Lemborexant Tablets Application Scope

Lemborexant is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Lemborexant Tablets Characteristics

Ingredients: Lemborexant (active ingredient).
Properties: White to off-white crystalline powder; soluble in organic solvents.
Packaging Specification: Film-coated tablets, commonly available in 5 mg and 10 mg strengths.
Storage: Store at room temperature (20–25 °C). Protect from moisture and light.
Expiry Date: As indicated on the packaging.
Executive Standard: In accordance with pharmacopoeial and regulatory drug quality standards.
Approval Number: As indicated on the packaging.
Date of Revision: As indicated on the packaging.
Manufacturer: Eisai China Inc.

Dosage and Administration: Oral administration before bedtime.
- Recommended Dose:
  - Starting dose: 5 mg once nightly, immediately before bedtime.
  - May be increased to 10 mg based on clinical response and tolerability.
  - Do not exceed 10 mg once daily.
- Administration:
  - Take orally, immediately before going to bed, with at least 7 hours remaining before planned awakening.
  - May be taken with or without food.
- Missed Dose: If a dose is missed, skip the missed dose and take the next dose at the scheduled time. Do not double the dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Somnolence or drowsiness
  - Fatigue
  - Headache
  - Nightmares or abnormal dreams
- Serious Adverse Reactions:
  - Complex sleep behaviors (e.g., sleepwalking, sleep driving, engaging in activities while not fully awake)
  - Worsening of depression or suicidal ideation
  - Respiratory depression in patients with compromised respiratory function
Contraindications:
- Known hypersensitivity to lemborexant or any component of the formulation
- Concomitant use with strong CYP3A inhibitors
- Patients with narcolepsy
Precautions:
- Use caution in elderly patients due to risk of falls and cognitive impairment
- Use caution in patients with depression, respiratory disorders, or hepatic impairment
- Avoid alcohol and CNS depressants
- May impair next-day driving and activities requiring alertness

Strong CYP3A inhibitors (e.g., itraconazole, clarithromycin): Contraindicated due to increased lemborexant exposure.
Moderate CYP3A inhibitors (e.g., diltiazem, verapamil): Dose adjustment may be required.
Strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort): May reduce efficacy of lemborexant.
Additive CNS depressant effects with alcohol, opioids, benzodiazepines, or other sedatives.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.