Officials with the FDA have approved Eisaiâ€™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,"
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."
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