DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. (1)

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. (2.1)
• The maximum recommended dose is 10 mg once daily. (2.1)
• Time to sleep onset may be delayed if taken with or soon after a meal. (2.1)
• Hepatic Impairment: (2.3)
• Moderate hepatic impairment: Initial and maximum recommended dosage is 5 mg no more than once per night.
• Severe hepatic impairment: Not recommended.

——————— DOSAGE FORMS AND STRENGTHS ——————–­

Tablets: 5 mg, 10 mg (3)

The most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 18882742378 or FDA at 1800FDA1088 or www.fda.gov/medwatch.

DAYVIGO is contraindicated in patients with narcolepsy. (4)

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 DAYVIGO 10 mg, caution against nextday driving and other activities requiring complete mental alertness. (5.1)
• Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy like Symptoms: May occur with use of DAYVIGO. (5.2)
• Complex Sleep Behaviors: Behaviors including sleepwalking, sleepdriving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs. (5.3)
• Compromised Respiratory Function: Effect on respiratory function should be considered. (5.4, 8.8) Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Prescribe the lowest number of tablets feasible to avoid intentional overdosage. (5.5)
• Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. (5.6)

• Strong or moderate CYP3A inhibitors: Avoid concomitant use. (7.1)
• Weak CYP3A inhibitors: The maximum recommended dose is 5 mg. (2.2, 7.1)
• Strong or moderate CYP3A inducers: Avoid concomitant use. (7.1)

There is limited clinical experience with DAYVIGO overdose. In clinical pharmacology studies, healthy patients who were administered multiple doses of up to 75 mg (7.5 times the maximum recommended dose) of DAYVIGO showed dose-dependent increases in the frequency of somnolence.

There is no available specific antidote to an overdose of DAYVIGO. In the event of overdose, standard medical practice for the management of any overdose should be used. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. Consult a Certified Poison Control Center for the most up to date information on the management of overdosage (1-800-222-1222 or www.poison.org).

The value of dialysis in the treatment of overdosage has not been determined with lemborexant. As lemborexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of lemborexant.