What are the precautions for taking lemborexant?

In clinical studies of lemborexant in the treatment of insomnia, warnings and precautions such as central nervous system depression and daytime impairment, sleep paralysis, hypnotic/hypnotic hallucinations and cataplexy-like symptoms, complex sleep behavior, patients with impaired respiratory function, exacerbation of depression/suicidal ideation, etc. have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Central nervous system depression and daytime damage

Leborexan can cause significant central nervous system depression. Even if taken at the prescribed dose, drowsiness and decreased concentration may occur the next day, which may affect driving and work performance in severe cases. Studies have shown that some subjects who took 10 mg had impaired driving ability the next day, especially when they did not get a full night's sleep, the dose exceeded the standard, or they were combined with other CNS depressants. The risk of falls caused by drowsiness after use by the elderly also needs to be taken into consideration.

In addition, Leborexan is not recommended to be used in combination with benzodiazepines, opioids, tricyclic antidepressants, alcohol, etc. CNS depressant drugs to avoid superimposed inhibitory effects and cause more serious adverse reactions. Patients should avoid drinking alcohol and drive carefully or engage in activities that require high alertness while using.

2. Sleep paralysis, hallucinations and cataplexy-like symptoms

Some patients may experience sleep paralysis during use, which is a brief inability to move or speak when waking or falling asleep, which can last for several minutes. They may also experience vivid and disturbing hypnotic hallucinations. These symptoms, although usually short-lived, may cause psychological discomfort. There are also some patients who experience a situation similar to cataplexy, that is, sudden leg weakness that lasts from seconds to minutes and can occur without trigger during the day or night.

3. Complex sleep behavior

Leborexen can induce "complex sleep behaviors," including sleepwalking, preparing or eating food, driving, talking on the phone, and even having sex while not fully awake. Patients often have no memory of these behaviors, and in severe cases, there are safety risks. It may occur even if it is used for the first time or if it is not combined with alcohol, so if such behavior occurs, the drug must be stopped immediately and professional evaluation must be carried out.

4. Risks for patients with impaired respiratory function

In short-term studies, leborexan has been used in patients with mild to severe obstructive sleep apnea (OSA) and moderate to severe chronic obstructive pulmonary disease (COPD), but caution should be used. Especially people with impaired respiratory function should be evaluated for possible adverse effects after taking the drug.

5. Worsening of depression and suicidal ideation

Studies have shown that the incidence of suicidal ideation or behavior in patients taking leborexan was slightly higher than that in the placebo group (e.g.0.3% in the 10 mg group, compared with 0.2% in the placebo group). Therefore, depressed patients need to closely monitor mood changes during use. There are also clinical reports of sleeping pills inducing or exacerbating the risk of depression and suicide, especially in patients with primary depression. Therefore, the psychological status of such patients should be assessed and necessary protective measures should be taken, such as limiting the number of prescriptions and avoiding overdose.

6. Assessment of comorbid conditions

Insomnia is often a symptom of other mental or physical illnesses rather than an independent disease. Therefore, the patient's overall health needs to be fully assessed before starting treatment. If symptoms do not improve after 7–10 days of treatment, it may indicate an unrecognized underlying cause, such as anxiety, depression, or thyroid dysfunction. At this time, the drug should be suspended and the direction of treatment should be re-evaluated.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd