Eisai to Present Latest DAYVIGO® (lemborexant) CIV Data at 35th Annual Virtual SLEEP 2021 Meeting
Presentations featuring data evaluating DAYVIGO in insomnia highlighting the impact for appropriate patients
WOODCLIFF LAKE, N.J., June 9, 2021 /PRNewswire/ -- Eisai Inc. the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today new presentations featuring the latest data about the company's insomnia medication DAYVIGO (lemborexant) will be presented at the 35th annual SLEEP 2021 meeting of the Associated Professional Sleep Societies, LLC (APSS). SLEEP is a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS) and which will be held virtually from June 10 to June 13, 2021.
"We look forward to presenting new findings from key DAYVIGO clinical studies that we believe provide key considerations for treating patients with insomnia," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "Since its launch one year ago, DAYVIGO has been an important addition to Eisai's rapidly growing neurology portfolio, and we remain committed to helping insomnia patients especially during COVID may have been impacted."
DAYVIGO (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). DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and /or sleep maintenance. In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with insomnia, it is possible that orexin signaling regulating wakefulness is not functioning normally.
The full list of virtual presentations is included below. All presentations will be available to registered participants via SLEEP 2021 Home – SLEEP Meeting from the start of the meeting. Posters will be displayed 24-hours a day in the ePoster gallery from Friday, June 11 through Tuesday, November 30, 2021.
SLEEP 2021 Presentations
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
WARNINGS AND PRECAUTIONS
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:
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:
Patients with Compromised Respiratory Function:
Worsening of Depression/Suicidal Ideation:
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:
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
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
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.
About Eisai Inc.
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
SOURCE Eisai Inc.