Dayvigo Overview | Eisai Pro
This website is only for healthcare professionals licensed by the Ministry of Health in Israel
Dayvigo_Brand_Logo

DAYVIGO® is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

DAYVIGO® is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

DAYVIGO® Mechanism of Action

DAYVIGO® is a dual orexin receptor antagonist1

• Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive1*
• DAYVIGO® works differently from sedatives which enhance sleep-promoting effects through increased GABA activity2
• DAYVIGO® blocks orexin activity at night, counteracting inappropriate wakefulness.2

Pre-clinical-data

Efficacy

Effects of DAYVIGO® on sleep onset

DAYVIGO® begins working from the first two nights, and maintains its effectiveness over time3,4
Time to sleep onset decreased significantly in patients treated with DAYVIGO® compared to placebo and zolpidem.3

FIGURE 1: Mean change from baseline in Latency to Persistent Sleep

dayvigo_sunrise_img
Adapted from Rosenberg et al 2019
Assessed by polysomnography. Outcomes assessed at nights 1 and 2 and nights 29 and 30. Due to non-normal distribution of latency to persistent sleep, the values were log-transformed and the geometric mean ratio used to test for statistically significant treatment differences.3

SUNRISE 1 study design: Randomised, placebo-controlled trial in 1006 patients with insomnia disorder aged 55 and over. Patients received either placebo, zolpidem tartrate extended release 6.25 mg, or DAYVIGO® 5 mg or 10 mg for one month at bedtime. The primary endpoint was change from baseline in latency to persistent sleep for lemborexant therapy vs placebo using polysomnography (PSG). Key secondary endpoints included sleep efficiency and Wake After Sleep Onset (WASO) compared with placebo and WASO in the second half of the night (WASO2H) compared with zolpidem therapy.3

The benefits of DAYVIGO® are maintained through to 12 months4

DAYVIGO® significantly reduced time to sleep onset from week 1 to month 6, and its effect was maintained over 12 months.4

FIGURE 2: Mean change from baseline in subjective Sleep Onset Latency4

Assessed by electronic sleep diary, *p<0.0001;  ‡ p<0.01, p values based on the mixed-effect model repeated measurement analysis evaluating the least square mean treatment ratio vs placebo for the first six-month treatment period.

Effects of DAYVIGO® on sleep maintenance


DAYVIGO® significantly reduces time awake after sleep onset (WASO)3

The reduction in WASO in the second half of the night (WASO2H) from baseline was significantly greater with DAYVIGO® compared with placebo and zolpidem.3

*LSM Change from baseline in wake-sfter-sleep-onset in the second half of the night (WASO2H) asesses by polysomnography3

LSM_change_from-01
Adapted from Rosenberg et al 2019
SUNRISE 1 study design: Randomised, placebo-controlled trial in 1006 patients with insomnia disorder aged 55 and over. Patients received either placebo, zolpidem tartrate extended release 6.25 mg, or DAYVIGO® 5 mg or 10 mg for one month at bedtime. The primary endpoint was change from baseline in latency to persistent sleep for lemborexant therapy vs placebo.3

Safety and Tolerability

DAYVIGO® is generally well-tolerated1

The safety of DAYVIGO® was evaluated in 1418 adult patients with insomnia disorder (age 18-88 years) from two controlled efficacy trials (Study 303 and Study 304). Study 303 was a 6-month placebo-controlled trial assessing DAYVIGO® 5 or 10mg nightly followed by a 6 month parallel-group extension period. In study 303, 434 patients were treated with DAYVIGO® for one year. Study 304 was a 30-day placebo-and active-controlled trial assessing DAYVIGO® 5 or 10mg nightly.1

The most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at least twice the rate of placebo) in Study 303 (the first 30 days) and Study 304 was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, and 1% for placebo).

Table1: Adverse reactions reported in ≥2% of DAYVIGO®-treated patients and at a greater frequency than placebo- treated patients1. During the First 30 Days of Study 303 and Study 304

adverse_reactions_reported

  • other_adverse_reactions_ico

    Other adverse reactions

    Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, can occur with the use of DAYVIGO®. In clinical trials, DAYVIGO® was associated with sleep paralysis: DAYVIGO® 5 mg 1.3% or DAYVIGO® 10 mg 1.6% compared to no reports for placebo. Two events of complex sleep behaviour were reported, both in patients receiving DAYVIGO® 10 mg.1

  • rebound_insomnia_ico

    Rebound insomnia

    Rebound insomnia was assessed by comparing sleep diary-recorded subjective sleep onset latency (sSOL) and subjective wake-after-sleep-onset (sWASO) from the screening period to the two weeks following treatment discontinuation in both Study 303 (12 months) and Study 304 (1 month). Analyses of group means and the proportion of patients with rebound insomnia suggest that DAYVIGO® was not associated with rebound insomnia following treatment discontinuation.1

  • capsule

    Withdrawal effects

    In 12-month and 1-month controlled safety and efficacy trials (Studies 303 and 304, respectively), withdrawal effects were assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire following discontinuation from study drug in patients who received DAYVIGO® 5 mg or 10 mg. There was no evidence of withdrawal effects following DAYVIGO® discontinuation at either dose.1

  • postural_stability_img-1

    Postural stability

    There were no meaningful differences between DAYVIGO® and placebo on next-day postural stability (patients 55 and older). The effect of DAYVIGO® on next-day postural stability compared to placebo was evaluated in 2 randomised, placebo-controlled clinical studies.1,5

  • car_img_icon

    Driving

    DAYVIGO® at doses of 5 mg and 10 mg did not cause statistically significant impairment in next morning driving performance in adult or elderly subjects (compared with placebo).6 However, driving ability was impaired in some subjects taking 10 mg DAYVIGO®. Patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to DAYVIGO®.1

  • Memory image

    Memory

    DAYVIGO® was found to have no significant effects on cognitive performance compared to placebo.7

    Healthy women (≥ 55 years) and men (≥ 65 years) were randomised, double-blind, to 1 of 4-period, single-dose crossover sequences, starting with lemborexant 5 mg (LEM5), 10 mg (LEM10), zolpidem (ZOL), or placebo (PBO). A ≥14-day washout followed all 4 treatments. Assessments were middle-of-the-night (MOTN) change from baseline in postural stability (primary prespecified comparison: LEM vs ZOL), AAT*, absolute AAT, and CPAB* for LEM5 and LEM10 versus ZOL and PBO; and morning change from baseline in postural stability and CPAB for LEM5 and LEM10 versus ZOL and PBO. Change from baseline measures were time-matched to a baseline night/morning when no study drug was administered.7

Dosing and Administration


Starting dose

The recommended dosage of DAYVIGO is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening.1

Increasing the dose

The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.1

  • pro-image-5mg

  • pro-image-10mg

Important points about DAYVIGO®1

chicken_ico

Time to sleep onset may be delayed if taken with or soon after a meal.

drink

Patients should be advised not to consume alcohol in combination with DAYVIGO®.

7 Day

There were no meaningful differences between DAYVIGO® (5 mg or 10 mg) and placebo on next day postural stability or memory (patients 55 years and older)

7 Hour

Patients should be sure to take their DAYVIGO® at least 7 hours before they plan to wake up to reduce the risk of daytime impairment occuring.

Additional information1

Like other orexin receptor antagonists, DAYVIGO® is contraindicated in patients with narcolepsy.1
DAYVIGO® is also contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.1
Avoid concomitant use of DAYVIGO® with moderate or strong CYP3A inhibitors.1
The maximum recommended dose of DAYVIGO® with weak CYP3A inhibitors is 5 mg.1
DAYVIGO® is not recommended in patients with severe hepatic impairment.1
Avoid concomitant use of Dayvigo with moderate or strong CYP3A inducers.1

Co-administration of DAYVIGO with other CNS depressants increases the risk of CNS depression1

CNS depression can cause daytime impairment.
Dosage adjustments of DAYVIGO® and of concomitant  CNS depressants may be necessary when administered together because of potentially additive effects.
CNS depressant effects may persist in some patients for up to several days after discontinuing DAYVIGO®.

Examples of CNS depressants:
  • Cup

    Alcohol

  • Benzodiazepines

    Benzodiazepines

  • Opioids

    Opioids

  • Tricyclic antidepressants

    Tricyclic antidepressants

The use of DAYVIGO® with other drugs to treat insomnia is not recommended.1

For all Special Warnings and Precautions For Use, please refer to Dayvigo® SPC as approved by the Israeli MOH

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeects.health.gov.il/ or emailed to Eisai Israel at: eir_pv@eisai.net

For full information please refer to Dayvigo® SPC as approved by the Israeli MOH

AAT, Auditory awakening threshold; CPAB, Cognitive performance assessment battery; ISI, Insomnia Severity Index; LSM, least squares mean; PSG, Polysomnography; SD, standard deviation; WASO, wake-after-sleep onset; MedDRA, Medical Dictionary for Regulatory Activities
  • 1. DAYVIGO® (lemborexant) SPC as approved by the Israeli MOH
  • 2. Beuckmann CT et al. J Pharmacol Exp Ther 2017;362(2):287-95.
  • 3. Rosenberg R, et al. JAMA Network Open 2019; 2 (12): e1918254.
  • 4. Yardley J, et al. Sleep Med 2021; 80: 333–342.
  • 5. Moline M, et al. Postgrad Med 2021;133(1):71-81.
  • 6. Vermeeren A, et al. Sleep. 2019;42(4):zsy260.
  • 7. Murphy, P et al. J Clin Sleep Med. 2020;16(5):765–773.

Date of preparation:

Promomats ref:

August 2024

IL-DAY-24-00026

Date of preparation:

August 2024

Promomats ref:

IL-DAY-24-00026

Therapy areas

Select your area of interest

External Link

You are leaving Eisai

You are being redirected to an external site. Would you like to leave this site?

Continue
Eisai Pro

This page contains medical information

You are navigating from a page, which contains promotional content to a page that contains purely medical information.