Pharmaceutical company Eisai Inc reported on Monday the launch of the US FDA approved DAYVIGO (lemborexant) CIV for the treatment of adults with insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.

Based on findings from two pivotal Phase 3 studies (SUNRISE 2 and SUNRISE 1), the company evaluated DAYVIGO versus placebo and active comparator for up to one month and DAYVIGO versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia.

Eisai added that the DAYVIGO at 5 mg and 10 mg doses did not cause significant impairment in next-morning driving performance in healthy adult or elderly subjects (compared with placebo.

According to the company, the recommended dosage of DAYVIGO is one 5 mg tablet taken no more than once per night, immediately before going to bed, with at least seven 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.

Lemborexant is a small-molecule compound, discovered and developed by company in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.