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 "switc...

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
Associated Therapies
-

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

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

and more 20 locations

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 Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

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

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-02-22
Last Posted Date
2020-03-20
Lead Sponsor
Eisai Inc.
Target Recruit Count
24
Registration Number
NCT03440424
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-02-22
Last Posted Date
2020-03-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
16
Registration Number
NCT03443063
Locations
🇺🇸

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-11-02
Last Posted Date
2020-02-06
Lead Sponsor
Eisai Inc.
Target Recruit Count
971
Registration Number
NCT02952820
Locations
🇵🇱

Facility # 2, Warszawa, Poland

🇯🇵

Eisai Trial Site 3, Yokohama, Kanagawa, Japan

🇯🇵

Eisai Trial Site 2, Yokohama, Kanagawa, Japan

and more 8 locations

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

First Posted Date
2016-05-26
Last Posted Date
2024-11-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
1006
Registration Number
NCT02783729
Locations
🇺🇸

Saint Francis Sleep Allergy and Lung Institute, Clearwater, Florida, United States

🇨🇦

Toronto Sleep Institute, Toronto, Ontario, Canada

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 92 locations
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