Lemborexant (Dayvigo; Eisai Company, Woodcliff, NJ) is now available to prescribe for the treatment of insomnia. Lemborexant was approved the Food and Drug Administration (FDA) in late 2019 and scheduled as a category IV controlled substance by the Drug Enforcement Agency in April 2020. In 2 pivotal phase 3 studies, SUNRISE 2 (NCT02952820) and SUNRISE 1 (NCT02783729), lemborexant was effective in decreasing insomnia severity, shortening the time to falling asleep, and decreasing nighttime wakefulness compared to placebo. Approximately one-third of clinical trial participants had a decrease in insomnia to subclinical levels.
Lemborexant was generally safe and well tolerated, with somnolence being the most common adverse event. Analyses also suggested lemborexant was not associated with rebound insomnia or withdrawal effects following treatment discontinuation after use for up to 1 year, suggesting it does not produce physical dependence. With the 5 mg dose, no significant impairment in next-morning driving performance was seen in healthy adults, including those over age 55 compared with placebo. Impairment was seen in some participants taking the 10 mg dose and individuals should be cautioned not to drive while being treated with lemborexant until they know how the drug affects them individually.
"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," said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the lemborexant clinical studies and former chairman of the Board of the National Sleep Foundation. "Lemborexant may be an appropriate treatment option for some of these patients."
"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," said Lynn Kramer, MD, chief clinical officer, Neurology Business Group, Eisai. "Lemborexant 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 6-month treatment period in a pivotal clinical study. We are pleased to make lemborexant available to patients in the US."
Nupur Ghoshal, MD, PhD
Ganesh M. Babulal, PhD, OTD, and Catherine M. Roe, PhD
Cyrus A. Raji, MD, PhD; Somayeh Meysami, MD; and Mario F. Mendez, MD, PhD