Eisai announced the U.S. Food and Drug Administration (FDA) approved DAYVIGO™ (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on a robust clinical development program that included two pivotal Phase 3 studies, which evaluated DAYVIGO versus placebo for up to one month and DAYVIGO versus placebo for six months. The FDA has recommended that DAYVIGO be classified as a controlled substance, and this recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA). DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
"Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being," 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. "The clinical trials provide evidence that DAYVIGO may improve patients' ability to fall asleep and stay asleep."
The most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at least twice the rate of placebo) in Study 1 (the first 30 days) and Study 2 was somnolence (DAYVIGO 10 mg, 10%; DAYVIGO 5 mg, 7%; placebo, 1.0%). The most common adverse reactions leading to discontinuation of DAYVIGO were somnolence (DAYVIGO 10 mg, 1.0%; DAYVIGO 5 mg, 0.7%; placebo, 0.4%) and nightmares (DAYVIGO 10 mg, 0.3%; DAYVIGO 5 mg, 0.3%; and placebo, 0%).
The FDA approval was based on findings from the lemborexant clinical development program, including two pivotal Phase 3 studies – Study 1 and Study 2.
Study 1 was a six-month, randomized, double-blind, placebo-controlled, multi-center trial in adult patients age 18 or older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly. The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for log-transformed, patient-reported (subjective) sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset). Pre-specified secondary efficacy endpoints for sleep maintenance were change from baseline to end of treatment at six months for patient-reported sleep efficiency (sSEF; the proportion of time spent asleep per time in bed) and wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). The primary and pre-specified secondary efficacy endpoints were measured by sleep diary. In Study 1, DAYVIGO 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, sSOL, compared to placebo. DAYVIGO 5 mg and 10 mg also showed statistically significant superiority in sSEF and sWASO.
Study 2 was a one-month randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), DAYVIGO 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly. The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring. The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG. In Study 2, DAYVIGO 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. DAYVIGO 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.
The effects of DAYVIGO at the beginning of treatment were generally consistent with later timepoints.
In 12-month and one-month controlled safety and efficacy trials (Studies 1 and 2, respectively), DAYVIGO was not associated with rebound insomnia following treatment discontinuation. Withdrawal e...
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