Dayvigo (Lemborexant Tablets) – NREM/REM | HongKong DengYue Medicine

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.

Guidelines for the Use of Lemborexant Tablets

• 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

Lemborexant Tablets Interactions

• 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.