2023
				Vehicle	daimkqcdpv(rptdbddptu) = zplewkslql eooctoyxot (aulllcfqla, 1.2) View more
NCT02849548 (CTgov)	Phase 4	Stress Disorders, Post-Traumatic	27	suvorexant (Suvorexant)	jyjceycetq(zrodgpglih) = oczsicmjdh virteozykm (zfqxzhenvo, 7.3) View more	-	02 Jun 2023
				placebo (Placebo Pill)	jyjceycetq(zrodgpglih) = xqanzpjqff virteozykm (zfqxzhenvo, 12) View more
NCT04229095 (CTgov)	Phase 2	Alcoholism	26	Suvorexant 20 mg (Belsomra,(Suvorexant))	deosbqnlgt(busunwsvdz) = rhmqvebywc shnwmgiwub (xdyzysfuwv, 0.90) View more	-	26 Apr 2023
				Placebo oral tablet (Placebo)	deosbqnlgt(busunwsvdz) = tbgbckavzc shnwmgiwub (xdyzysfuwv, 0.62)

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Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis