Getting Started BannerGetting Started With DAYVIGO Ready to prescribe? Here’s how your patients with insomnia can get started on DAYVIGO.
Dr Khoury

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on DAYVIGO

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Khoury, a leading sleep specialist.

A Proven Once-Daily Starting Dose of 5 mg1

DAYVIGO is a dual orexin receptor antagonist with convenient dosing, once nightly right before bed,
with at least 7 hours remaining before planned awakening.1

Recommended 5mg dosage
  • The recommended starting dose of DAYVIGO is 5 mg
  • The dose may be increased to the maximum recommended dose of 10 mg, based on
    clinical response and tolerability
  • No need for dose adjustment based on age, sex, BMI, and renal impairment
    • Exercise caution when using 10 mg in patients ≥65 years of age
    • Patients with severe renal impairment may experience an increased risk of
      somnolence
  • For patients with moderate hepatic impairment, the maximum recommended dose is
    5 mg once per night. DAYVIGO is not recommended for patients with severe hepatic
    impairment
    • Patients with mild hepatic impairment may experience an increased risk of
      somnolence

Use with CYP3A inhibitors or CYP3A inducers1

  • Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors
    and inducers
  • When coadministered with weak CYP3A inhibitors, the maximum recommended dose
    of DAYVIGO is 5 mg, no more than once per night

See the Results

Learn about a study that evaluated transition from a commonly prescribed insomnia medication to DAYVIGO

Administering DAYVIGO

Administration1

  • DAYVIGO should be taken immediately before going to bed and with at least 7 hours
    remaining before the planned time of awakening
  • DAYVIGO should not be taken more than once per night
  • Time to sleep onset may be delayed if taken with, or soon after, a meal
Available 5mg and 10mg dosage

Dosage strengths1

  • DAYVIGO tablets are available in 2 strengths:
    • 5 mg tablets: pale yellow, round, biconvex, film-coated tablets, and debossed with
      "5" on one side and "LЄM" on the other side
    • 10 mg tablets: orange, round, biconvex, film-coated tablets, and debossed with "10"
      on one side and "LЄM" on the other side
BMl=body mass index.
Patient Information

Recommend an appropriate trial period1

  • Your patients may feel differently when they fall asleep while taking DAYVIGO than
    their previous experience or expectations
  • It’s important to give DAYVIGO an appropriate trial period of 7 to 10 days as it may
    take a few days to assess patient response
  • If insomnia persists after 7 to 10 days of treatment, reassess for comorbid conditions

Counsel your patients on good sleep hygiene3

In addition to treatment, patients may benefit from improving their sleep
hygiene—habits that can help them optimize sleep. Some examples can include:

  • Limit daytime napping
  • Exercise
  • Avoid foods that trigger indigestion
  • Have a regular bedtime routine
  • Ensure adequate exposure to natural light
  • Establish a pleasant sleep environment
  • Avoid stimulants (such as caffeine and nicotine) close to bedtime

TRANSITION STUDY

Evaluating Next-Dose Transition
From Zolpidem to DAYVIGO1

Study Overview: An open-label pilot study to assess the dosing approach of directly
transitioning from zolpidem (Zol) to DAYVIGO 5 mg or 10 mg1,2

Primary Endpoint1

Proportion of overall patients who transitioned from Zol to DAYVIGO 5 mg or 10 mg at the end of core period, and either:
-Entered the extension period -Chose not to enter for reasons unrelated to DAYVIGO

Selected Inclusion Criteria1

Adults (≥18 years of age) who met the DSM-5 criteria for insomnia disorder, either currently or prior to Zol use

Reported spending ≥7 hours in bed/night

History (≥1 month) of intermittent use (3-4 times per week) or frequent use (≥5 times per week) of Zol-IR or Zol-ER*

Selected Exclusion Criteria1

Narcolepsy

Current diagnosis of complex sleep-related behaviors

Sleep-related breathing disorder, excluding mild OSA

Circadian rhythm sleep disorder

Periodic limb movement disorder

Restless leg syndrome

Selected Baseline Characteristics (N=53)1

Basic Demographics

Mean age (SD): 59.0 years (12.2)

Female: n=35 (66.0%)

Non-white: n=12 (22.6%)

Prior Zol Experience

Mean Zol time use (SD): 4.9 years (4.2)

Zol-IR: n=52 (98.1%)

Zol-ER: n=6 (11.3%)

Study Design1,2


Study design chart study design

The recommended starting dose of DAYVIGO is 5 mg, taken once per night right before bed.3

ER=extended release; IR=immediate release; R=randomization; Zol=zolpidem tartrate.


Patients did not taper their study entry Zol dose.

Follow-up visit occurred 4 weeks after completion of the core period (or as soon as possible following early discontinuation) for patients who did not enter the extension period.

Follow-up visit occurred 4 weeks after last dose of DAYVIGO for those who completed or discontinued during the extension period.2

§History (≥1 month) of intermittent (3-4 times/week) or frequent (≥5 times/week) use of Zol-IR (max 10 mg/night) or Zol-ER (max 12.5 mg/night), and not taking a dose that was lower than what was prescribed.1

Patients who met both criteria for intermittent and frequent Zol use for 1 week each of the last 2 weeks of the 3-week screening period were assigned to cohort 1 and referred to as cohort 1-mixed.1


References: 1. Eisai Inc. Data on file (Study 312 Core), March 2020. 2. Eisai Inc. Data on file (Study 312 Extension), June 2020. 3. DAYVIGO (lemborexant). Prescribing information. Eisai Inc.; 2020.



Study Results for Transition From Zolpidem to DAYVIGO1,2


study result
study result mobile

All patients who transitioned to DAYVIGO at the end of the core period chose to enter the extension period.2

2 of 43 patients entered extension period but discontinued prior to the first dose of the extension period

Patients who completed the entire study (core and extension period) were on DAYVIGO for a total of ~3.5 months after discontinuing Zol.1,✝

Limitations

This was an open-label, pilot study

Assessed only a specified approach to dosing transition

The study was not designed or powered for efficacy and safety statistical comparisons between DAYVIGO and Zol or between the treatment arms

AE=adverse event; Zol=zolpidem tartrate.

Of the patients who entered and received treatment during extension period, 9 were in cohort 1 and 32 were in cohort 2.

Patients were allowed to select the days they wanted to take a dose.

References: 1. Eisai Inc. Data on file (Study 312 Core), March 2020. 2. Eisai Inc. Data on file (Study 312 Extension), June 2020.


Overview of Treatment-Emergent
Adverse Events in Open-Label Study


overview treatment emergent mobile overview of treatment-emergent

Core Period1

No deaths or treatment-emergent SAEs were reported

7 patients discontinued due to AEs§: Diarrhea, nausea, intentional overdose (not suicidal), sedation, cataplexy, hemiplegia, paralysis, sleep paralysis, abnormal dreams, anxiety
-All 7 patients recovered after discontinuing treatment


Extension Period2

1 patient discontinued due to a serious AE related to the symptoms of COVID-19


Safety profile for subjects transitioning from Zol to DAYVIGO was consistent with the known safety profile of DAYVIGO based on the Clinical Development Program.1,2


AE=adverse event; COVID-19=coronavirus disease 2019; ECG=electrocardiogram; SAE=serious adverse event; TEAE=treatment-emergent adverse event; Zol=zolpidem tartrate.

On-treatment dose, ie, dose taken at the time of AE.1

TEAEs considered by the investigator to be related to study drug or TEAEs with missing causality.1

Both patients were recorded as having intentional overdose to improve sleep and were declared to be mild in severity and nonserious.1

§Two patients experienced more than 1 AE.1

References: 1. Eisai Inc. Data on file (Study 312 Core), March 2020. 2. Eisai Inc. Data on file (Study 312 Extension), June 2020.

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References:

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

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

  3. Sleep hygiene. National Sleep Foundation website. https://www.sleepfoundation.org/articles/sleep-hygiene. Accessed November 11, 2019.


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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.