EISAI TO PRESENT LATEST DATA ON LEMBOREXANT AT THE 36TH ANNUAL SLEEP 2022 MEETING
NUTLEY, N.J., June 2, 2022 /PRNewswire/ -- Eisai Inc. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today a total of seven poster presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO® CIV) will be given at the 36th annual meeting of the Associated Professional Sleep Societies (SLEEP 2022), to be held from June 4 to June 8, 2022, in Charlotte, NC.
Major poster presentations include the results of a subgroup analysis of the Phase III 304 clinical study on the effect of lemborexant treatment in older adults with insomnia and objectives of short sleep which is characterized by sleeping fewer than six hours (Posters #171 and #172).
"DAYVIGO continues to serve as an important asset to Eisai's neurology portfolio and we look forward to presenting the findings from several analyses at this year's SLEEP Meeting," said Ivan Cheung, Eisai Inc., Senior Vice President, President Neurology Business Group, Eisai Co., Ltd. "Insomnia can lead to daytime consequences; fatigue, difficulty concentrating and irritability, 1, 2 and causes distress or impairs functioning in social and occupational settings.3 Eisai remains committed to our pursuit of helping people suffering from insomnia to help address unmet medical needs."
SLEEP 2022 Presentations
Please note, the poster presentation time is 5:15 PM – 7:15 PM on Monday, June 6 with odd numbered poster presentations taking place from 5:15 PM – 6:15 PM and even numbered poster presentations from 6:15 PM – 7:15 PM.
Eisai Inc. (U.S.)
[Notes to editors]
About Eisai Co., Ltd.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
About Eisai Inc.
Everything we do is guided by the simple principle that patients and their families come first, and we have a responsibility to listen to and learn from them.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. The company's presence in the U.S. includes three discovery centers as well as commercial, clinical development and global demand organizations. To learn more about Eisai, please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. For more information on our work in neurology, please visit the Eisai U.S. Neurology LinkedIn page.
INDICATION FOR DAYVIGO
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.
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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SOURCE Eisai Inc.
Company Codes: Tokyo:4523, OTC-PINK:ESALY