Lemborexant

LuciLemb (Lemborexant) 5mg

EACH LUCILEMB TABLET CONTAINS: Lemborexant ………………… 5 mg

INDICATION:

LuciLemb is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

DOSAGE AND USE:

• The recommended dosage is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening.
• Based on clinical response and tolerability, the dose may be increased to a maximum of 10 mg once daily.
• Maximum recommended dose: 10 mg once daily.
• Avoid taking with or soon after a meal, as it may delay the onset of effect.
• Tablets should be swallowed whole and not crushed or chewed.

CONTRAINDICATIONS:

• Patients with narcolepsy.

WARNINGS AND PRECAUTIONS:

• CNS depressant effects and daytime impairment: May impair alertness and motor coordination, including driving ability.
• Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms may occur.
• Complex sleep behaviors (e.g., sleep-walking, sleep-driving) have been reported; discontinue if these occur.
• Worsening of depression/suicidal ideation may occur.
• Use caution in patients with compromised respiratory function.
• Elderly patients may be at higher risk of falls due to somnolence.

ADVERSE REACTIONS:

Most common adverse reaction (≥5% and greater than placebo):

Somnolence (drowsiness)

Other reported reactions may include headache, fatigue, and abnormal dreams.

DRUG INTERACTIONS:

• Avoid concomitant use with strong or moderate CYP3A inhibitors.
• Avoid use with strong or moderate CYP3A inducers as it may reduce effectiveness.
• Concomitant use with other CNS depressants (e.g., benzodiazepines, alcohol) may increase risk of sedation.

USE IN SPECIAL POPULATIONS:

• Hepatic impairment: Dose adjustment may be required in moderate impairment; not recommended in severe impairment.
• Pregnancy & lactation: Use only if clearly needed; consult a physician.
• Pediatric use: Safety and effectiveness not established.
• Geriatric use: Increased sensitivity possible; use with caution.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Keep medicine out of the reach of children.

PACKAGING:

Available in packs of 30 tablets.

Manufactured and Marketed by:

LUCIUS PHARMACEUTICALS (LAO) CO., LTD

No. 26, Thongmang Village, Xaythany District, Vientiane Capital, Laos