HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciLemb safely and effectively. See full prescribing information for LuciLemb.

INDICATIONS AND USAGE

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 ADMINISTRATION

• Recommended dose 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. Dosage may be increased to 10 mg based on clinical response and tolerability.

• The maximum recommended dose is 10 mg once daily.

• Time to sleep onset may be delayed if taken with or soon after a meal.

• Hepatic Impairment:

o Moderate hepatic impairment: Initial and maximum recommended dosage is 5 mg no more than once per night.

o Severe hepatic impairment: Not recommended.

DOSAGE FORMS AND STRENGTHS

Tablets: 5 mg×30 tablets

CONTRAINDICATIONS

LuciLemb is contraindicated in patients with narcolepsy.

WARNINGS AND PRECAUTIONS

• CNS Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases with dose and use with other central nervous system (CNS) depressants. For patients taking LuciLemb 10 mg, caution against next-day driving and other activities requiring complete mental alertness.

• Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of LuciLemb.

• Complex Sleep Behaviors: Behaviors including sleep-walking, sleepdriving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs.

• Compromised Respiratory Function: Effect on respiratory function should be considered.

• Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Prescribe the lowest number of tablets feasible to avoid intentional overdosage.

• Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment.

ADVERSE REACTIONS

The most common adverse reaction (reported in ≥5% of patients treated with LuciLemb and at least twice the rate of placebo) was somnolence.

DRUG INTERACTIONS

• Strong or moderate CYP3A inhibitors: Avoid concomitant use.

• Weak CYP3A inhibitors: The maximum recommended dose is 5 mg.

• Strong or moderate CYP3A inducers: Avoid concomitant use.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.