VCBeat Health Contact Us
Home Dayvigo® (Lemborexant) Approved by China's NMPA: A Breakthrough in Insomnia Treatment for Millions Seeking Restful Sleep and Normal Daily Rhythms

Dayvigo® (Lemborexant) Approved by China's NMPA: A Breakthrough in Insomnia Treatment for Millions Seeking Restful Sleep and Normal Daily Rhythms

May 27, 2025 10:36 CST Updated 10:36
Eisai

Pharmaceutical Product R&D and Manufacturer

On May 27, 2025, Eisai China officially announced that the original research product of Eisai...Dual Orexin Receptor Antagonist——Lemborexant (Chinese brand name: Daweike)®) has officially been approved for marketing by the National Medical Products Administration (NMPA) of China, marking that the treatment of insomnia in China will officially enter the era of dual orexin receptor antagonists, bringing a new treatment option to patients suffering from insomnia.

 

 

Unlike traditional drugs, lemborexant precisely modulates the orexin system by competitively binding to two orexin receptor subtypes (OX1R and OX2R), inducing sleep by inhibiting the wake-promoting effects of orexin.1. Leberizine canShorten sleep onset time, reduce nighttime awakenings, and prolong total sleep time., and, unlike traditional GABA-A hypnotics that suppress REM sleep, it can simultaneouslyProlonging Non-Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep, which helps positively regulate the sleep structure, making it closer to physiological sleep.2,3Clinical trials have shown that after patients took Lemborexant, theirMinimal impact on memory and cognitive function，Patients experience minimal impact on their ability to work and perform other daily activities, especially driving, upon waking up.4,5,6LeberizineWill not lead to physical dependence,Most patients stop taking the medication after long-term use (12 months).No withdrawal symptoms, no rebound insomnia, and no addictive properties have been found since its market launch.7,8,9。

 

Currently, Lemborexant has been launched globallyApproved and marketed in more than 20 countries and regionsIn the United States, lemborexant is approved for the treatment of adult patients with insomnia who have difficulty falling asleep and/or maintaining sleep. In Japan, its indication is for the treatment of insomnia and is included in"Expert Consensus on the Treatment of Insomnia Disorders in Japan", becoming a treatment for difficulty in sleep onset and sleep maintenanceDual First-Line Recommended Drugs10According to reports, since its launch in Japan in July 2020, it has surpassed traditional drugs in terms of patient share and market share, becoming the preferred drug in Japan's insomnia treatment field. In China, lemborexant has been included"Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults (2023 Edition)", and is listed asClass IA Recommended Drugs, becoming a new target choice for insomnia treatment9。

 

Professor Zhang Bin from Nanfang Hospital, Southern Medical University, stated, "Patients with insomnia should pay attention to sleep issues, focus on adjusting their physical and mental states, and those with severe symptoms should seek professional help as early as possible to ensure early detection, early diagnosis, and early treatment. As the first dual orexin receptor antagonist with a novel mechanism, Lemborexant has been launched in China, and I believe it will become a new option for patients with insomnia. At the same time, it may also contribute to further exploration of the mechanisms of sleep-wake regulation."

 

Feng Yanhui, Senior Vice President of Eisai Global and President of Eisai China, stated, "Lemborexant has been approved for marketing in Hong Kong and Taiwan, China, and has been preliminarily utilized in some hospitals within the Greater Bay Area under the 'Hong Kong-Macao Medicine and Device Access Policy.' This formal approval by the National Medical Products Administration will provide insomnia patients with a new treatment approach and management tool. We look forward to redefining the standard for sleep health management, helping patients restore natural sleep, and contributing Eisai's strength to 'Healthy China 2030.'"

 

Eisai has positioned the field of neuroscience, including insomnia, as one of its key therapeutic areas. It focuses on continuously developing new products and providing high-quality medicines in treatment directions with significant unmet medical needs, striving to meet the unfulfilled needs of patients and their families, and contributing to the enhancement of their well-being.

 

 

 

  1. EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY. 2020, VOL. 16, NO. 11, 1063–1078.
  2. Rosenberg R, et al. JAMA Netw Open. 2019 Dec 2;2(12):e1918254.
  3. BMC Neuroscience 2014, 15:109.
  4. 4. Postgrad Med. 2021 Jan;133(1):71-81

5.Moline M, et al. Postgrad Med. 2021 Jan;133(1)71-81

6.Chepke C, et al. Prim Care Companion CNS Disord. 2025 Jan 16;27(1)

  1. J. Yardley, M. Kärppä, Y. Inoue et al. Sleep Medicine 80 (2021) 333-342
  2. Lemborexant US Package Insert
  3. "Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults" Chinese Journal of Neurology, 2024, 57(6):560-584.
  4. 《Treatment strategy for insomnia disorder: Japanese expert consensus》 Takaesu et al. 10.3389/fpsyt.2023.1168100

Number: ECN-2025-0032