FDA Approves Insomnia Therapy for Adult Patients

Officials with the FDA have approved Eisai’s lemborexant (Dayvigo) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Officials with the FDA have approved Eisai’s lemborexant (Dayvigo) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

The FDA has recommended that lemborexant be classified as a controlled substance, and this recommendation has been submitted to the DEA. The drug will be commercially available following scheduling by the DEA, which is expected to occur within 90 days, according to the company.

The FDA’s approval was based on a robust clinical development program that included 2 pivotal phase 3 studies— Study 1 and Study 2—that evaluated lemborexant versus placebo for up to 1 month, and lemborexant versus placebo for 6 months. In addition to these trials, Eisai conducted a number of studies to further evaluate the safety of lemborexant, including a driving study and a study that assessed the effect of the drug on postural stability and memory performance.

"Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,"2 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, in a prepared statement. "The clinical trials provide evidence that Dayvigo may improve patients' ability to fall asleep and stay asleep."

Study 1 was a 6-month, randomized, double-blind, placebo-controlled, multicenter trial in adult patients age 18 years or older who met DSM-5 criteria for insomnia disorder. Study 2 was a 1-month randomized, double-blind, placebo- and active-controlled, multicenter, parallel-group clinical trial in adult female patients age 55 years and older, and male patients 65 years and older who met DSM-5 criteria for insomnia disorder.

The most common adverse reaction in Study 1 (the first 30 days) and Study 2 was somnolence. The most common adverse reactions leading to discontinuation of lemborexant were somnolence and nightmares.

REFERENCE

U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients [news release]. Woodcliff Lake, NJ and Tokyo, Japan; December 23, 2019: Eisai. https://www.eisai.com/news/2019/news201993.html. Accessed December 24, 2019.