Onge Erin St, Phillips Bradley, Rowe Casey
Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, FL, USA.
J Pharm Technol. 2022 Oct;38(5):297-303. doi: 10.1177/87551225221112546. Epub 2022 Jul 26.
To review the safety, efficacy, and tolerability of daridorexant in treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients. A literature search was performed through PubMed using the following key terms: , and . Selected articles included those which described clinical studies of the pharmacokinetics, efficacy, safety, or tolerability of daridorexant. Daridorexant works through antagonism of the dual orexin receptor. It is the third agent in this class of medications approved by the U.S. Food and Drug Administration (FDA). Daridorexant, at a dose of 25 mg to 50 mg, was shown to be effective in improving sleep parameters in phase 3 clinical studies and was well tolerated. Adverse event rates from phase 2 and 3 clinical trials were low with fatigue, nasopharyngitis, gait disturbance, somnolence, diarrhea, and headache most commonly reported. All currently available agents for treating insomnia have received a "weak" recommendation in the clinical practice guidelines, including the dual orexin receptor antagonist class of medications. Initial data suggest that with routine use daridorexant does not impair next day functioning, a common issue with other agents used to treat insomnia. In addition, daridorexant appears to be as safe and effective in treating insomnia in patients of all ages including those ≥65 years of age.
评估达利雷生治疗成年患者中以入睡困难和/或睡眠维持困难为特征的失眠的安全性、有效性和耐受性。通过PubMed进行文献检索，使用以下关键词： ，以及 。入选的文章包括那些描述达利雷生药代动力学、有效性、安全性或耐受性的临床研究。达利雷生通过拮抗双重食欲素受体发挥作用。它是美国食品药品监督管理局（FDA）批准的这类药物中的第三种药物。在3期临床研究中，25毫克至50毫克剂量的达利雷生被证明能有效改善睡眠参数，且耐受性良好。2期和3期临床试验的不良事件发生率较低，最常报告的是疲劳、鼻咽炎、步态障碍、嗜睡、腹泻和头痛。在临床实践指南中，所有目前可用的治疗失眠的药物，包括双重食欲素受体拮抗剂类药物，都得到了“弱”推荐。初步数据表明，常规使用达利雷生不会损害次日功能，而这是用于治疗失眠的其他药物常见的问题。此外，达利雷生在治疗包括≥65岁患者在内的所有年龄段患者的失眠方面似乎同样安全有效。
