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Text Content

This site is intended for US Healthcare Professionals

 * This site is intended for
   US Healthcare Professionals
 * Important Safety Information
 * Full Prescribing Information
 * Patient Site
 * REQUEST A REP

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 * Safety
 * Getting Started
 * About DAYVIGO
 * Resources




× Home Efficacy Safety Getting Started About DAYVIGO Resources
 * Patient Site


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have patients asking about DAYVIGO


GETTING STARTED WITH
DAYVIGO

Ready to prescribe? Here’s how your patients
with insomnia
can get started on DAYVIGO.





HEAR A PEER PERSPECTIVE
ON DAYVIGO

Learn about DAYVIGO from Dr.
Khoury, a leading sleep specialist.

Watch the Video
X




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 DOSAGE1,2

 * 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

 * See the Open-Label Pilot Study


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




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.



SET PATIENT EXPECTATIONS

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%)



ADDITIONAL DATA

Study Design1,2





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



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




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.



Get the Savings Card for Your Patients

DAYVIGO Savings Card


REQUEST A REPRESENTATIVE

FIRST NAME
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Terms and Conditions

Please be advised that the personal information you provide will be used to
satisfy your request to receive information from Eisai Inc. Eisai Inc. ("Eisai"
or "we") operates this website and our Privacy Policy will govern the
collection, use, disclosure and retention of the information you provide here.
Please do not submit any personal information unless you have read and agree
with the terms of that Privacy Policy. Consistent with the Privacy Policy, we
and our service providers may use the personal information you provide to
contact you and send you communications, including about products and services
that may interest you. By clicking Submit below, you agree that you have read,
understand, and agree to these conditions.

In the event that you would like to opt out of receiving further communications,
you can request that you be removed from the Eisai contact list at any time by
clicking on the "Unsubscribe" link found at the bottom of all email
communications from Eisai. See our full Privacy Policy.

Submit


YOUR REQUEST IS IN!

Thank you for reaching out. A representative will connect with you in
1 to 2 business days to help you learn more about DAYVIGO.


WE'RE SORRY!

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later and try again.


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.

--------------------------------------------------------------------------------

Expand Collapse


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.

 * Privacy Policy
 * Legal Notice and Disclaimers
 * Site Map

This site is intended for Healthcare Providers of the United States only.

DAYVIGO® is a registered trademark used by Eisai Inc. under license from Eisai
R&D Management Co., Ltd.

© 2021 Eisai Inc. All rights reserved.

DAYV-US3620 09/2021 us.eisai.com

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