Idorsia highlights very low real-world abuse potential of DORA class for insomnia treatment at WSC 2025
MWN-AI** Summary
Idorsia Ltd presented compelling data at the World Sleep 2025 Congress, highlighting the significantly low real-world abuse potential of dual orexin receptor antagonists (DORAs) for insomnia treatment. Using the FDA Adverse Event Reporting System (FAERS) database, the analysis revealed that DORAs, including Idorsia’s daridorexant, have an abuse potential markedly lower than other insomnia therapies, including both scheduled and non-scheduled medications.
The research, conducted in collaboration with the Medical College of Georgia and Johns Hopkins University, assessed the rates of abuse-related adverse events associated with various insomnia treatments over a period from January 2014 to March 2024. The findings showed that while benzodiazepines approved for any indication had a 27.7% rate of abuse-related events, DORAs reported only 2.6%. Other treatments, such as trazodone and Z-drugs, also exhibited higher abuse rates at 22.7% and 15.3%, respectively.
Notably, DORAs' reporting odds ratios (ROR) relative to Z-drugs and trazodone indicated a very low potential for drug abuse, emphasizing their safe use in managing insomnia. This is significant because the regulatory landscape often classifies DORAs as Schedule IV drugs, yet the data suggests that this classification may exaggerate their risk for abuse.
Experts Professor William V. McCall and Professor David Neubauer echoed these findings, reinforcing that DORAs present a promising treatment option for insomnia disorder with minimal concerns regarding misuse. They advocate that the low incidence of reported adverse events supports the case for broader access to DORA therapies, potentially transforming insomnia treatment paradigms.
MWN-AI** Analysis
As Idorsia Ltd moves toward a stronger position in the insomnia treatment market, recent findings presented at World Sleep 2025 highlight the significantly low real-world abuse potential associated with dual orexin receptor antagonists (DORAs), particularly daridorexant. The analysis of data from the FDA Adverse Event Reporting System (FAERS) demonstrates that DORAs carry a substantially lower risk of abuse, with only 2.6% of reported adverse events tied to abuse-related outcomes. This figure starkly contrasts with higher rates for traditional therapies like benzodiazepines and common non-scheduled medicines such as trazodone.
The favorable safety profile of DORAs positions them as appealing alternatives in an era of heightened scrutiny regarding medication abuse. As insomnia affects about 12% of adults in the U.S., the demand for effective treatments persists despite regulatory challenges tied to abuse potential. Given the low reporting odds ratios (ROR) compared to benzodiazepines and the prominent but less regulated trazodone, DORAs may serve a crucial role in expanding treatment paradigms without compromising patient safety.
Investors should note that the positive safety profile coupled with robust clinical data could drive adoption among healthcare providers and prescribers, particularly as they seek alternatives to higher-risk options. The study also suggests that regulatory classifications may need reevaluation, as categorizing DORAs within Schedule IV could unjustifiably limit their commercialization potential.
From a market perspective, Idorsia’s advancements with DORAs represent a strategic competitive advantage, potentially enabling greater market penetration as providers look for safer insomnia management options. Given these insights, Idorsia’s position appears increasingly favorable—making it an attractive consideration for investors interested in biopharma innovation targeting widespread public health concerns.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Analysis of the FAERS database shows that the real-world abuse potential of the DORA class is very low and markedly less than those seen for other scheduled and non-scheduled insomnia therapies
Allschwil, Switzerland – September 8, 2025
Idorsia Ltd (SIX: IDIA) presented real-world data from the FDA Adverse Event Reporting System (FAERS) at the World Sleep 2025, evaluating abuse-related adverse events for dual orexin receptor antagonists (DORAs) in comparison to other insomnia therapies. View the poster .
Insomnia disorder is a chronic medical condition that is estimated to affect approximately 12% of adults in the US. Many people with insomnia disorder rely on medication for long-term management. Yet concerns around the abuse potential of certain hypnotics can limit access to effective treatments for this chronic disorder.
The study, conducted in collaboration with the Medical College of Georgia and Johns Hopkins University, examined the real-world abuse potential of approved and off-label medications used for the treatment of insomnia, employing data from the FAERS database. In this study, the percentages represent the proportion of all reported adverse events in FAERS related to cases of abuse, dependence, and withdrawal. These rates were highest for benzodiazepines approved for any indication (27.7%), followed by benzodiazepines approved for insomnia (23.0%), trazodone – not indicated or recommended for insomnia but the most prescribed insomnia medication in the US – (22.7%), doxepin (22.3%), Z-drugs (15.3%), ramelteon (8.0%), and DORAs (2.6%). DORAs were associated with a low reporting odds ratio (ROR) value relative to Z-drugs (ROR = 0.150; 95% CI [0.131, 0.171]), and to trazodone (ROR = 0.092; 95% CI [0.081, 0.105]). Similar results were obtained using the proportional reporting ratios (PRR) to measure disproportionality. These findings reinforce the favorable safety profile of DORAs such as daridorexant, supporting their role as a modern treatment option with minimal abuse potential.
Professor William V. McCall, MD, Professor Emeritus of the Department of Psychiatry and Health Behavior, Medical College of Georgia, commented: “Abuse potential has long shaped the regulation of insomnia medications, with benzodiazepines and z-drugs carrying well-known risks. This study identified a very low rate of reported cases of abuse, misuse, overdose, dependence and withdrawal for the DORA class. This rate was much lower compared with other drugs for insomnia treatment. This observation included schedule IV drugs, but also and surprisingly non-scheduled drugs.”
Professor David Neubauer, MD, Associate Professor of Psychiatry at the Johns Hopkins University School of Medicine and senior faculty of the Johns Hopkins Sleep Disorders Center, added: “The DORA class had significantly lower odds of reporting for adverse events denoting drug abuse when compared with the scheduled drug zolpidem and the non-scheduled drug trazodone, both used as a reference. This suggests that categorization of DORAs as Schedule IV drugs may overstate their abuse potential.”
About the study
Data from 1 January 2014 to 31 March 2024 were retrieved from the FAERS database. The occurrence of unsolicited reported drug abuse events defined via Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) were compared. Drugs of interest included Schedule IV drugs (benzodiazepines, Z-drugs, dual orexin receptor antagonists [DORAs]) and non-scheduled drugs (trazodone, doxepin, ramelteon). Trazodone was selected for comparison as it is one of the most widely prescribed medications for insomnia in the US, despite it not being approved for this condition. Relevant reported adverse events denoting drug abuse were identified if they contained an event with any preferred terms (PTs) from the SMQ categories: drug abuse, dependence, and withdrawal (MedDRA v26.1), with a modified SMQ applied to exclude cases with PTs associated with overdose or suicidal behaviors. Only PT's with a frequency threshold > 1% in any drug group were reported. Trazodone and zolpidem were used as reference drugs for disproportionality as they are the most widely prescribed drugs for insomnia in the US. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were used as disproportionality measures.
About World Sleep 2025
World Sleep 2025 will be the 18 th World Sleep Congress. The congress facilitates an international discussion forum and collaboration among sleep societies and sleep professionals. Sleep clinicians, technologists, trainees, educators, and scientists from around the world will meet to advance knowledge on sleep science, sleep in public health, sleep health and the sleep-wake disorders, their diagnosis and treatments.
World Sleep Society seeks to maximize learning both from formal presentations by the leading experts in their fields and from informal discussion groups emphasizing opportunities for networking and member participation.
Notes to the editor
About Dr. McCall
Dr. McCall is Professor Emeritus and also an active Professor of the Department of Psychiatry and Health Behavior at the Medical College of Georgia. He completed his medical degree and post-graduate psychiatric training at Duke University. He completed a Masters degree in Epidemiology from Wake Forest University. He is board certified in general psychiatry, geriatric psychiatry, and sleep disorders medicine. His research interests include depression, electroconvulsive therapy, quality of life, insomnia, and suicide. His research has received continuous federal support by the USA National Institute of Mental Health or similar federal institutes in Australia since 1995. He is the author of more than 500 publications, including more than 280 peer-reviewed journal articles. He is on the Editorial Boards of Sleep and the Journal of Clinical Sleep Medicine. Dr McCall serves as a consultant to Idorsia.
About Dr. Neubauer
Dr. Neubauer is Associate Professor of Psychiatry at the Johns Hopkins University School of Medicine and senior faculty of the Johns Hopkins Sleep Disorders Center. He is a Fellow of the American Academy of Sleep Medicine and Life Fellow of the American Psychiatric Association, as well as a member of the Sleep Research Society, European Sleep Research Society, and the World Sleep Society, where he serves on the International Scientific Committee. He has served on the Board of Directors and Executive Committee of the National Sleep Foundation. He is the author of the Understanding Sleeplessness: Perspective on Insomnia published by the Johns Hopkins University Press. He has written numerous journal articles and book chapters on sleep related topics. He coauthored the 2017 American Academy of Sleep Medicine “Clinical Practice Guidelines for the Pharmacologic Treatment of Chronic Insomnia in Adults” and the current Wolters Kluwer UpToDate section on Pharmacotherapy for Insomnia in Adults.” Dr. Neubauer was appointed by the American Psychiatric Association as liaison to the National Sleep Foundation Sleep Time Recommendations project. Whenever possible he champions the importance of healthy sleep as a key component in the pursuit of wellness. Dr Neubauer serves as a consultant to Idorsia.
About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).
For further information, please contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.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 “intend”, "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, business development activities 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.
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FAQ**
How does the study's finding of low abuse potential for DORAs, specifically Idorsia Ltd Registered Shares IDRSF, impact investor confidence and the company's future sales in the insomnia treatment market?
Given the favorable safety profile of DORAs compared to other insomnia therapies, what strategies is Idorsia Ltd planning to enhance the market share of Idorsia Ltd Registered Shares IDRSF among healthcare providers?
What is Idorsia Ltd's long-term vision for the DORA class, like daridorexant, in contrast to benzodiazepines and Z-drugs, as evidenced by the FAERS database analysis of Idorsia Ltd Registered Shares IDRSF?
How will Idorsia Ltd leverage the findings from the FAERS data presentation to address regulatory concerns about the categorization of DORAs, particularly concerning Idorsia Ltd Registered Shares IDRSF?
**MWN-AI FAQ is based on asking OpenAI questions about Idorsia Ltd Registered Shares (OTC: IDRSF).
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