Clinical efficacy and effectiveness evaluation of DaliRasheng (Keweike) in the treatment of insomnia disorder

Daridorexant is a new dual-receptor (OX1R/OX2R) antagonist that regulates the sleep- wake cycle by blocking the action of hypnotic receptors, thereby improving insomnia symptoms such as difficulty falling asleep and nighttime awakening. Unlike traditional benzodiazepine hypnotics, dalirasin does not directly act on GABA receptors, so it has a lower risk of addiction and dependence, while showing advantages in maintaining nighttime sleep quality.

In multiple randomized, double-blind, placebo-controlled clinical trials, DaliRasen has shown significant efficacy in patients with moderate to severe insomnia disorder. Experimental data show that the patient's sleep latency (Sleep Onset Latency, SOL) is shortened by about 20–25 minutes on average, and the nighttime awakening time (Wake After Sleep Onset, WASO) decreased by approximately 35–45 minutes, while total sleep time (Total Sleep Time, TST) increased by approximately 60 minutes. The efficacy remained stable during evaluations of 4 weeks and 12 weeks of continuous use, demonstrating the ability to continuously improve sleep.

Patients' subjective evaluation showed that DaliRasen not only improved the speed of falling asleep, but also significantly reduced the frequency of nighttime awakenings and improved the wakefulness and mental state the next day. Compared with placebo, the drug group showed significant improvements in daytime functioning scores, fatigue, and mood improvements. In addition, the drug is well tolerated, with common adverse reactions including mild headache, drowsiness or dry mouth, most of which are short-lived and controllable, and the incidence of serious adverse events is low.

Clinically, DaliRasen is suitable for adult patients with moderate to severe insomnia disorder, especially those with poor tolerance to traditional benzodiazepines or who are at risk of dependence. During use, the dosage regimen should be formulated based on the patient's sleeping habits and individual response, and the improvement in sleep quality and daytime function should be regularly evaluated. Through continuous monitoring and individualized adjustments, DaliRasen can provide insomnia patients with a safe, effective and lasting sleep improvement solution.

Reference materials:https://www.drugs.com/