Drug safety analysis and long-term use risk assessment of DaliRasheng (Keweike)

Daridorexant is a dual orexin receptor antagonist (DORA), which mainly inhibits orexin A and B receptor (OX1R, OX2R) activity, thus improving the difficulty in falling asleep and maintaining sleep in insomnia patients. Unlike traditional benzodiazepine sedatives, Dalitrazolin does not work by enhancing GABA activity, so it shows higher safety in terms of sedation, dependence, cognitive impairment, etc. Clinical studies have shown that DaliRasen is well tolerated in the dose range of 25 mg to 50 mg. The main adverse reactions are mild to moderate, and most of them can be relieved without stopping the drug. The overall safety is better than traditional sleeping pills, and it is suitable for patients with long-term chronic insomnia.

In two three-monthPhase III clinical trials, the safety data of DaliRazen were stable. The most common adverse reactions include headache (about 6%), drowsiness (about 5%), fatigue (about 4%) and dizziness (about 3%). These side effects mostly occur in the early stages of treatment and diminish as the body adapts. Compared with the control group, dalirasin did not significantly increase the risk of nocturnal falls, cognitive impairment, or abnormal sleep behavior. It is worth noting that its elimination half-life is short (about 8 hours), which can reduce residual sleepiness the next day and has less impact on daytime work and driving safety. In addition, no obvious withdrawal reactions or rebound insomnia were observed after discontinuation of the drug, indicating that the risk of dependence is low.

In the 12-month long-term follow-up study, the safety profile of DaliRasen remained stable, with no obvious cumulative toxicity or organ damage. Experimental data showed that liver function, kidney function and hematological indicators did not show significant changes in people taking the drug for a long time. Its main metabolic pathway is the CYP3A4 enzyme system. Therefore, caution is required when using strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin) or inducers (such as rifampicin) in combination to prevent the drug's blood concentration from being too high or its efficacy reduced. During long-term medication, individual patients may experience a mild decrease in attention or an increase in dreams, but the overall risk is controllable. Compared with traditional hypnotics, Dalitrazolin did not exhibit significant tolerance enhancement or dose dependence.

Clinically, it is recommended that patients start with a low dose (25mg/Late), adjust the dose according to efficacy and tolerance. Elderly patients, those with impaired liver function, or those taking CYP3A4 inhibitory drugs should reduce the dose appropriately. For patients with chronic insomnia who require long-term medication, sleep quality and daytime function should be evaluated regularly to prevent the formation of psychological dependence. The safety of DaliRazen in long-term use has been verified by multi-center studies, but individual metabolic differences and potential drug interactions still need to be paid attention to. Overall, DaliRasen has both good sleep improvement effect and high safety margin, providing a new option for insomnia treatment, especially suitable for patients who have poor tolerance to traditional sleeping pills or are worried about the risk of dependence.

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