SUNRISE 1 and SUNRISE 2 evaluated the safety of DAYVIGO
Adverse reactions reported in ≥2% of DAYVIGO-treated patients and at a greater frequency than placebo-treated
patients during the first 30 days.1
abdominal dreams
(n=528)
(n=580)
(n=582)
*Combines preferred terms: somnolence, lethargy, fatigue, and sluggishness.
Studies suggested that chronic DAYVIGO use
did not produce
physical dependence1
•
At either dose of DAYVIGO, there was no evidence of withdrawal
effects upon drug discontinuation through 1 year of use, suggesting
no physical dependence
-
Individuals with a history of abuse or addiction to alcohol or other
drugs may be at an increased risk for abuse and addiction to
DAYVIGO—follow such patients carefully
Most common discontinuation rates due to adverse
reactions in SUNRISE 1 and SUNRISE 2 (the first 30 days)1
Most common discontinuation rates due to adverse
reactions in SUNRISE 2 (the first 6 months)1
Analyses suggested DAYVIGO was not associated
with rebound insomnia
when discontinued1
SPECIAL SAFETY STUDIES
Morning
In 2 randomized, placebo- and active-controlled trials in healthy subjects and
patients with insomnia ≥55 years of age1:
Next-day postural stability1
•No meaningful differences were observed between
DAYVIGO (5 mg or 10 mg) and placebo
SUNRISE 1: Change From Baseline for Body Sway Upon Morning Awakening2
Prespecified Exploratory Endpoints
Full analysis set, extreme values removed.
†A unit body sway is defined as 1/3-degree angle of arc movement of the ataxiameter.
Limitations: Change from baseline of body sway for mean units of body sway for DAYVIGO
5 mg and DAYVIGO 10 mg compared to zolpidem ER and placebo were prespecified
exploratory endpoints. These measurements 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.2
Next-day memory1
•No meaningful differences were observed between
DAYVIGO (5 mg or 10 mg) and placebo
In a randomized, double-blind, placebo- and active-controlled, 4-period crossover study1:
Next-morning driving1
•DAYVIGO (5 mg or 10 mg) did not significantlyimpair the morning driving performance of healthy
volunteers vs those taking placebo (N=48)
Patients using the DAYVIGO 10 mg dose should be cautioned about the potential for
next-morning driving impairment because there is individual variation in sensitivity to DAYVIGO.1
Middle of the Night
In a randomized, placebo- and active-controlled trial in healthy female subjects
≥55 years or male subjects ≥65 years1:
Postural stability1
•Both DAYVIGO doses (5 mg and
10 mg) impaired balance (measured
by body sway) at 4 hours postdose
compared with placebo
Awakening to sound1
•Neither DAYVIGO dose demonstrated
any meaningful differences in patients’
ability to awaken to sound compared
with placebo
Attention and memory1
•DAYVIGO was associated with
dose-dependent worsening 4 hours
postdose on measures of attention and
memory as compared to placebo
Patients should be cautioned about the potential for middle of the night postural instability
as well as attention and memory impairment.1
References:
- DAYVIGO (lemborexant) [Prescribing Information]. Eisai (HK) Co. Ltd.
-
Data on file. CSR 304 Supplemental Tables. Eisai Co., Ltd.
-
Data on file. CSR 304. Eisai Co., Ltd.