Dayvigo (lemborexant) is an orexin receptor antagonist.
Dayvigo is specifically indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.
Dayvigo is supplied as a tablet for oral administration. The recommended dosage of Dayvigo is 5 mg 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. Time to sleep onset may be delayed if taken with or soon after a meal. Please see drug label for specific dose modifications.
The FDA approval of Dayvigo was based on two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated Dayvigo versus comparators for up to one month and Dayvigo versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia.
The most common adverse effect associated with the use of Dayvigo was somnolence.
The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
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