Eisai and Purdue announced that the second Phase 3 study of lemborexant, a potential treatment for sleep-wake disorders, met primary and key secondary efficacy outcomes.
SUNRISE 2 is an ongoing long-term efficacy and safety study (N=900) of adults (aged 18 to 88 years) with insomnia disorder who have difficulty falling and/or staying asleep. The reported data were the primary and key secondary outcomes from the 6-month, placebo-controlled treatment period; the study is continuing up to 1 year.
At the end of the placebo-controlled treatment period (month 6), treatment with lemborexant 5mg and 10mg resulted in a statistically significant improvement in subjective sleep onset latency vs placebo (primary endpoint), as assessed by patient sleep diaries. Both doses of lemborexant also led to a statistically significant improvement in sleep maintenance variables of subjective sleep efficiency and subjective wake after sleep onset vs placebo (key secondary endpoints).
Lemborexant, a dual orexin receptor antagonist, is thought to regulate sleep and wake by counteracting wakefulness without hindering the ability to awaken to external stimuli. Somnolence, headache, and influenza were the most frequent adverse events (>5% incidence in lemborexant arms and greater than placebo). Discontinuation rates were higher in the lemborexant 10mg group vs placebo and lemborexant 5mg groups.
“For me, successful treatment means that patients fall asleep fast, sleep well, and wake well, without functional impairment, or loss of effect over time,” said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the lemborexant studies and former Chairman of the Board of the National Sleep Foundation. “The results of SUNRISE 2 are particularly encouraging for the many patients who suffer from chronic insomnia.”
This article originally appeared on MPR