Skip to main content Accessibility help
×
Home

165 Impact of Lemborexant on Insomnia Disease Severity and Fatigue: Results from the 6-Month Placebo-Controlled Period of the Phase 3 SUNRISE-2 Study

  • Margaret Moline (a1), Mikko Kärppä (a2), Jane Yardley (a3), Dinesh Kumar (a4), Kate Pinner (a4), Carlos Perdomo (a4), Gleb Filippov (a4) and Norman Atkins (a4)...

Abstract:

Study Objective(s):

This study examined the effects of lemborexant (LEM) compared with placebo (PBO) on subject-reported insomnia disease severity, assessed by the Insomnia Severity Index (ISI), and fatigue, assessed by the Fatigue Severity Score (FSS), from the 6-month PBO-controlled period of SUNRISE-2.

Method:

SUNRISE-2 (NCT02952820; E2006-G000-303) was a 12-month randomized, double-blind, PBO-controlled (first 6-months) Phase 3 study. After an ~2-week PBO run-in, subjects were randomized to PBO, LEM 5mg (LEM5) or LEM 10mg (LEM10) for 6 months. The ISI and the FSS were administered at baseline [BL] and at the end of Months 1, 3, and 6. The ISI daytime functioning score (DFS), based on the ISI items that assess the impact of insomnia symptoms specific to daily functioning (items 4-7), was also evaluated. Mean changes from BL in ISI total score (ISI TS), ISI DFS, and FSS total score (FSS TS) were analyzed using a mixed-effect model repeated measurement analysis, adjusted for relevant factors and BL score (ISI TS, ISI DFS, or FSS TS) as a covariate.

Results:

949 subjects (PBO, n=318; LEM5, n=316; LEM10, n=315) were included in the full analysis set. Median age was 55y (range 18-88y). Mean ISI TS at BL for PBO, LEM5, and LEM10 was 19.0, 19.6 and 19.1, respectively. While mean ISI TS decreased (improved) from BL for all groups, decreases were significantly larger for both LEM5 and LEM10 vs PBO at Month 1 (least squares mean treatment difference [LSM TD]: LEM5, −1.5 [P=0.001]; LEM10, −1.9 [P<0.0001]), Month 3 (LSM TD: LEM5, −2.0; LEM10, −2.6 [both P<0.0001]), and Month 6 (LSM TD: LEM5, −2.1; LEM10, −2.4 [both P<0.0001]). Decreases from BL in mean ISI DFS were also significantly larger for LEM5 and LEM10 vs PBO at Month 1 (LSM TD: LEM5, −0.7 [P=0.014]; LEM10, −0.9 [P=0.001]), Month 3 (LSM TD: LEM5, −1.2 [P=0.0001]; LEM10, −1.4 [P<0.0001]), and Month 6 (LSM TD: LEM5, −1.3; LEM10, −1.3 [both P<0.0001]).

Mean FSS TS at BL was 35.2, 37.4, and 36.0 for PBO, LEM5, and LEM10, respectively. Mean FSS TS decreased (improved) from BL in all groups at the end of Month 1 (decreases were larger and significant for LEM10 vs PBO [LSM TD: –2.0 (P=0.026)]), and Month 3 (decreases were larger and significant for LEM5 [LSM TD: –2.2 (P=0.021)] and LEM10 [LSM TD: –3.0; (P=0.001)] vs PBO). At Month 6, mean FSS TS remained improved from BL in all treatment groups (PBO, –6.3; LEM5, –10.1; and LEM10, –8.9). These decreases were larger and significant for LEM5 (LSM TD: –2.5 [P=0.013]) and LEM10 (LSM TD: –2.6 [P=0.013]) vs PBO. LEM was well tolerated with most adverse events mild to moderate in severity.

Conclusions:

In SUNRISE-2, LEM5 and LEM10 significantly reduced subject-reported disease severity and fatigue vs PBO after 6 months of treatment. Reduced severity in insomnia symptoms with LEM5 and LEM10 also translated to improved daytime functioning.

Funding Acknowledgements:

Supported by Eisai Inc.

    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      165 Impact of Lemborexant on Insomnia Disease Severity and Fatigue: Results from the 6-Month Placebo-Controlled Period of the Phase 3 SUNRISE-2 Study
      Available formats
      ×

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      165 Impact of Lemborexant on Insomnia Disease Severity and Fatigue: Results from the 6-Month Placebo-Controlled Period of the Phase 3 SUNRISE-2 Study
      Available formats
      ×

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      165 Impact of Lemborexant on Insomnia Disease Severity and Fatigue: Results from the 6-Month Placebo-Controlled Period of the Phase 3 SUNRISE-2 Study
      Available formats
      ×

Copyright

165 Impact of Lemborexant on Insomnia Disease Severity and Fatigue: Results from the 6-Month Placebo-Controlled Period of the Phase 3 SUNRISE-2 Study

  • Margaret Moline (a1), Mikko Kärppä (a2), Jane Yardley (a3), Dinesh Kumar (a4), Kate Pinner (a4), Carlos Perdomo (a4), Gleb Filippov (a4) and Norman Atkins (a4)...

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed.