STUDY OVERVIEW - SUNRISE 1 AND SUNRISE 2
DAYVIGO™ was studied in two pivotal phase III trials
Primary endpoint (Days 29 and 30):
Mean change from baseline for:
- Latency to persistent sleep (LPS) vs. placebo
Key secondary endpoints (Days 29 and 30):
Mean change from baseline for:
- Sleep Efficiency (SEF) vs. placebo
- Wake after sleep onset (WASO) vs. placebo
Primary Endpoint (at Month 6):
Mean change from baseline for:
- Subjective sleep onset Latency (sSOL) vs. placebo
Key secondary endpoints (at Month 6):
Mean change from baseline for:
- Subjective sleep efficiency (sSEF) vs. placebo
- Subjective wake after sleep onset (sWASO) vs. placebo
All patients received instructions consistent with principles of good sleep hygiene.
PATIENT DEMOGRAPHICS
SLEEP ONSET RESULTS
DAYVIGO™ acts fast to help patients fall asleep quickly
**p<0.01 vs placebo ***p<0.001 vs placebo
Adapted from the DAYVIGO Product Monograph, Eisai Limited, November 3, 2020.
**p<0.01 vs placebo ***p<0.001 vs placebo
Adapted from the DAYVIGO Product Monograph, Eisai Limited, November 3, 2020.
Primary and secondary efficacy result for change from baseline in
polysomnographic assessment of sleep parameters
Primary and secondary efficacy result for change from baseline in
polysomnographic assessment of sleep parameters
*p<0.0001 ‡p<0.01
sSOL values were log-transformed. P values are based on the mixed-effect model
repeated measurement analysis evaluating the least squares geometric mean treatment
ratio between placebo and DAYVIGO. sSOL, subjective sleep onset latency. Yardley J, et al.
Sleep Medicine. 2021;80:333–342.
Adapted from the DAYVIGO Product Monograph, Eisai Limited,
November 3, 2020.
*p<0.0001 ‡p<0.01
sSOL values were log-transformed. P values are based on the
mixed-effect model repeated measurement analysis evaluating the
least squares geometric mean treatment ratio between placebo and
DAYVIGO. sSOL, subjective sleep onset latency. Yardley J, et al.
Sleep Medicine. 2021;80:333–342.
Adapted from the DAYVIGO Product Monograph, Eisai Limited,
November 3, 2020.
Primary and secondary efficacy result for change from baseline in
sleep diary assessment of sleep parameters through month 6
Primary and secondary efficacy result for change from baseline in
sleep diary assessment of sleep parameters through month 6
SLEEP MAINTENANCE RESULTS
DAYVIGO™ helps patients stay asleep through the night – longer
DAYVIGO sustains sleep maintenance improvement up to 6 months
†least squares mean ***p<0.001 vs placebo
Adapted from the DAYVIGO Product Monograph, Eisai Limited, November 3, 2020.
†least squares mean ***p<0.001 vs placebo
Adapted from the DAYVIGO Product Monograph, Eisai Limited,
November 3, 2020.
Primary and secondary efficacy result for change from baseline in polysomnographic assessment of sleep parameters
Primary and secondary efficacy result for change from baseline in
polysomnographic assessment of sleep parameters
*p< 0.0001 †p<0.001 ‡p< 0.01 §p<0.05
P values are based on the mixed-effect model repeated measurement analysis evaluating
the least squares geometric mean treatment ratio between placebo and DAYVIGO.
Wake After Sleep Onset (WASO): Minutes of wake from sleep onset to lights on.
Yardley J, et al. Sleep Medicine. 2021;80:333 342.
Adapted from the DAYVIGO Product Monograph, Eisai Limited, November 3, 2020.
*p< 0.0001 †p<0.001 ‡p< 0.01 §p<0.05
P values are based on the mixed-effect model repeated measurement analysis evaluating
the least squares geometric mean treatment ratio between placebo and DAYVIGO.
Wake After Sleep Onset (WASO): Minutes of wake from sleep onset to lights on.
Yardley J, et al. Sleep Medicine. 2021;80:333 342.
Adapted from the DAYVIGO Product Monograph, Eisai Limited, November 3, 2020.
Primary and secondary efficacy results for change from baseline in
sleep diary assessments of sleep parameters through month 6
Primary and secondary efficacy results for change from baseline in
sleep diary assessments of sleep parameters through month 6
Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the
patient has been carefully evaluated.
DAYVIGO™ is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance.
Click here for additional safety information and for a link to the product monograph, discussing
contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical
use.