Eisai Inc, the US pharmaceutical subsidiary of Eisai Co Ltd, will present new DAYVIGO (lemborexant) CIV research at the SLEEP 2020 virtual conference, August 27-30, 2020. DAYVIGO, a dual orexin receptor antagonist, was recently launched in the United States for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Highlights include an oral presentation focusing on the long-term efficacy and safety of DAYVIGO in adults ages 65 and older with insomnia disorder from the Phase 3 clinical study, SUNRISE 2, in which patients were evaluated for up to 12 months. Additional research to be presented will explore sleep onset and sleep maintenance responder profiles over 12 months of treatment with DAYVIGO, efficacy and safety of DAYVIGO in females of perimenopausal age with insomnia disorder, and impact of DAYVIGO treatment on fatigue severity. In addition, interim results from a multi-center pilot study evaluating the next-dose transition from zolpidem to DAYVIGO for the treatment of insomnia will be presented.
“We look forward to sharing new findings about safety and efficacy of DAYVIGO in specific patient populations, particularly those related to its long-term impact in individuals 65 years and older, at SLEEP 2020,” says Lynn Kramer, MD, chief clinical officer, neurology business group, Eisai, in a release. “These findings will provide key considerations for addressing insomnia in specific patient populations. Insomnia affects millions of people in the United States. This research is especially relevant now, as we know life changes due to the COVID-19 pandemic are causing increased sleep problems.”
Eisai’s research to be presented at SLEEP 2020 includes:
- Oral O-01 (0474): Long-Term Efficacy and Safety of Lemborexant in Elderly Adults with Insomnia Disorder: Results from SUNRISE-2
- Poster 473: Effectiveness and Safety of Lemborexant in Subjects Previously Treated with Placebo for 6 Months in SUNRISE-2
- Poster 477: Characteristics of Insomnia Subjects Screened for Transitioning From Zolpidem Tartrate to Lemborexant in a Multicenter Pilot Study
- Poster 478: A Multicenter Open-Label Pilot Study to Evaluate Next-Dose Transition from Zolpidem to Lemborexant for the Treatment of Insomnia
- Poster 479: Sleep Onset and Sleep Maintenance Responder Profiles Over 12 Months of Treatment with Lemborexant: Results from SUNRISE-2
- Poster 480: Efficacy and Safety of Lemborexant In Female Subjects of Perimenopausal Age with Insomnia Disorder
- Poster 481: Impact of Lemborexant on Fatigue Severity in Subjects With Clinically Significant Levels of Fatigue at Baseline
- Poster 484: How Much Improvement In Subject-Reported Sleep Onset Latency Is Needed for Patients to Report a Positive Impact of Their Insomnia Medication?
- Poster 486: Impact of Intrinsic Factors on Efficacy of Lemborexant: Subgroup Analyses of SUNRISE-2
“SLEEP 2020 is particularly exciting for Eisai as we recently launched DAYVIGO for adults with insomnia in the U.S. and Japan and are filing for approval in other countries,” said Ivan Cheung, chairman, Eisai Inc and global president, neurology business group, Eisai Co Ltd, in a release. “Eisai has created new digital tools including an online sleep tracker and other patient resources to allow us to serve insomnia patients in a more holistic manner.”