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Health Canada authorizes DAYVIGO (lemborexant) for treatment of insomnia

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Health Canada authorizes DAYVIGO (lemborexant) for treatment of insomnia — MISSISSAUGA, ON, Feb. 4, 2021 – Eisai Limited, the Canadian subsidiary of Eisai Inc., today announced the Canadian authorization and availability of a new non-sedative prescription medication, DAYVIGO™ (lemborexant).  Available in both 5 mg and 10 mg dosages, DAYVIGO is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and / or sleep maintenance.1

Already approved in the United States and Japan for the treatment of insomnia, the Canadian authorization of DAYVIGO is based on two pivotal phase three studies, which established the efficacy and safety profile of the medication.1

“The Canadian authorization and availability of DAYVIGO is an important addition to Eisai’s growing product portfolio and underscores our leadership in medical research,” states Pat Forsythe, General Manager of Eisai Limited in Canada. “Our commitment to Canadian patients drives our relentless pursuit of innovative healthcare solutions.  We are pleased to introduce a new and novel treatment option to patients affected with insomnia.” 

DAYVIGO is now available in Canada for the treatment of insomnia in adults. (CNW Group/Eisai Limited)

Insomnia in Canada
Insomnia is the most prevalent sleep disorder in Canada, affecting more than 13 per cent of Canadians on a situational, recurrent or chronic basis. 2 Commonly characterized as the dissatisfaction with sleep and the difficulties to initiate and maintain sleep together with the substantial distress and impairments associated with daytime function, insomnia is more frequent with women, older people, and those with poorer physical and mental health. 2

“Insomnia disorder is a chronic condition that can have negative effects on a patient’s well-being and, if left unrecognized or untreated, may produce long-term consequences for overall health,”states Charles Morin, PhD, Professor of Psychology and Director of the Sleep Research Centre at Université Laval in Quebec City and holder of a Canada Research Chair in behavioural sleep medicine. 

Rethinking treating insomnia
Normal sleep-wake regulation occurs when the wake-promoting pathway predominates during the day, and the sleep-promoting pathway predominates at night. Patients affected by insomnia have difficulty staying asleep as a result of an imbalance and conflict between these two pathways. 2

“Helping patients with insomnia get to sleep, stay asleep longer and perform their daily routines is an important treatment goal,” declares Dr. Atul Khullar, Medical Director, Northern Alberta Sleep Clinic in Edmonton, Clinical Associate Professor, University of Alberta, and senior consultant for MedSleep, a nationwide network of community sleep clinics. “Today’s announcement is potentially groundbreaking and a needed addition to the treatment options available for adult Canadians with insomnia.”

About DAYVIGO
Discovered and developed by Eisai in-house scientists, DAYVIGO contains the active medicinal ingredient lemborexant.  DAYVIGO is a dual orexin receptor antagonist (DORA).1

DAYVIGO works by temporarily blocking the orexin signals in the brain, which can help patients fall asleep and stay asleep. This mechanism of action is opposite to that of sedative hypnotics that depress the central nervous system and induce sleep-promoting effects through increased GABA activity.3

DAYVIGO is generally well tolerated when used up to a year.1 Pivotal studies demonstrated that chronic use did not cause physical dependence. The most common side effects for DAYVIGO are headache (5 mg 6%; 10 mg 4.6%) and somnolence (5 mg 5%; 10 mg 8.4%).1

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 Limited (Canada)
Based in Mississauga, Eisai Limited (Canada) focuses on two therapeutic areas: neurology and oncology.

As a subsidiary of Eisai Inc., Eisai Limited (Canada) shares the global corporate goal of human health care (hhc), giving first thoughts to patients and their families and the help to increase the benefits health care provides.  Eisai Limited (Canada) holds a passionate commitment to patient care, which is the driving force behind its efforts to discover and develop innovative therapies to help address unmet medical needs.

DAYVIGO is a trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc.

References

1Eisai Limited. DAYVIGO (lemborexant) Product Monograph, November 3, 2020.
2Morin CM, LeBlanc M, Bélanger L, et al. Prevalence of Insomnia and its Treatment in Canada. Can J Psychiatry. 2011;56(9):540–8.
3Beuckmann CT, Suzuki M, Ueno T, et al. In Vitro and In Silico Characterization of Lemborexant (E2006), a Novel Dual Orexin Receptor Antagonist. J Pharmacol Exp Ther. 2017;362(2):287–95.

SOURCE Eisai Limited

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