Eisai’s Lemborexant (DAYVIGO®) Receives Regulatory Approval in China for the Treatment of Insomnia
Eisai Co., Ltd., a leading global pharmaceutical company headquartered in Tokyo and led by CEO Haruo Naito, announced a significant milestone in its global expansion strategy with the regulatory approval of its in-house developed insomnia treatment, DAYVIGO® (lemborexant), in China. Marketed under the brand name “达卫可®” in China, the drug has received official clearance for use in adult patients experiencing difficulties with sleep onset and/or sleep maintenance. Eisai plans to introduce DAYVIGO to the Chinese market in the second quarter of its 2025 fiscal year.
The approval represents not only a major step forward for Eisai’s global commercialization efforts but also a meaningful contribution to the treatment landscape for insomnia in China—a country where sleep disorders are highly prevalent and under-treated.
DAYVIGO: A Novel Orexin Receptor Antagonist
DAYVIGO belongs to a new class of sleep medications known as dual orexin receptor antagonists (DORAs). These agents function by selectively and competitively blocking the activity of orexin neurotransmitters, which play a crucial role in the regulation of the sleep-wake cycle. Specifically, DAYVIGO binds to the OX1R and OX2R receptors, which are involved in promoting wakefulness. By acting as a competitive antagonist, DAYVIGO inhibits the orexin signaling pathway and facilitates a more natural transition into and maintenance of sleep.
Among the two receptor subtypes, DAYVIGO shows a stronger inhibitory effect on OX2R. This feature allows the drug to suppress both rapid eye movement (REM) and non-REM sleep drive, which is believed to result in both quicker sleep onset and improved ability to maintain sleep throughout the night. Unlike traditional sedative-hypnotic drugs such as benzodiazepines or Z-drugs, which act broadly on the central nervous system, DORAs like DAYVIGO offer a targeted mechanism of action with potentially fewer side effects and less risk of dependence.
Clinical Evidence Supporting Approval in China
Eisai’s application for marketing approval in China was supported by a robust portfolio of clinical data, including results from two pivotal global Phase 3 clinical studies—SUNRISE 1 (NCT02783729) and SUNRISE 2 (NCT02952820)—as well as a Phase 3 study conducted specifically in China, known as Study 311 (NCT04549168).
- SUNRISE 1 was a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of DAYVIGO in approximately 1,000 patients. Conducted over a one-month period, it used objective polysomnography (PSG) to measure endpoints such as sleep latency and wake-after-sleep onset (WASO). The study demonstrated statistically significant improvements in both sleep onset and maintenance compared to placebo.
- SUNRISE 2 was a six-month study involving a larger and more diverse population of adult and elderly patients. This trial focused on subjective measures of sleep, such as self-reported sleep latency and sleep efficiency. It reinforced the findings from SUNRISE 1, showing sustained efficacy over time without significant safety concerns.
- Study 311, conducted in China, enrolled adult patients with insomnia to further assess the drug’s safety and efficacy in the local population. The outcomes from this study aligned with the global data and supported the case for regulatory approval by demonstrating significant improvements in sleep metrics as well as favorable tolerability.
Collectively, these trials provided compelling evidence that DAYVIGO is effective in helping patients fall asleep faster, stay asleep longer, and wake up feeling more refreshed—offering meaningful improvements in both nighttime sleep quality and daytime functioning.
Insomnia: A Growing Public Health Concern in China
Insomnia is a widespread sleep disorder marked by persistent difficulty in falling asleep, staying asleep, or achieving restorative sleep despite adequate opportunities to rest. According to standardized definitions used in clinical settings, insomnia must occur at least three times per week for a minimum duration of one month to be classified as chronic. The consequences of insomnia are far-reaching and can include cognitive impairment, emotional distress, irritability, reduced productivity, and increased risk for chronic conditions such as depression, cardiovascular disease, and diabetes.
In China, the burden of insomnia is significant. Recent epidemiological data suggests that approximately 15% of the adult population in the country suffers from insomnia, equating to more than 172 million people. Despite the scale of the problem, access to effective, evidence-based treatments remains limited for many patients, often due to lack of awareness, misdiagnosis, or concerns about the side effects and dependency risks associated with traditional sleep medications.
In this context, the approval of DAYVIGO offers a new therapeutic alternative grounded in a modern understanding of sleep neurobiology. With its targeted mechanism of action and positive safety profile, the drug is poised to make a significant impact on the quality of life for millions of Chinese patients affected by insomnia.
Expanding Global Access and Market Footprint
The approval of DAYVIGO in China adds to an expanding list of countries where the drug is now available. As of this announcement, DAYVIGO has received regulatory clearance in 22 countries and regions worldwide, including Japan, the United States, Canada, Australia, and several countries across Asia. This global expansion underscores Eisai’s strategic commitment to providing innovative, science-driven solutions to patients across diverse geographic regions.
In each market, Eisai has emphasized the dual objectives of clinical efficacy and safety, supported by a growing body of real-world evidence and post-marketing surveillance. The company has also undertaken efforts to educate healthcare providers and patients about the unique benefits of DORAs compared to older classes of hypnotic agents.
Eisai’s Commitment to Neuroscience and Patient-Centered Innovation
The approval of DAYVIGO in China reflects Eisai’s broader corporate philosophy of “human health care (hhc),” which places the patient at the center of all decision-making. As part of its global neuroscience portfolio, DAYVIGO exemplifies the company’s ambition to develop therapies that not only treat symptoms but also restore overall functioning and quality of life.
Eisai envisions that DAYVIGO can contribute meaningfully to what it terms “active daytime living”—a state in which patients are able to enjoy full cognitive and emotional engagement during the day, made possible by effective and restful sleep at night. This concept aligns with growing recognition among clinicians and public health experts that sleep health is a foundational component of overall well-being.
Looking ahead, Eisai will continue to invest in research and development, patient education, and physician training programs to ensure that DAYVIGO is integrated into clinical practice in a way that maximizes its benefits and minimizes risks. The company is also likely to explore expanded indications and new formulations to further enhance the drug’s therapeutic value.
The Chinese approval of DAYVIGO (lemborexant) marks an important milestone for Eisai and a promising advancement for insomnia treatment in one of the world’s most populous countries. Backed by strong clinical data and a novel mechanism of action, DAYVIGO stands out as a compelling option for patients who struggle with chronic sleep difficulties. As Eisai prepares to launch the drug in China later this year, it remains committed to its mission of improving lives through innovative medicines that address unmet medical needs in neurology and beyond.
