Filorexant(MK-6096)是一种食欲素受体拮抗剂;在这里,我们评估了filorexant治疗成人失眠的疗效。
双盲,安慰剂对照,随机化,两个4周的时间,自适应交叉多导睡眠图研究在全球51个地点进行.失眠症患者(18至<65岁)在一个时期的就寝时间每天接受一次4种剂量的口腔丝素(2.5、5、10、20mg)中的1种,在另一个时期的8种可能的治疗顺序中的1种。在每个周期的第1晚和第4周结束时进行多导睡眠图。主要终点是第1晚和第4周结束时的睡眠效率。次要终点包括持续睡眠发作后的觉醒和持续睡眠发作的潜伏期。
共有324名患者接受了研究治疗,315接受≥1剂安慰剂,和318≥1剂量的filorexant(2.5mg,n=79;5mg,n=78;10mg,n=80;20mg,n=81)。通过在第1晚和第4周结束持续睡眠后的睡眠效率和清醒度来衡量,所有filorexant剂量(2.5/5/10/20mg)在改善失眠患者的睡眠方面均显着优于安慰剂。2种更高的filorexant剂量(10/20mg)在改善睡眠发作方面也比安慰剂明显更有效,这是通过在第1晚和第4周结束时持续睡眠开始的潜伏期来衡量的。Filorexant通常具有良好的耐受性。
非老年失眠患者的食欲素受体拮抗作用能显著改善睡眠效率。使用filorexant还观察到睡眠发作和维持结果的剂量相关改善。
Filorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults.
A double-blind, placebo-controlled, randomized, two 4-week-period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.5, 5, 10, 20mg) once daily at bedtime during one period and matching placebo in the other period in 1 of 8 possible treatment sequences. Polysomnography was performed on night 1 and end of week 4 of each period. The primary endpoint was sleep efficiency at night 1 and end of week 4. Secondary endpoints included wakefulness after persistent sleep onset and latency to onset of persistent sleep.
A total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5mg, n=79; 5mg, n=78; 10mg, n=80; 20mg, n=81). All filorexant doses (2.5/5/10/20mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency and wakefulness after persistent sleep onset on night 1 and end of week 4. The 2 higher filorexant doses (10/20mg) were also significantly more effective than placebo in improving sleep onset as measured by latency to onset of persistent sleep at night 1 and end of week 4. Filorexant was generally well tolerated.
Orexin receptor antagonism by filorexant significantly improved sleep efficiency in nonelderly patients with insomnia. Dose-related improvements in sleep onset and maintenance outcomes were also observed with filorexant.