DAYVIGO Film-coated tablet Ref.[10116] Active ingredients:

2.1 Dosing Information

The recommended dosage of DAYVIGO 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. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal [see Clinical Pharmacology (12.3)].

2.2 Dosage Recommendations for Concomitant Use with CYP3A Inhibitors or CYP3A Inducers

Co-administration with Strong or Moderate CYP3A Inhibitors

Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Co-administration with Weak CYP3A Inhibitors

The maximum recommended dosage of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Co-administration with Strong or Moderate CYP3A Inducers

Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

2.3 Dosage Recommendations for Patients with Hepatic Impairment

The maximum recommended dose of DAYVIGO is 5 mg no more than once per night in patients with moderate hepatic impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

DAYVIGO is not recommended in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

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.

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].