Eisai Inc, the US pharmaceutical subsidiary of Eisai Co Ltd, has made available DAYVIGO (lemborexant) CIV for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, in the United States. In clinical studies, DAYVIGO helped some people with insomnia fall asleep faster and stay asleep longer compared to placebo. The effects of DAYVIGO at first use were generally consistent with later timepoints.

“Given up to 30% of adults worldwide report insomnia symptoms and the increase in sleep problems due to the life changes caused by the COVID-19 pandemic environment, it is crucial to offer patients treatment options that may help them fall asleep and stay asleep,” says Russell Rosenberg, PhD, DABSM, a principal investigator in the DAYVIGO clinical studies and former chairman of the board of the National Sleep Foundation, in a release. “DAYVIGO may be an appropriate treatment option for some of these patients.”

The US Food and Drug Administration’s (FDA) approval of DAYVIGO was based on findings from the lemborexant clinical development program. This included two pivotal Phase 3 studies (SUNRISE 2 and SUNRISE 1), which evaluated DAYVIGO versus placebo and active comparator for up to one month and DAYVIGO versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia.

The most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence (DAYVIGO 10 mg, 10%; DAYVIGO 5 mg, 7%; placebo, 1%). Analyses suggested DAYVIGO was not associated with rebound insomnia, and there was no evidence of withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to one year.

DAYVIGO at 5 mg and 10 mg doses did not cause significant impairment in next-morning driving performance in healthy adult or elderly subjects (compared with placebo). Impairment was seen in some people taking the 10 mg dose. 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.

On April 7, 2020, the US Drug Enforcement Administration classified DAYVIGO as a Schedule IV drug based on an eight-factor analysis conducted by FDA. Schedule IV drugs are defined as those with a low potential for abuse and low risk of dependence. This scheduling is consistent with that assigned to other medications indicated for the treatment of sleep disorders. Individuals with a history of abuse or addiction to alcohol or other drugs may be at an increased risk for abuse and addiction to DAYVIGO and such patients should be followed carefully.

“Insomnia is often a chronic condition for which patients may require treatment over an extended period of time, so the long-term safety of medications is an important consideration for patients and health care professionals,” says Lynn Kramer, MD, chief clinical officer, Neurology Business Group, Eisai. “DAYVIGO is the first FDA-approved insomnia medication with safety data over a 12-month treatment period and with sleep onset and sleep maintenance efficacy data over a six-month treatment period in a pivotal clinical study. We are pleased to make DAYVIGO available to patients in the US.”

The recommended dosage of DAYVIGO is one 5 mg tablet taken no more than once per night, immediately before going to bed, with at least seven hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal.

“The US is the first country in which DAYVIGO is available, and we are excited by its potential to help patients sleep better,” says Ivan Cheung, chairman, Eisai Inc, and global president, Neurology Business Group, Eisai Co Ltd. “DAYVIGO is an important addition to Eisai’s rapidly growing neurology portfolio, which underscores our leadership in neuroscience. Eisai remains committed to discovering and developing innovative solutions to unmet medical needs that benefit patients and their families.”

Lemborexant is presumed to inhibit orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). Orexin signaling is believed to promote periods of wakefulness. In individuals with insomnia, it is possible that orexin signaling that regulates wakefulness is not functioning normally.