2024 Latest News on Labrexant: Is it safe for long-term use?

June 17, 2025

😴At a time when insomnia is becoming more and more common, finding a safe and effective treatment has become an urgent need for many patients. As a new insomnia treatment drug, Lebrexan has attracted much attention since its launch. Especially in terms of long-term safety, it is the focus of everyone's concern. So, what is the latest development about Lebrexan in 2024? Is it safe for long-term use? Today, let's take a look.

The mechanism of action of Lebrexan

🛠️Lebrexan is a dual orexin receptor antagonist. Simply put, orexin is a neuropeptide that promotes wakefulness produced by the lateral hypothalamus. It needs to bind to orexin 1 and 2 receptors to control the sleep-wake state. If orexin is secreted too much at night, the wakefulness system will be too strong, making it impossible to switch smoothly to the sleep system, which will cause insomnia. Lebrexan inhibits the wakefulness-promoting effect of orexin by blocking the binding of orexin to these two receptors, just like pressing the off button on the brain's wakefulness switch, thereby inducing physiological sleep, helping patients to naturally enter a sleep state, and maintain good sleep quality. This unique mechanism of action intervenes in insomnia at the root, which is fundamentally different from traditional sleeping pills.

Long-term safety data

No addiction and withdrawal reaction🔒

🏥Clinical studies have shown that Lebrexan has significant advantages in long-term use. Unlike traditional benzodiazepines (such as diazepam) or non-benzodiazepines (such as zolpidem), these traditional drugs widely inhibit central nervous system activity, which is not only prone to cognitive and psychiatric side effects, such as memory impairment, cognitive deficits, sleepwalking and other complex sleep behaviors, but also addictive. Withdrawal symptoms may occur after long-term use. Lebrexan performs well in this regard, and the US Drug Enforcement Administration has classified it as an IV drug, which means it has a low risk of abuse. In a 12-month global multicenter study, most patients stopped taking Lebrexan after long-term use, and no withdrawal symptoms or rebound insomnia were observed, which brought hope to patients who have long suffered from insomnia and worried about drug addiction.

The side effects are mild and well tolerated🛡️

💊During the treatment process of more than 12 months, the common adverse reactions of subjects using Lebrexan were mostly mild to moderate. Common ones include nasopharyngitis, headache, and drowsiness. Compared with traditional drugs, no significant cognitive impairment or complex sleep behavior was reported. In terms of daytime residual effects, the effects on driving skills and body balance 8-9 hours after administration were no different from placebo, greatly reducing the impact of next-day sleepiness on daily life and work. Moreover, because its mechanism of action does not disrupt the body's original sleep structure, while increasing REM (rapid eye movement) and non-REM sleep, it will not produce side effects such as dizziness and headache, reflecting good tolerability.

Long-term effectiveness and stability📈

📊The same 12-month global multicenter study also showed that the efficacy of Lebrexan can last for at least one year without drug resistance. This means that patients do not have to worry about the gradual weakening of the drug effect over time during long-term use. For example, in clinical trials, after patients took Lebrexan for 6 consecutive months, their subjective sleep latency (sSOL) was shortened by nearly 50%, and their sleep efficiency (sSEF) was increased to more than 75% (baseline about 63%), and this sleep improvement effect was able to be maintained stably during the 12-month observation period.

Applicable people and usage suggestions

👥Lebrexan is suitable for adult insomnia patients characterized by difficulty falling asleep and/or maintaining sleep. The general standard starting dose is 5 mg, taken once a night before bedtime, and should be taken at least 7 hours before the planned awakening time to avoid residual effects the next morning. The doctor will gradually increase the dose to the maximum recommended dose of 10 mg based on the patient's clinical response and tolerance. However, although Lebrexan is relatively safe, there are some precautions when using it. For example, avoid drinking alcohol🍷, because alcohol may affect the effectiveness of drug treatment; patients with depression should use it with caution😟, and there have been reports of worsening depression or suicidal thoughts during treatment; be alert to possible complex sleep behaviors, such as sleepwalking, sleep driving, etc. If they occur, they should be discontinued and medical staff should be notified immediately🚑; after using the drug, if the remaining sleep time is less than a full night, or exceeds the recommended dose, it will increase the risk of daytime injury, and driving or engaging in activities that require high vigilance should be avoided at this time🚗.

🔚Based on the latest information in 2024, Lebrexan has excellent safety in long-term use, providing a safer and more physiological treatment option for insomnia patients. Its unique mechanism of action brings advantages such as low addiction, mild side effects, and good long-term effectiveness and stability. If you are suffering from insomnia, you may want to consider Lebrexan.