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Help Patients Fall Asleep Faster and Stay Asleep Longer1

DAYVIGO was assessed vs placebo across 2 pivotal trials including nearly 2000 adult patients. Studies measured
sleep onset and maintenance at Month 1 (sleep labs) and Month 6 (patient diaries).

At the proven starting dose of 5 mg, and at 10 mg, DAYVIGO was demonstrated superior to
placebo across 2 pivotal trials.1

SLEEP ONSET

SUNRISE 1 (sleep labs)

DAYVIG0 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 1 (sleep labs)  DAYVIG0 reduced time to sleep onset, as assessed by the primary endpoint (mean* change from baseline in LPS vs placebo at Month 1).1

SUNRISE 2 (patient diaries)

DAYVIG0 reduced time to sleep onset, as
assessed by the primary endpoint (mean* change
from baseline in sS0L vs placebo at Month 6).1

PATIENT DIARIES
(6 Months)1,3

SUNRISE 2 (patient diaries)  DAYVIG0 reduced time to sleep onset, as assessed by the primary endpoint (mean* change from baseline in sS0L vs placebo at Month 6).1

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.

Sunrise 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

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


Sunrise 2

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 placebo.1,3

Sleep Onset (sSOL) Over Time1,3

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)

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 1 (sleep labs)  DAYVIGO reduced WASO, as assessed by the secondary endpoint (mean change from baseline in WASO vs placebo at Month 1).1

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

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

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

Sunrise 1

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

WASO 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


Sunrise 2

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

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)

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 1 (sleep labs)  DAYVIGO increased SEF, as assessed by the secondary endpoint (mean change from baseline in SEF vs placebo at Month 1).1

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

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

SEF=sleep efficiency; sSEF=subjective sleep efficiency.

*For sleep maintenance endpoints (SEF, sSEF), the mean refers to least squares mean.1

Sunrise 1

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

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


Sunrise 2

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

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

Sunrise 2

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 (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

Sleeping

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 to DAYVIGO.1,7

Studied in a Variety of Patients With Insomnia

Nearly 2000 patients with insomnia disorder participated in SUNRISE 1 and
SUNRISE 2—multicenter, randomized, double-blind, placebo-controlled trials.1

1,8Sunrise 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
27.0% non-white
45.0% ≥65 years of age

1Sunrise 2

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
28.5% non-white
28.0% ≥65 years of age

All patients received instructions consistent with principles of good sleep hygiene.8,9

The SUNRISE pivotal trials:

Studied insomnia disorder using the most recent DSM-5 diagnostic criteria, including8-10:

- 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, including7:

Major depressive disorder
Migraines
Menopause
Generalized anxiety disorder
Hypertension
Diabetes

Excluded patients with certain concurrent medical conditions, such as8,9:

Narcolepsy
Reported history of complex
sleep-related behaviors
Sleep-related breathing disorder
Circadian rhythm sleep disorder
Periodic limb movement disorder
Restless leg syndrome
Moderate to severe symptoms of
depression or anxiety
BMI=body mass index; DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.

References:

  1. DAYVIGO (lemborexant) [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc.

  2. Data on file. CSR 304 Supplemental Tables. Eisai Inc., Woodcliff Lake, NJ.

  3. Data on file. CSR 303 Supplemental Tables. Eisai Inc., Woodcliff Lake, NJ.

  4. Data on file. CSR 304. Eisai Inc., Woodcliff Lake, NJ.

  5. Data on file. FSR 303. Eisai Inc., Woodcliff Lake, NJ.

  6. Data on file. CSR 303. Eisai Inc., Woodcliff Lake, NJ.

  7. Data on file. ISE. Eisai Inc., Woodcliff Lake, NJ.

  8. 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.

  9. Data on file. CSR 303. Eisai Inc., Woodcliff Lake, NJ.

  10. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.


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INDICATION

DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • DAYVIGO is contraindicated in patients with narcolepsy.

WARNINGS AND PRECAUTIONS

  • Central Nervous System (CNS) Depressant Effects and Daytime Impairment:
    DAYVIGO can impair daytime wakefulness. CNS depressant effects may persist in some patients up to several days after discontinuing DAYVIGO. Prescribers should advise patients about the potential for next-day somnolence.

    Driving ability was impaired in some subjects taking DAYVIGO 10 mg. Risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or at a higher than recommended dose. If taken in these circumstances, patients should not drive or engage in activities requiring mental alertness.

    Use with other classes of CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of DAYVIGO and concomitant CNS depressants may be necessary when administered together. Use of DAYVIGO with other insomnia drugs is not recommended. Patients should be advised not to consume alcohol in combination with DAYVIGO.

    Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.

  • Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms:
    Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions can occur with DAYVIGO. Prescribers should explain these events to patients.

    Symptoms similar to mild cataplexy can occur with DAYVIGO and can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with identified triggering event (e.g., laughter or surprise).

  • Complex Sleep Behaviors:
    Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. Events can occur in hypnotic-naïve and hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants. Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.

  • Patients with Compromised Respiratory Function:
    The effect of DAYVIGO on respiratory function should be considered for patients with compromised respiratory function. DAYVIGO has not been studied in patients with moderate to severe obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD).

  • Worsening of Depression/Suicidal Ideation:
    Incidence of suicidal ideation or suicidal behavior, as assessed by questionnaire, was higher in patients receiving DAYVIGO than placebo (0.3% for DAYVIGO 10 mg, 0.4% for DAYVIGO 5 mg, and 0.2% for placebo). In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed at any one time. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

  • Need to Evaluate for Comorbid Diagnoses:
    Treatment of insomnia should be initiated only after careful evaluation of the patient. Re-evaluate for comorbid conditions if insomnia persists or worsens after 7 to 10 days of treatment. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or medical disorder and can emerge during the course of treatment with sleep-promoting drugs such as DAYVIGO.

ADVERSE REACTIONS

  • The most common adverse reaction (reported in 5% of patients treated with DAYVIGO and at least twice the rate of placebo) with DAYVIGO was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, 1% for placebo).

DRUG INTERACTIONS

  • CYP3A Inhibitors: The maximum recommended dose of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors. Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors.

  • CYP3A Inducers: Avoid concomitant use of DAYVIGO with moderate or strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

  • Pregnancy and Lactation: There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy. Healthcare providers are encouraged to register patients in the DAYVIGO pregnancy registry by calling 1-888-274-2378. There are no available data on DAYVIGO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Infants exposed to DAYVIGO through breastmilk should be monitored for excess sedation.

  • Geriatric Use: Exercise caution when using doses higher than 5 mg in patients ≥65 years old.

  • Renal Impairment: Patients with severe renal impairment may experience an increased risk of somnolence.

  • Hepatic Impairment: The maximum recommended dose of DAYVIGO is 5 mg in patients with moderate hepatic impairment. DAYVIGO is not recommended in patients with severe hepatic impairment. Patients with mild hepatic impairment may experience an increased risk of somnolence.

DRUG ABUSE AND DEPENDENCE

  • DAYVIGO is a Schedule IV-controlled substance.

  • Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to DAYVIGO, follow such patients carefully.

For more information about DAYVIGO, see full Prescribing Information.