Why can't lemborexant completely cure insomnia?

Lemborexant can help relieve insomnia symptoms, but it cannot completely cure insomnia. Insomnia is a complex sleep disorder whose causes may involve lifestyle, environmental, psychological and physiological factors.

Medication is only one part of insomnia management and should usually be used in conjunction with other non-drug treatments. As a sleep aid, leborexan can help reduce the time it takes to fall asleep, increase sleep time, and improve sleep quality.

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Leborexan is an orally administered dual orexin receptor (OXR) antagonist that exhibits reversible competitive antagonism (affinity for OXR2) on OXR1 and OXR2, discovered and developed by Eisai Inc. for the treatment of adult patients with insomnia.

In December 2019, Lebrasen was first approved (final interim arrangement) in the United States for the treatment of adult patients with insomnia, characterized by difficulty in sleep initiation and/or sleep maintenance.

In January 2020, Lebrasin was also approved in Japan for the treatment of insomnia.

The mechanism of action for treating insomnia is by antagonizing orexin receptors, which can produce sedative and hypnotic effects, thereby helping patients fall asleep and stay asleep. For some patients with insomnia caused by mental stress, anxiety, fear, etc., Lebraxen may be helpful. However, Leborexan does not treat the underlying cause of insomnia, so it cannot completely cure insomnia.

Leborexan cannot completely cure the cause of insomnia

1. The causes of insomnia are complex: Insomnia may be caused by many reasons, including environment, individual factors, physical factors, mental factors, emotional factors, etc. Leborexan mainly improves insomnia symptoms by regulating sleep neurotransmitters, but it may not have a curative effect on other causes of insomnia.

2. Diversity of insomnia symptoms: Insomnia symptoms include difficulty falling asleep, waking up easily, waking up early, poor sleep quality, etc. Different insomnia symptoms require different treatment methods. Leborexan mainly targets two symptoms: difficulty falling asleep and maintaining sleep. It may not provide adequate treatment for other types of insomnia symptoms.

3. Individual differences: Different individuals may have different reactions to Leborex, and some people may be insensitive to the effects of the drug and may even experience side effects. Therefore, in practical applications, leborexan may not be able to completely cure insomnia in all patients.

4. Limitations of the treatment plan: Leborexen is a single drug, and the treatment of insomnia requires comprehensive consideration of the patient's cause, symptoms, physical condition and other factors to formulate a personalized treatment plan. Therefore, relying only on Leborexan alone cannot completely solve all insomnia problems.

Clinical clinical use of leborexan in the treatment of insomnia

Purpose of the study: To compare the efficacy of the orexin receptor antagonist leborexan with placebo and zolpidem tartrate extended-release in the treatment of insomnia.

Research methods: In a global randomized double-blind parallel group placebo-controlled active-controlled phase 3 study, 1006 eligible insomnia patients received placebo (=208), zolpidem tartrate extended-release (n =263), or leborexan 5mg (n=266) or 10mg (n=269) before going to bed for 1 month.

MAIN RESULTS: The primary endpoint was the change in latency from baseline to sustained sleep with leborexan treatment compared with placebo. Key secondary endpoints were changes from baseline in sleep efficiency and post-sleep arousal episodes compared with placebo, and post-sleep arousal episodes in the second half of the night compared with zolpidem treatment.

Study Results: Compared to placebo, both doses of leborexan treatment demonstrated statistically significant greater changes from baseline to objective sleep onset, as assessed by latency to sustained sleep (log-transformed), as measured using polysomnography at the end of 1 month of treatment.

Mean change from baseline in sleep efficiency as measured by polysomnography on nights 29 and 30 (LSM treatment difference compared with placebo 5 mg of leborexen, 7.1%; 95% CI, 5.6%-8.5%; P < .001, and 10 mg leborexen 8.0%; 95% CI, 6.6%-9.5%; P < .001).

The onset of post-sleep awakening was -24.0 minutes for placebo and -25.4 minutes for 10 mg leborexine. Treatment efficacy with both doses of leborexan was significantly higher compared with placebo.

Study Conclusions: In this randomized clinical trial, leborexan treatment significantly improved sleep onset and sleep maintenance, including in the second half of the night, compared with placebo and zolpidem, as measured objectively using polysomnography, and was well tolerated.

Summary

Although leborexan can improve the symptoms of insomnia, it cannot completely cure insomnia. For patients with long-term or severe insomnia, they should seek medical treatment promptly and seek help from professional doctors for diagnosis and treatment.

A more comprehensive approach to treating insomnia may include improving the sleep environment, establishing healthy sleep habits, avoiding stimulating substances (such as caffeine and alcohol), relaxation techniques, and cognitive behavioral therapy. When it comes to treating insomnia, individual situations vary greatly, so it’s recommended to consult with a medical professional or sleep specialist to develop a personalized treatment plan based on your specific situation.

References:

Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254. Erratum in: JAMA Netw Open. 2020 Apr 1;3(4):e206497. 31880796; PMCID: PMC6991236.

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