Key results from two phase 3 trials on the efficacy and safety of daridorexant in patients with chronic insomnia

IF 0.6 Q4 CLINICAL NEUROLOGY

Future Neurology Pub Date : 2023-05-04 DOI:10.2217/fnl-2022-0014

E. Mignot, D. Mayleben, I. Fietze, D. Léger, G. Zammit, Claudio L A Bassetti, D. S. Kinter, T. Roth

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Abstract

This plain language summary describes the main results from two similar research studies, “Study 1” and “Study 2”, which evaluated the use of a medication called daridorexant in patients with chronic insomnia disorder. These two studies were phase 3 clinical trials, which compared different doses of daridorexant to an inactive pill called a placebo, which looked and tasted similar to the daridorexant pill but did not contain daridorexant or any other active ingredient. Adults with chronic insomnia disorder typically find it hard to fall or stay asleep and may wake up too early, leading to sleep dissatisfaction. They also have impaired daytime functioning, which is when a person can feel tired or drowsy, have difficulty concentrating, or experience low mood as a consequence of lack of sleep. Adults with chronic insomnia disorder are also at increased risk for injuries and accidents as a result of that impaired daytime functioning. Researchers found that daridorexant 50 mg and 25 mg improved on average participants' ability to get to sleep and stay asleep, as well as increasing their overall total sleep time. Daridorexant 50 mg also improved daytime functioning without any negative effects the next morning, such as feeling tired or drowsy, on average in the participants included in the studies. While available medications are effective in treating night-time symptoms of insomnia, they have not been shown to improve daytime symptoms in insomnia, and in many cases have been shown to have residual effects the next day due to their nature as sedatives. Therefore there has been a need for new treatments for chronic insomnia disorder that will improve both night-time and daytime symptoms with minimal next morning effects. These findings show the effectiveness of daridorexant 50 mg in improving both night-time and daytime functioning, and that daridorexant is well-tolerated at all doses. The results from these two studies resulted in the approval of the 25 mg and 50 mg doses of daridorexant by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Clinical Trial Registration: NCT03545191 (study 1) and NCT03575104 (study 2) ( ClinicalTrials.gov )

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daridorexant对慢性失眠症患者的疗效和安全性的两项3期试验的关键结果

这份简明的摘要描述了两项类似研究的主要结果，“研究1”和“研究2”，这两项研究评估了一种名为daridorexant的药物在慢性失眠患者中的使用情况。这两项研究是3期临床试验，将不同剂量的达里多沙与一种名为安慰剂的无活性药丸进行了比较，安慰剂的外观和味道与达里多萨药丸相似，但不含达里多西或任何其他活性成分。患有慢性失眠障碍的成年人通常会发现很难入睡或保持睡眠，而且可能醒得太早，导致睡眠不满意。他们的日间功能也会受损，即一个人可能会感到疲劳或嗜睡，难以集中注意力，或因睡眠不足而情绪低落。患有慢性失眠障碍的成年人由于日间功能受损，受伤和事故的风险也会增加。研究人员发现，50毫克和25毫克的daridorexant平均能提高参与者的睡眠和保持睡眠的能力，并增加他们的总睡眠时间。参与研究的参与者平均而言，50 mg Daridorexant也改善了白天的功能，第二天早上没有任何负面影响，比如感到疲劳或嗜睡。虽然现有的药物对治疗失眠的夜间症状有效，但它们并没有被证明能改善失眠的日间症状，而且在许多情况下，由于其作为镇静剂的性质，它们在第二天会产生残留影响。因此，需要一种新的治疗慢性失眠的方法，这种方法可以改善夜间和白天的症状，第二天早上的影响最小。这些发现表明，50 mg的daridorexant在改善夜间和日间功能方面是有效的，并且Daridorexent在所有剂量下都具有良好的耐受性。这两项研究的结果导致美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准了25毫克和50毫克剂量的达里多列。临床试验注册：NCT03545191（研究1）和NCT03575104（研究2）（ClinicalTrials.gov）

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来源期刊

Future Neurology CLINICAL NEUROLOGY-

CiteScore

2.10

自引率

0.00%

发文量

期刊介绍： The neurological landscape is changing rapidly. From the technological perspective, advanced molecular approaches and imaging modalities have greatly increased our understanding of neurological disease, with enhanced prospects for effective treatments in common but very serious disorders such as stroke, epilepsy, multiple sclerosis and Parkinson’s disease. Nevertheless, at the same time, the healthcare community is increasingly challenged by the rise in neurodegenerative diseases consequent upon demographic changes in developed countries.