Clinical efficacy and evaluation of the treatment of insomnia with DaliRasheng (Keweike)

Daridorexant (Daridorexant) is a new mechanism of insomnia treatment drug. It belongs to the dual orexin receptor antagonist (DORA) class. It selectively blocks orexin receptors1 and receptors 2 (OX1R, OX2R), thereby inhibiting arousal signals and helping patients fall asleep naturally and maintain sleep. This is completely different from the mechanism by which traditional benzodiazepines or Z-type drugs (such as zolpidem) inhibit neural activity by enhancing the GABAergic system, so they have shown better efficacy and safety in clinical applications. With the gradual promotion of DaliRasen in the European and American markets, its application effects and clinical data in patients with insomnia have also attracted more and more attention.

From the perspective of clinical trials, the efficacy of DaliRasen has been confirmed by a number of large-scale randomized, double-blind, placebo-controlled studies. The most representative ones are two key Phase III clinical trials, which included more than 1800 insomnia patients who met the DSM-5 diagnostic criteria. Subjects took 50 mg or 25 mg of dalilasen before going to bed every day for 3 months. The results showed that compared with the placebo group, the sleep onset latency period of the dalirasin group was significantly shortened and the speed of falling asleep was significantly increased, and stable improvement could be maintained at the 1st and 3rd months. In addition, the patient's total sleep time was significantly longer, the number of nighttime awakenings was reduced, and the consistency of sleep was improved. This shows that DaliRasen not only has a clear advantage in the speed of onset of action, but also can maintain its efficacy during long-term treatment.

More importantly, DaliRasen has relatively little impact on next-day residual effects. Among similar drugs, some hypnotics often cause adverse reactions such as drowsiness, inattention, and slow reaction the next day. However, DaliRasen has shown good tolerance in clinical trials. The study found that while 50 mg dose of dalirasin improved nighttime sleep, it did not significantly affect alertness and cognitive function the next morning. This is particularly important for insomnia patients who need to work, drive, or engage in activities that require concentration during the day. At the same time, DaliRazen is not prone to producing dependence and withdrawal symptoms. After long-term use, the patient's sleep quality will not rebound significantly, which reflects the drug's stability advantage in the treatment of chronic insomnia.

Judging from patient feedback, DaliRasen can improve symptoms of difficulty falling asleep and multiple awakenings at night, improve overall sleep quality, and further improve daytime functional performance, including attention, emotional state, work efficiency, etc. Some patients report that after taking the medicine for a few days to a week, they can obviously feel that they fall asleep faster at night, wake up less at night, and their mental state improves when they wake up in the morning. Compared with traditional sleeping pills, the side effects of DaliRazen are relatively mild. Common adverse reactions include mild headache, fatigue or mild nausea, most of which are short-lived and can be relieved by themselves.

Taken together, Daridorexant (Daridorexant), as a new insomnia treatment drug, has the dual effects of significantly improving falling asleep and maintaining sleep. Its clinical efficacy has been fully confirmed in a number of large international clinical trials. Compared with traditional hypnotics, it not only has sustained and stable efficacy, but also has good safety, low risk of dependence, and mild residual effects the next day. Therefore, it has important application prospects in the long-term treatment of chronic insomnia. With the launch of the drug in more countries and regions and the accumulation of real-world data, DaliRasen is expected to become a new option for the treatment of insomnia, providing better treatment options for patients who are refractory or have poor response to traditional drugs.

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