Help Patients Fall Asleep Faster and Stay Asleep Longer1
DAYVIGO was assessed vs placebo across 2 pivotal trials including nearly 2000 adult patients. DAYVIGO wasdemonstrated superior to placebo across these 2 pivotal trials.
The recommended dosage of DAYVIGO is 5mg taken no more than once per night. The dose may by increased
to the maximum recommended dose of 10mg based on clinical response and tolerability.
SLEEP ONSET
Sleep Maintenance
WAKE AFTER
SLEEP ONSET
Sleep Maintenance
SLEEP EFFICIENCY
SLEEP ONSET
Time to sleep onset measures the amount of time it takes patients to fall asleep
SUNRISE 1 (sleep labs)
DAYVIGO reduced time to sleep onset, as
assessed by the primary endpoint (mean* change
from baseline in LPS vs placebo at Month 1).1
SLEEP LABS (1 Month)1,2
SUNRISE 2 (patient diaries)
DAYVIGO reduced time to sleep onset, as
assessed by the primary endpoint (mean* change
from baseline in sSOL vs placebo at Month 6).1
PATIENT DIARIES
(6 Months)1,3
LPS=latency to persistent sleep; sSOL=subjective sleep onset latency.
*For the sleep onset endpoints (LPS, sSOL), the mean refers to least squares geometric mean, which was used due to the approximately log normal distribution of the outcomes.1
‡ Treatment effect refers to the ratio of [Day 29/30 LPS / Baseline LPS] or [Month 6 sSOL / Baseline sSOL] for DAYVIGO vs placebo, such that a smaller ratio corresponds to a greater improvement.
Sleep Onset With DAYVIGO vs Active Comparator and
Placebo Through Month 1
Key primary endpoint:
Mean* change from baseline in LPS at Month 1 for DAYVIGO 5 mg and
10 mg compared to placebo.
1
Prespecified exploratory endpoints:
Mean* change from baseline in LPS at Month 1 for
DAYVIGO 5 mg and 10 mg compared to zolpidem ER. Mean* change from baseline in LPS at
Day 1/2 for DAYVIGO 5 mg and
10 mg
compared to placebo and zolpidem ER.1,2
Sleep Onset (LPS)
Over Time1,2
Limitations:
Prespecified exploratory endpoints were not adjusted for multiplicity and were
not adequately powered to show statistical significance. These data are not intended to imply
the superiority of DAYVIGO vs zolpidem ER.4
Subjective Sleep Onset With
DAYVIGO vs Placebo
Through Month 6
Key primary endpoint:
Mean* change from baseline in sSOL at Month 6 for DAYVIGO 5 mg
and 10 mg compared to
placebo.1
Prespecified exploratory endpoints:
Mean* change from baseline in sSOL at First 7 Days,
Month 1, and Month 3 for DAYVIGO
5 mg and 10 mg compared to zolpidem ER.1,3
Sleep Onset (sSOL) Over Time1,3
Limitations: Prespecified exploratory endpoints were
not adjusted for multiplicity and were
not adequately powered to show statistical
significance.5
ER=extended release; LPS=latency to persistent sleep; sSOL=subjective sleep onset latency.
*For the sleep onset endpoints
(LPS, sSOL), the mean refers to least squares geometric mean,
which was used due
to the approximately log normal distribution of the outcomes.1
SLEEP MAINTENANCE
Wake After Sleep Onset (WASO)
WASO measures the amount of time spent awake after initially falling asleep
SUNRISE 1 (sleep labs)
DAYVIGO reduced WASO, as assessed by the
secondary endpoint (mean* change from baseline
in WASO vs placebo at Month 1).1
SLEEP LABS (1 Month)1,2
SUNRISE 2 (patient diaries)
DAYVIGO reduced sWASO, as assessed by the
secondary endpoint (mean* change from baseline
in sWASO vs placebo at Month 6).1
PATIENT DIARIES
(6 Months)1,3
sWASO=subjective wake after sleep onset; WASO=wake after sleep onset.
*For sleep maintenance endpoints (WASO, sWASO), the mean refers to least squares mean.1
WASO With DAYVIGO vs Active Comparator and Placebo
Through Month 11,2
Key secondary endpoint:
Mean change from baseline in WASO at Month 1 for DAYVIGO 5 mg and
10 mg compared to placebo.1
Prespecified exploratory endpoints:
Mean change from baseline in WASO at Month 1 for
DAYVIGO vs zolpidem ER. Mean change from baseline in WASO at Day 1/2 for DAYVIGO vs
placebo and zolpidem ER.1,2
WASO Over Time1,2,4
Limitations:
Prespecified exploratory endpoints were not adjusted for multiplicity and were
not adequately powered to show statistical significance. These data are not intended to imply
the superiority of DAYVIGO vs zolpidem ER.4
Key secondary endpoint: Mean change from baseline in sWASO at Month 6 for DAYVIGO 5 mg and 10 mg compared to placebo.1
Prespecified exploratory endpoints: Mean change from baseline in sWASO at First 7 Days, Month 1, and Month 3 for DAYVIGO vs placebo.1,3
sWASO Over Time1,3
Limitations: Prespecified exploratory endpoints were not adjusted for multiplicity and were not adequately powered to show statistical significance.5
ER=extended release; sWASO=subjective wake after sleep onset; WASO=wake after sleep onset.
* For sleep maintenance endpoints (WASO, sWASO), the mean refers to least squares mean.1
Sleep Efficiency (SEF)
SEF is measured by the amount of time spent asleep divided by the total time spent in bed.
SUNRISE 1 (sleep labs)
DAYVIGO increased SEF, as assessed by the
secondary endpoint (mean* change from baseline
in SEF vs placebo at Month 1).1
SLEEP LABS (1 Month)1,2
SUNRISE 2 (patient diaries)
DAYVIGO increased sSEF, as assessed by the
secondary endpoint (mean* change from baseline
in sSEF vs placebo at Month 6).1
PATIENT DIARIES
(6 Months)1,3
SEF=sleep efficiency; sSEF=subjective sleep efficiency.
*For sleep maintenance endpoints (SEF, sSEF), the mean refers to least squares mean.1
SEF With DAYVIGO vs Active Comparator and Placebo
Through Month 11,2
Key secondary endpoint: Mean change from baseline in SEF at Month 1 for DAYVIGO 5 mg and
10 mg compared to placebo.1,2
Prespecified exploratory endpoints: Mean change from baseline in SEF at Month 1 for
DAYVIGO vs zolpidem ER. Mean change from baseline in SEF at Day 1/2 for DAYVIGO vs
placebo and zolpidem ER.1,2
SEF Over Time1,2
Limitations:
Prespecified exploratory endpoints were not adjusted for multiplicity and were
not adequately powered to show statistical significance. These data were not intended to imply
the superiority of DAYVIGO vs zolpidem ER.4
sSEF With DAYVIGO vs Placebo Through Month 61,3
Key secondary endpoint: Mean change from baseline in sSEF at Month 6 for DAYVIGO 5 mg
and 10 mg compared to placebo.1
Prespecified exploratory endpoints: Mean change from baseline in sSEF to First 7 Days,
Month 1, and Month 3 for DAYVIGO vs placebo.3
sSEF Over Time1,3
Limitations: Prespecified exploratory endpoints were not adjusted for multiplicity and were not
adequately powered to show statistical significance.5
ER=extended release; SEF=sleep efficiency; sSEF=subjective sleep efficiency.
*For sleep maintenance endpoints (SEF, sSEF), the mean refers to least squares mean.1
6-Month Parallel-Group Extension Period6
Prespecified Exploratory Endpoints
The initial 6-month placebo-controlled treatment period was followed by a
6-month
parallel-group extension period.6
At the start of the extension period, patients taking DAYVIGO in the 6-month
placebo-controlled study continued on their previous dose of DAYVIGO during the
6-month
parallel-group extension period. Patients on placebo during the 6-month
placebo-controlled
study were re-randomized to either DAYVIGO 5 mg or 10 mg.6
sSEF Over Time6 (DAYVIGO Patients Continued on DAYVIGO)
sSEF Over Time6 (Placebo Patients Re-Randomized to DAYVIGO)
The placebo group during the 6-month placebo-controlled study re-randomized to DAYVIGO 5
mg (n=128) and 10 mg (n=122) at the start of the extension period showed baseline sSEF
values at Month 6 (0 months of DAYVIGO exposure) of 70.5% and 71.1%, respectively. The
mean change from baseline, sSEF measures at Month 9 (3 months of DAYVIGO exposure) are
4.7% (5 mg), 5.1% (10 mg) and at Month 12 (6 months of DAYVIGO exposure) are 3.9% (5 mg)
and 4.5% (10 mg).
Limitations: Prespecified exploratory endpoints were not adjusted for multiplicity and were
not adequately powered to show statistical significance. Extension period did not include a
placebo comparator and was therefore not designed to draw efficacy conclusions.5
The effects of DAYVIGO at first use were generally consistent with later timepoints.1
Evaluation across subgroups by age, race, sex, and BMI suggested no
differences in response and pharmacokinetics to DAYVIGO.1,7
Studied in a Variety of Patients With Insomnia
Nearly 2000 patients with insomnia disorder participated in the SUNRISE 1 and
SUNRISE 2 clinical trials—multicenter, randomized, double-blind, placebo-controlled trials.1
Polysomnography (sleep labs)
Sleep diaries (patient reports)
N=1006
1-month treatment period
Treatment arms
DAYVIGO 5 mg
DAYVIGO 10 mg
Active comparator (zolpidem ER 6.25 mg)
Placebo
Males ≥65 years of age
Females ≥55 years of age
Median age: 63.0 years
86.0% female
73.0% white
45.0% ≥65 years of age
Sleep diaries (patient reports)
N=971
6-month placebo-controlled treatment period with
6-month parallel-group extension period
Treatment arms
DAYVIGO 5 mg
DAYVIGO 10 mg
Placebo
Adults ≥18 years of age
Median age: 55.0 years
68.0% female
71.5% white
28.0% ≥65 years of age
All patients received instructions consistent with principles of good sleep hygiene.2,3
The SUNRISE pivotal trials:
• Studied insomnia disorder using the most recent DSM-5 diagnostic criteria, including2-4:
- Difficulty initiating, maintaining, or returning to sleep 3 days/week for at least 3 months
- A complaint of clinically significant daytime impairment despite adequate opportunity
for sleep
• Included patients with diverse medical histories or who had medical conditions that
were concurrently treated or controlled for, including5:
• Excluded patients with certain concurrent medical conditions, such as2,3:
sleep-related behaviors
depression or anxiety
References:
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DAYVIGO (lemborexant) [Prescribing Information]. Eisai (HK) Co. Ltd.
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Data on file. CSR 304 Supplemental Tables. Eisai Co., Ltd.
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Data on file. CSR 303 Supplemental Tables. Eisai Co., Ltd.
-
Data on file. CSR 304. Eisai Co., Ltd.
-
Data on file. FSR 303. Eisai Co., Ltd.
-
Data on file. FSR 303 Supplemental Tables. Eisai Co., Ltd.
-
Data on file. ISE. Eisai Co., Ltd.
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Rosenberg R, Murphy P, Zammit G, et al. Comparison of lemborexant with placebo and zolpidem tartrate extended release
for the treatment of older adults with insomnia disorder: a phase 3 randomized clinical trial. JAMA Netw Open.
2019;2(12):e1918254. doi:10.1001/jamanetworkopen.2019.18254. -
Data on file. CSR 303. Eisai Co., Ltd.
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American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American
Psychiatric Association; 2013.