Lemborexant (Dayvigo, Easai Inc) CIV is available in the United States as of June 1 for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. In clinical studies, lemborexant helped some people with insomnia fall asleep faster and stay asleep longer compared with placebo, and the effects of lemborexant at first use were generally consistent with later timepoints.

The FDA approval of lemborexant CIV was based on findings from the lemborexant clinical development program, including 2 pivotal phase 3 studies, SUNRISE 2 and SUNRISE 1. The studies evaluated lemborexant CIV versus placebo and active comparator for up to 1 month and lemborexant CIV versus placebo for 6 months in approximately 2000 adult patients with insomnia.

The most common adverse reaction was somnolence, and further analysis suggests that lemborexant CIV was not associated with rebound insomnia. There was no evidence of withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to 1 year, according to the clinical trials.

Individuals with a history of abuse or addiction to alcohol or other drugs may be at an increased risk for abuse and addiction to lemborexant CIV, and such patients should be monitored carefully.

The recommended dosage of lemborexant CIV is one 5 mg tablet taken no more than once per night, immediately before going to bed with at least 7 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.

Eisai announces US availability of DAYVIGO® (lemborexant) CIV, a new treatment option for adults with insomnia [news release]. Woodcliff Lake, NJ; PR Newswire: June 1, 2020. https://www.prnewswire.com/news-releases/eisai-announces-us-availability-of-dayvigo-lemborexant-civ-a-new-treatment-option-for-adults-with-insomnia-301068256.html. Accessed June 2, 2020.