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)].