Dayvigo (lemborexant; Eisai) is now available for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
The approval of Dayvigo was based on data from two phase 3 studies (SUNRISE 1 and SUNRISE 2) that enrolled approximately 2000 patients. Its mechanism of action is presumed to be through antagonism of orexin receptors.
Dayvigo is supplied as 5mg and 10mg tablets in 30-count and 90-count bottles. The treatment is taken once per night prior to bedtime; at least 7 hours should remain before the planned time of awakening. The time to sleep onset may be delayed if Dayvigo is taken with or soon after a meal.
Based on the results of safety studies, patients should be cautioned about the potential for middle of the night postural instability, as well as attention and memory impairment. Moreover, patients using the 10mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to Dayvigo.
Patients with a history of drug or alcohol abuse or addiction may be at increased risk for abuse and addiction with Dayvigo, a Schedule IV controlled substance. An assessment of patients following study drug discontinuation (using the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire) showed no evidence of withdrawal effects following cessation of treatment.
“Given up to 30% of adults worldwide report insomnia symptoms and the increase in sleep problems due to the life changes caused by the COVID-19 pandemic environment, it is crucial to offer patients treatment options that may help them fall asleep and stay asleep,” said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the Dayvigo clinical studies and former Chairman of the Board of the National Sleep Foundation. “Dayvigo may be an appropriate treatment option for some of these patients.”
For eligible patients, Eisai is offering a 10-day free trial as well as financial assistance to help patients save on out-of-pocket expenses.
For more information visit dayvigo.com.