MISSISSAUGA, ON, Jan. 29, 2026 /CNW/ - Eisai Limited, a leading research and development-based pharmaceutical company specializing in neurology and oncology, is deeply disappointed by Canada's Drug Agency (CDA-AMC)'s recommendation to not publicly reimburse DAYVIGO (lemborexant) for the treatment of chronic insomnia disorder (CID), characterized by difficulties with sleep onset and/or maintenance occurring at least three nights per week for a minimum of three months. This is the second time CDA-AMC has made this recommendation. In the most recent submission, Eisai submitted real-world clinical evidence demonstrating the benefit of DAYVIGO for patients and the healthcare system. Additionally, extensive patient and clinician input was provided supporting the benefits of DAYVIGO, representing 90 clinicians and four patient organizations. Despite the new evidence and overwhelming stakeholder support, reimbursement was not recommended by CDA. The implications are significant: lack of public coverage for innovative therapies like DAYVIGO creates inequities and forces patients and clinicians to choose ineffective or harmful alternatives.
This recommendation perpetuates a cycle of inadequate care and unmet need for millions of Canadians struggling with insomnia who have to rely on treatments not intended for long-term use. Furthermore, this recommendation perpetuates the use of treatments which contradict Canadian expert consensus recommendations that support the value of DAYVIGO in addressing a critical gap in chronic insomnia care.1 The Canadian consensus indicates that Dual Orexin Receptor Antagonists (DORAs) such as DAYVIGO improve sleep outcomes, with no marked rebound or withdrawal signs or symptoms when treatment is discontinued, suggesting an improved safety profile compared to commonly prescribed insomnia medications.1 The CDA's recommendation leaves clinicians' hands tied, forcing reliance on outdated and off-label treatments with well-documented safety risks – risks that CDA itself has acknowledged.2,3
DAYVIGO, amongst a class of medications known as DORAs, targets the brain's wake system to encourage natural sleep without dependence, rebound insomnia, or next-day impairment. This innovative mechanism allows patients to achieve deeper, longer-lasting sleep without compromising next-day functioning. The pivotal SUNRISE 1 and 2 studies provide the strongest evidence to date, backed by five years of safety data.4,5,6 These studies confirm its efficacy and safety for long-term use, with limited observed physical dependence, withdrawal symptoms, or tolerance.7
Beyond these studies, Eisai provided CDA with real-world evidence and diverse patient experiences confirming the long-term safety of DAYVIGO. Input from 90 clinicians and four patient groups underscored its value: "Lemborexant should be used as a first-line pharmacotherapy for patients with chronic insomnia," said the Chronic Insomnia Clinician Group in its submission to CDA.8 Further adding "It is the opinion of our clinician group that the only reason to choose another molecule over lemborexant is the current lack of financial reimbursement."
Approved by Health Canada in November 2020, DAYVIGO remains accessible only to those with private coverage or who can pay out of pocket. Currently publicly funded options in Canada, namely benzodiazepines and Z-drugs (such as zopiclone), are neither indicated nor recommended for long-term use to treat CID. Health Canada advises limiting use of these medications to just seven to ten consecutive days; however, long-term public reimbursement continues, potentially perpetuating dependence, cognitive decline, and preventable accidents.9 Continued reliance on older therapies prolongs potential harm, especially in the more vulnerable populations who are reliant on the publicly funded drug programs such as seniors and those on social assistance.
Canadian consensus recommendations identify cognitive behavioral therapy for insomnia (CBT-I), followed by DORAs, as the most suitable evidence-based approach for managing chronic insomnia. Eisai fully endorses CBT-I as the first-line treatment; however, access to CBT-I remains limited and inequitable across Canada, a gap acknowledged recently by CDA in its review of quetiapine for insomnia care.3 For patients who cannot access CBT-I, or for whom CBT-I alone is insufficient, DAYVIGO provides a clinically meaningful and safe alternative.
"As a physician who has treated thousands of patients grappling with sleep, mood, and anxiety disorders, I've seen firsthand the profound impact of insomnia on their lives. In Canada, we now have medication options that are revolutionizing how we approach insomnia treatment, enabling patients to move away from the prolonged use of benzodiazepines and other inappropriate sleep medications that can come with significant side effects. Unfortunately, most Canadians can't access DORA medications, despite strong evidence supporting their superior safety profile," said psychiatrist, Dr. Diane McIntosh. "Good quality sleep is key to improved cognitive function and better mental health. The CDA's stance fails to prioritize the need for innovative, effective and accessible treatment options for insomnia."
"At Eisai, patients and their families are at the heart of everything we do. This commitment, which we call human health care, drives us to listen, learn, and develop innovative solutions that meet the needs of those we serve," said Pat Forsythe, Vice President & General Manager, Eisai Limited. "We are dismayed at this decision that will prevent healthcare professionals - the ones on the frontlines advocating for safer options - from being able to provide the best care for their patients."
Eisai remains steadfast in our commitment to ensuring that individuals living with chronic insomnia have access to safe and effective treatment options. Guided by our human health care (hhc) mission, Eisai will continue working to close these gaps in care and ensure Canadians living with chronic insomnia receive the treatment they need.
About DAYVIGO
DAYVIGO, an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of lemborexant to orexin receptors may influence lemborexant's potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects. It has been approved for the treatment of insomnia in 22 countries including Japan, the United States, Canada, Australia and countries in Asia.
For more information about DAYVIGO in Canada, please speak to a Canadian medical professional. The full product monograph, which includes details about the indications, contraindications, dosage and administration, warnings and precautions, adverse reactions, drug interactions, action and clinical pharmacology, pharmaceutical information, clinical trials, non-clinical toxicology, and the patient medication information is available here.
About Eisai Canada
Eisai Canada was established in 2011, one of more than 40 subsidiaries of global, industry-leader Eisai Co., Ltd. Rooted in Eisai's focus on delivering human health care (hhc), Eisai Canada is on a mission to support all Canadians by creating solutions in areas where significant medical challenges and treatment gaps persist. Eisai Canada's commitment to innovative R&D and open collaboration across lines of business, industry, language and culture has resulted in an industry-leading pipeline in Neurology and Oncology. Powered by the strength of our collaborations, we discover and deliver medicines that matter to people living with Cancer, Epilepsy, Insomnia and Alzheimer's Disease.
About Eisai Co. Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (global and U.S), LinkedIn (for global, U.S. and EMEA) and Facebook (global).
Media Contacts:
Eisai Limited (Canada)
Alice Li
+1-647-861-2208
[email protected]
Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
[email protected]
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1 Morin, Charles M., Atul Khullar, Rebecca Robillard, Alex Desautels, Michael S. B. Mak, Thien Thanh Dang-Vu, Walter Chow, Jeff Habert, Serge Lessard, Lemore Alima, Najib T. Ayas, James MacFarlane, Tetyana Kendzerska, and Elliott K. Lee. "Delphi Consensus Recommendations for the Management of Chronic Insomnia in Canada." Sleep Medicine 124 (December 2024): 598–605. https://doi.org/10.1016/j.sleep.2024.09.038 |
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2 Health Canada. A Prescription for Action: A Pan-Canadian Strategy for Advancing the Appropriate Use of Prescription Medications. Ottawa, ON: Health Canada, 2025. https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/prescription-action-pan-canadian-strategy-advancing-appropriate-use-prescription-medications.html |
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3 Canadian Drug Agency (CDA-AMC). Quetiapine for Insomnia. Rapid Review with Expert Input, RC1578. Ottawa, ON: Canadian Drug Agency, November 17, 2025. https://www.cda-amc.ca/quetiapine-insomnia |
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4 Rosenberg, R., Murphy, P., Zammit, G., Mayleben, D., Kumar, D., Dhadda, S., Filippov, G., LoPresti, A., & Moline, M. (2019). Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA network open, 2(12), e1918254. https://doi.org/10.1001/jamanetworkopen.2019.18254 |
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5 Kärppä, M., Yardley, J., Pinner, K., Filippov, G., Zammit, G., Moline, M., Perdomo, C., Inoue, Y., Ishikawa, K., & Kubota, N. (2020). Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep, 43(9), zsaa123. https://doi.org/10.1093/sleep/zsaa123 |
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6 Health Canada. Notice of Compliance Information. Ottawa, ON: Health Canada, 2025. https://health-products.canada.ca/noc-ac/nocInfo?no=24557 |
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7 Takaesu, Yoshikazu, Masahiro Suzuki, Margaret Moline, Kate Pinner, Kanako Inabe, Yurie Nishi, and Kenichi Kuriyama. 2023. "Effect of Discontinuation of Lemborexant Following Long-Term Treatment of Insomnia Disorder: Secondary Analysis of a Randomized Clinical Trial." Clinical and Translational Science 16, no. 4 (January 6, 2023): 581–592. https://doi.org/10.1111/cts.13470 |
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8 Canada's Drug Agency (CDA-AMC). Patient and Clinician Group Input: Lemborexant (Dayvigo). Reimbursement Review Report, SR0895-000, April 29, 2025. Ottawa, ON: Canada's Drug Agency. https://www.cda-amc.ca/sites/default/files/DRR/2025/SR0895-Dayvigo_Patient_Clinician_Group_Input.pdf |
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9 Kamboj, Laveena, Barbara Ramos, Adam Haynes, Gurjeev Sohi, Huijuan Yang, Juejing Ling, Purva Barot, Brad Millson, and Shabbir Amanullah. "A Retrospective Observational Study to Understand Medication Utilization and Lines of Treatment in Patients With Insomnia Disorder." The Journal of Clinical Psychiatry 85, no. 4 (2024): 23m15015. https://doi.org/10.4088/JCP.23m15015 |
SOURCE Eisai Limited
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