WOODCLIFF LAKE, N.J., Aug. 24, 2020 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced it will present new DAYVIGO™ (lemborexant) CIV research at the SLEEP 2020 virtual conference, the 34th annual meeting of the Associated Professional Sleep Societies, August 27-30, 2020. DAYVIGO, a dual orexin receptor antagonist, was recently launched in the U.S. for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.1
Highlights include an oral presentation focusing on the long-term efficacy and safety of DAYVIGO in adults ages 65 and older with insomnia disorder from the Phase 3 clinical study, SUNRISE 2, in which patients were evaluated for up to 12 months. Additional research to be presented will explore sleep onset and sleep maintenance responder profiles over 12 months of treatment with DAYVIGO, efficacy and safety of DAYVIGO in females of perimenopausal age with insomnia disorder, and impact of DAYVIGO treatment on fatigue severity. In addition, interim results from a multi-center pilot study evaluating the next-dose transition from zolpidem to DAYVIGO for the treatment of insomnia will be presented.
"We look forward to sharing new findings about safety and efficacy of DAYVIGO in specific patient populations, particularly those related to its long-term impact in individuals 65 years and older, at SLEEP 2020," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai. "These findings will provide key considerations for addressing insomnia in specific patient populations. Insomnia affects millions of people in the United States.2 This research is especially relevant now, as we know life changes due to the COVID-19 pandemic are causing increased sleep problems."3
Eisai's research to be presented at SLEEP 2020 includes:
- Oral O-01 (0474): Long-Term Efficacy and Safety of Lemborexant in Elderly Adults with Insomnia Disorder: Results from SUNRISE-2
- Poster 473: Effectiveness and Safety of Lemborexant in Subjects Previously Treated with Placebo for 6 Months in SUNRISE-2
- Poster 477: Characteristics of Insomnia Subjects Screened for Transitioning From Zolpidem Tartrate to Lemborexant in a Multicenter Pilot Study
- Poster 478: A Multicenter Open-Label Pilot Study to Evaluate Next-Dose Transition from Zolpidem to Lemborexant for the Treatment of Insomnia
- Poster 479: Sleep Onset and Sleep Maintenance Responder Profiles Over 12 Months of Treatment with Lemborexant: Results from SUNRISE-2
- Poster 480: Efficacy and Safety of Lemborexant In Female Subjects of Perimenopausal Age with Insomnia Disorder
- Poster 481: Impact of Lemborexant on Fatigue Severity in Subjects With Clinically Significant Levels of Fatigue at Baseline
- Poster 484: How Much Improvement In Subject-Reported Sleep Onset Latency Is Needed for Patients to Report a Positive Impact of Their Insomnia Medication?
- Poster 486: Impact of Intrinsic Factors on Efficacy of Lemborexant: Subgroup Analyses of SUNRISE-2
"SLEEP 2020 is particularly exciting for Eisai as we recently launched DAYVIGO for adults with insomnia in the U.S. and Japan and are filing for approval in other countries," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "Eisai has created new digital tools including an online sleep tracker and other patient resources to allow us to serve insomnia patients in a more holistic manner."
[Notes to editors]
1. About Lemborexant
Lemborexant is a small-molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness.2 In individuals with insomnia, it is possible that orexin signaling regulating wakefulness is not functioning normally.
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
- 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. Reevaluate 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.
- 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).
- 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.
2. About Insomnia
Population studies show that sleep disorders affect many more people worldwide than previously thought.2 Insomnia symptoms affect approximately 30% of the adult population worldwide.4 Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep.5
Diagnostic criteria for insomnia disorder include if the sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral or other important areas of functioning, occurs at least three night per week and is present for at least three months.6
Sleeping well is essential for good health. Studies suggest an optimal sleep duration between seven and eight hours.7
Women are 1.4 times more likely than men to suffer from insomnia.8 Older adults also have a higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.9
3. About SUNRISE 2 (Study 1)1
SUNRISE 2: six-month placebo-controlled treatment trial with a 6-month parallel-group extension period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly. The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset). Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSEF; the proportion of time spent asleep per time in bed) and wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
4. About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
1 Eisai Inc. DAYVIGO Full Prescribing Information. 2019.
2 Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
3 The Harvard Gazette. Insomnia in a pandemic. April 2020. Retrieved at https://news.harvard.edu/gazette/story/2020/04/sleep-problems-becoming-risk-factor-as-pandemic-continues/.
4 Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10.
5 Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
6 American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. Arlington, VA: American Psychiatric Publishing, 2013.
7 Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
8 Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, tenth revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, second edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69:592– 600.
9 Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
SOURCE Eisai Inc.
Type Press Release
Date Released August 24, 2020