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Dosage & Administration

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.

Dosage Strength

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
Recommended Dosage

Recommended Dosage1

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.
BMl=body mass index.
Dose Adjustment Dose Adjustment
No Adjustment Use 5 Mg Only Not Recommended
Pediatrics
Geriatrics
Hepatic Impairment Mild
Moderate
Severe
Renal Impairment
CYP3A Inhibitors Weak
Moderate
Strong
CYP3A Inducers Weak
Moderate
Strong

Use with CYP3A inhibitors or CYP3A inducers

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

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.
Recommended Dosage

Set patient expectations1

Recommend an appropriate trial period

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 hygiene

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

See the results

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

See the Transition Study

TRANSITION STUDY2

Evaluating Next-Dose Transition From Zolpidem to DAYVIGO

Study Overview:

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

Primary Endpoint

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 Exclusion Criteria

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 Inclusion Criteria

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 Baseline Characteristics (N=53)

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 Design

Study Design

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

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

⁎ Patients did not taper their study entry Zolpidem 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.

§ 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.

∥ 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.

Study Design
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

Safety Assesments Core Period Extension Period
DAYVIGO5 mg*( n=36) DAYVIGO10 mg*( n=37) DAYVIGO5 mg*( n=32) DAYVIGO10 mg*( n=37)
Treatment-related TEAEs, n 2 10 0 9
TEAE leading to study drug discontinuation 2 5 0 1
TEAEs with incidence >5% in either cohort 1 or 2, n
Abnormal Dreams 0 4 0 2
Somnolence 1 3 0 3
Conjunctival hemorrhage 0 1 0 1
Sinusitis - - 0 1
ECG - QT prolongation 1 0 1 0
Accidental overdose 2 0 - -
Intentional overdose 1 1 - -
Product admin error 0 1 1 0

Core Period

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 Period

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

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

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.

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

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

§Two patients experienced more than 1 AE.

References:

  1. Dayvigo (Lemborexant) India Prescribing Information: 2021.
  2. Rosenberg R, Kumar D, Perdomo C, Moline M, Malhotra M. Evaluation of Next-Dose Transition from Zolpidem to Lemborexant for the Treatment of Insomnia: A Multicenter Open-label Pilot Study. Neurology 2021; 96(15):1420