Approximately 30% of adults worldwide have symptoms of insomnia. Dayvigo was approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults and was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following Dayvigo discontinuation at either dose. In addition, the development program included multiple safety studies evaluating effects on postural stability, cognition, driving performance and respiratory safety. This may be an option that gets around the side effects of other insomnia medications such as sleep walking and feeling drowsy the next day.

FDA Approves Dayvigo

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients December 23, 2019 — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin receptor antagonist Dayvigo (lemborexant). Dayvigo was approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults1. In…

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