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Explore The DAYVIGO Experience Explore an interactive series to see
appropriate patients for DAYVIGO


DAYVIGO MECHANISM OF ACTION

DAYVIGO targets the pathway that is thought to
regulate wakefulness in the brain.1,2





DAYVIGO (LEMBOREXANT) IS:

 * A dual orexin receptor antagonist that is thought to treat insomnia by
   blocking orexin signals in the brain that are believed to play a role in
   wakefulness1
 * Believed to help patients fall asleep and stay asleep during the night by
   blocking the orexin pathway—which is thought to suppress the wake drive1,2

DAYVIGO did not interact in vitro* with most targets considered to be
involved in sleep/wake regulation, including3:

 * Binding sites for GABA and benzodiazepines on the GABAα receptor
 * Serotonin
 * Noradrenaline
 * Histamine
 * Acetylcholine
 * Dopamine

GABA=gamma aminobutyric acid.

*Defined as <50% inhibition.


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Watch the DAYVIGO MOA in action



DAYVIGO BLOCKS THE OREXIN PATHWAY

Orexin-producing neurons

Orexin neuron projections
through the brain

Major wake-controlling
neurons expressing
orexin receptors

Orexin

DAYVIGO

OX1R

OX2R

OX1R=orexin 1 receptor;
OX2R=orexin 2 receptor.


REFERENCES:

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

 2. 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.

 3. Beuckmann CT, Suzuki M, Ueno T, Nagaoka K, Arai T, Higashiyama H. In vitro
    and in silico characterization of lemborexant (E2006), a novel dual orexin
    receptor antagonist. J Pharmacol Exp Ther. 2017;362(2):287-295. 

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

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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.


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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.

© 2022 Eisai Inc. All rights reserved.

DAYV-US3984 05/2022 us.eisai.com

AN IMPORTANT MESSAGE
FOR OUR PATIENTS AND
HEALTHCARE PROFESSIONALS


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During the current public health crisis, Eisai Inc. is committed to keeping our
supply chain running safely and supporting those who rely on our medications.

As you explore DAYVIGOHCP.com to learn more about our newest medication, be sure
to take a look at the tools, resources, and financial support we’ve provided to
help you and your patients.

Please see the Resource page for more details.

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WE'VE UPDATED OUR
SAVINGS OFFER!

Eligible patients
can pay as little as
$10
a month.

See offer

Restrictions apply. Not all patients are
eligible. See Terms & Conditions.


DAYV-US4057 Aug 2022