Lemborexant
- Generic Name
- Lemborexant
- Brand Names
- Dayvigo
- Drug Type
- Small Molecule
- Chemical Formula
- C22H20F2N4O2
- CAS Number
- 1369764-02-2
- Unique Ingredient Identifier
- 0K5743G68X
- Background
Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits. Whereas historically popular pharmacologic treatments for insomnia (e.g. zopiclone, zolpidem, benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. suvorexant) act to counteract inappropriate wakefulness. This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.
- Indication
Lemborexant is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
- Associated Conditions
- Insomnia
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
- First Posted Date
- 2021-05-18
- Last Posted Date
- 2021-09-05
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 8
- Registration Number
- NCT04890561
- Locations
- 🇺🇸
PPD Phase 1 Clinic, Las Vegas, Nevada, United States
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
- Conditions
- Drug InteractionAnalgesicsOpioid Use Disorder
- Interventions
- First Posted Date
- 2021-03-26
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 18
- Registration Number
- NCT04818086
- Locations
- 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia
- First Posted Date
- 2021-02-08
- Last Posted Date
- 2023-03-15
- Lead Sponsor
- Kurume University
- Target Recruit Count
- 97
- Registration Number
- NCT04742699
- Locations
- 🇯🇵
Sleep & Stress Clinic, Shinagawa, Tokyo, Japan
🇯🇵Kuwamizu Hospital, Kumamoto, Japan
🇯🇵YOU ARIYOSHI Sleep Clinic, Kitakyushu, Fukuoka, Japan
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Sleep Apnea, ObstructiveRespiration DisordersPulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-11-30
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 63
- Registration Number
- NCT04647383
- Locations
- 🇺🇸
Pacific Research Network, San Diego, California, United States
🇺🇸St. Francis Medical Institute, Clearwater, Florida, United States
🇺🇸NeuroTrials Research Inc., Atlanta, Georgia, United States
A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.
- First Posted Date
- 2020-10-05
- Last Posted Date
- 2022-04-05
- Lead Sponsor
- Eisai Co., Ltd.
- Target Recruit Count
- 550
- Registration Number
- NCT04573556
- Locations
- 🇯🇵
Eisai trial site 1, Nagoya, Japan
🇯🇵Eisai trial site 3, Tokyo, Japan
🇯🇵Eisai trial site 2, Osaka, Japan
A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants
- First Posted Date
- 2020-09-21
- Last Posted Date
- 2021-07-19
- Lead Sponsor
- Eisai Co., Ltd.
- Target Recruit Count
- 26
- Registration Number
- NCT04555733
- Locations
- 🇨🇳
Xuhui Central Hospital, Shanghai, China
A Study of Lemborexant in Chinese Participants With Insomnia Disorder
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-09-16
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Eisai Co., Ltd.
- Target Recruit Count
- 194
- Registration Number
- NCT04549168
- Locations
- 🇨🇳
Beijing Tiantan Hosptial, Capital Medical University, Beijing, Beijing, China
🇨🇳The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China
🇨🇳Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Study of Lemborexant-Alcohol Interaction in Healthy Subjects
- First Posted Date
- 2018-03-30
- Last Posted Date
- 2018-10-17
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT03483636
- Locations
- 🇨🇦
Syneos Health, Toronto, Ontario, Canada
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep ApneaHealthy Subjects
- Interventions
- First Posted Date
- 2018-03-21
- Last Posted Date
- 2020-02-17
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 146
- Registration Number
- NCT03471871
- Locations
- 🇺🇸
The Center for Sleep & Wake Disorders, Chevy Chase, Maryland, United States
🇺🇸PACT, Glendale, Arizona, United States
🇺🇸Clinilabs Drug Development, New York, New York, United States
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
- Conditions
- Healthy Subjects
- Interventions
- First Posted Date
- 2018-03-01
- Last Posted Date
- 2018-09-06
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 50
- Registration Number
- NCT03451110
- Locations
- 🇺🇸
Worldwide Clinical Trials, San Antonio, Texas, United States
Drug Development Updates
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