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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

Adverse Reactions, %
Somnolence
or fatigue*
Headache
Nightmare
or
abnormal dreams
Placebo
(n=528)
1.3%
3.4%
0.9%
DAYVIGO 5 mg
(n=580)
6.9%
5.9%
0.9%
DAYVIGO 10 mg
(n=582)
9.6%
4.5%
2.2%

*Combines preferred terms: somnolence, lethargy, fatigue, and sluggishness.

Chronic Dayvigo Use

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

DAYVIGO contains lemborexant, a Schedule IV-controlled substance

- 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

Discontinuation Due to:
Adverse reactions
Somnolence
Nightmares
Placebo
1.5%
0.4%
0.0%
DAYVIGO 5 mg
1.4%
0.7%
0.3%
DAYVIGO 10 mg
2.6%
1.0%
0.3%

Most common discontinuation rates due to adverse
reactions in SUNRISE 2 (the first 6 months)1

Discontinuation Due to:
Adverse reactions
Somnolence
Nightmares
Palpitations
Placebo
3.8%
0.6%
0.0%
0.0%
DAYVIGO 5 mg
4.1%
1.0%
0.3%
0.0%
DAYVIGO 10 mg
8.3%
2.9%
1.3%
0.6%
DAYVIGO was not associated with rebound insomnia when discontinued.1

Analyses suggested DAYVIGO was not associated with rebound insomnia when discontinued.1

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

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

Safety Sunrise Body Sway Chart

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

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 driving

Next-morning driving1

DAYVIGO (5 mg or 10 mg) did not significantly
impair 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:

Next-day postural stability1

Postural stability1

Both DAYVIGO doses (5 mg and
10 mg) impaired balance (measured
by body sway) at 4 hours postdose
compared with placebo

Next-day memory1

Attention and memory1

DAYVIGO was associated with
dose-dependent worsening 4 hours
postdose on measures of attention
and memory compared with placebo

Awakening to sound

Awakening to sound1

Neither DAYVIGO dose demonstrated
any meaningful differences in patients’
ability to awaken to sound compared
with placebo

Patients should be cautioned about the potential for middle of the night postural instability
as well as attention and memory impairment.1

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 304. Eisai Inc., Woodcliff Lake, NJ.


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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.


SELECTED SAFETY INFORMATION

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.