莱博雷生(lemborexant)在国内上市了吗?

lemborexant is a new insomnia treatment drug developed by Japan's Eisai Company and has been launched in China.

Lemborexant’s domestic listing situation

It has been launched in the country. On May 27, 2025, Eisai announced that its marketing application for Lebrasin Tablets has been approved by the National Medical Products Administration (NMPA) of China. Patients can directly purchase the drug through regular domestic hospital or pharmacy channels.

Correct usage of lemborexant

1. Routine dosage and administration

(1). Starting dose: The recommended starting dose is 5mg, once per night, and no more than once per night.

(2). Taking time: It should be taken at least 7 hours before planned waking time and immediately before going to bed.

(3) Dose adjustment: The dose can be increased to the maximum recommended dose of 10 mg based on clinical response and tolerance.

(4) Precautions: If taken with a meal or shortly after a meal, it may delay the time to fall asleep. It is recommended to take it on an empty stomach before going to bed.

2. Dose adjustment for special groups and concomitant medications

(1) Patients with liver dysfunction: The maximum recommended dose for patients with moderate liver damage is 5 mg; use is not recommended for patients with severe liver damage.

(2) Patients with renal insufficiency: Patients with mild, moderate and severe renal impairment usually do not need to adjust the dose, but patients with severe renal impairment may have an increased risk of drowsiness.

3. Interaction with CYP3A inhibitors/inducers

(1) Avoid combined use: Avoid concurrent use with strong or moderate CYP3A inhibitors (such as ketoconazole, clarithromycin) or inducers (such as rifampicin, carbamazepine).

(2) Weak inhibitor: If used in combination with a weak CYP3A inhibitor, the maximum dose shall not exceed 5 mg.

Adverse reactions and precautions of lemborexant

1. Common adverse reactions

The most common adverse reaction is drowsiness, which occurs in ≥5% of treated patients and is at least twice the incidence in the placebo group.

2. Important precautions

(1) Central nervous system depressant effect: Medication may cause daytime drowsiness, decreased energy, slowed thinking and movement ability, and affect the ability to drive or operate machinery. Avoid these (1) hazardous activities until you fully understand how this medicine affects you.

(2) Abnormal sleep behavior: sleep paralysis, hypnotic hallucinations (vivid perceptions while half dreaming and half awake), and complex sleep behaviors (such as getting out of bed, driving, eating, or making phone calls when not fully awake, and being unable to recall them afterwards) may occur. If such behavior occurs, seek medical attention immediately.

(3) Risk of falls: Drowsiness and drowsiness caused by drugs will increase the risk of falls. Elderly patients aged 65 and above need to be particularly vigilant. It is recommended that the elderly should be cautious when using doses greater than 5 mg.

3. Other safety tips

(1) Respiratory function: For patients with impaired respiratory function such as obstructive sleep apnea or chronic obstructive pulmonary disease, the possible respiratory effects of Lebraxen cannot be ruled out and must be used under close supervision by a doctor.

(2) Discontinuation of medication and medical treatment: Pay close attention to body reactions during medication. If severe discomfort or the above abnormal symptoms occur, stop use immediately and consult a doctor. Also, avoid drinking alcohol while taking this medication.