莱博雷生(lemborexant)有哪些注意事项？

Considerations for (lemborexant, Dayvigo) include CNS depressant effects and daytime impairment, sleep paralysis, hypnotic/hypnotic hallucinations and cataplexy-like symptoms, complex sleep behavior, patients with compromised respiratory function, worsening of depression/suicidal ideation, and the need for evaluation of comorbid diagnoses.

About lemborexant

In December 2019, the U.S. Food and Drug Administration (FDA) approved the marketing of Eisai’s Dayvigo for the treatment of insomnia in adults. The active ingredient of Dayvigo, lemborexant, is a dual orexin receptor antagonist. Lemborexant inhibits orexin neurotransmission by competitively binding to the orexin-1 receptor (OX1R) and the orexin-2 receptor (OX2R) to regulate sleep-wake rhythms.

The following are lemborexant:

CNS depressant effects and daytime impairment

DAYVIGO is a central nervous system (CNS) depressant that may impair daytime arousal, even when used as prescribed. CNS depression may persist for several days after discontinuation of DAYVIGO in some patients. Prescribers should inform patients of the possibility of next-day drowsiness.

Some subjects taking 10 mg of this product had impaired driving ability. Taking this product with less than a full night's sleep remaining or taking a higher than recommended dose may increase the risk of daytime impairment. If this product is administered under these circumstances, patients should be cautioned against driving and other activities requiring full mental alertness.

Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which may result in daytime impairment. Due to potential additive effects, dosage adjustments of DAYVIGO and concomitant CNS depressants may be necessary when administered concurrently. It is not recommended to use this product in combination with other drugs to treat insomnia. Due to additive effects, patients should be advised not to drink alcohol and take this product at the same time.

Because DAYVIGO can cause drowsiness, patients, especially older adults, are at higher risk of falls.

Sleep paralysis, hypnotic/hypnotic hallucinations, and cataplexy-like symptoms

Use of this product may cause sleep paralysis, the inability to move or speak for several minutes during the sleep-wake transition, and hypnotic/hypnotic hallucinations, including vivid and disturbing sensations. Prescribers should explain the nature of these events to patients when prescribing DAYVIGO.

Using this product may cause symptoms similar to mild cataplexy. Such symptoms may include periods of leg weakness that last from seconds to minutes, may occur at night or during the day, and may not be associated with an identified triggering event (e.g., laughter or surprise).

Complex sleep behaviors

Complex sleep behaviors, including sleepwalking, sleepwalking while driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, talking on the phone, having sex), have been reported after use of sleeping pills (such as DAYVIGO). These events can occur in both hypnotic-naïve and hypnotic-experienced people. Patients often do not remember these events.

Complex sleep behaviors may occur after the first or any subsequent use of this product, with or without the concomitant use of alcohol and other CNS depressants.

If patients develop complex sleep behaviors, DAYVIGO should be discontinued immediately.

Patients with impaired respiratory function

If prescribed to patients with impaired respiratory function, the effects of DAYVIGO on respiratory function should be considered. This product has not been studied in patients with moderate to severe obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD).

Worst depression/suicidal ideation

In clinical studies of DAYVIGO in patients with insomnia, the incidence of suicidal thoughts or any suicidal behavior (as assessed by a questionnaire) was higher in the DAYVIGO group than in the placebo group (0.3% in the DAYVIGO 10 mg group, 0.4% in the DAYVIGO 5 mg group, and 0.2% in the placebo group).

Exacerbations of depression and suicidal thoughts and behaviors (including death by suicide) have been reported in patients with primary depression treated with hypnotics. Such patients may be suicidal and may require protective measures. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets feasible should be prescribed at all times.

The development of any new behavioral signs or symptoms of concern requires careful and immediate evaluation.

Need to evaluate comorbid diagnoses

Because sleep disturbances may be manifestations of medical and/or psychiatric disorders, treatment of insomnia should be initiated only after careful evaluation of the patient. Failure to resolve insomnia after 7-10 days of treatment may indicate the presence of a primary psychiatric and/or medical disorder that should be evaluated. Worsening of insomnia or the development of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or medical condition that may occur during treatment with sleep-promoting medications (such as DAYVIGO).

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