Dayvigo Dosage/Direction for Use

Posology: 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 PHARMACOLOGY under Actions].
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 Interactions and PHARMACOLOGY under Actions].
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 Interactions and PHARMACOLOGY under Actions].
Co-administration with Strong or Moderate CYP3A Inducers: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Interactions and PHARMACOLOGY under Actions].
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 Hepatic Impairment as follows and PHARMACOLOGY under Actions].
DAYVIGO is not recommended in patients with severe hepatic impairment [see Hepatic Impairment as follows].
Pediatric Use: The safety and effectiveness of DAYVIGO have not been established in pediatric patients.
Geriatric Use: Of the total number of patients treated with DAYVIGO (n=1418) in controlled Phase 3 studies, 491 patients were 65 years and over, and 87 patients were 75 years and over. Overall, efficacy results for patients <65 years of age were similar compared to patients ≥65 years. 
In a pooled analysis of Study 1 (the first 30 days) and Study 2, the incidence of somnolence in patients ≥65 years with DAYVIGO 10 mg was higher (9.8%) compared to 7.7% in patients <65 years. The incidence of somnolence with DAYVIGO 5 mg was similar in patients ≥65 years (4.9%) and <65 years (5.1%). The incidence of somnolence in patients treated with placebo was 2% or less regardless of age [see PHARMACOLOGY: Pharmacodynamics: CLINICAL STUDIES under Actions]. Because DAYVIGO can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Precautions]. Exercise caution when using doses higher than 5 mg in patients ≥65 years old.
Renal Impairment: No dose adjustment is required in patients with mild, moderate, or severe renal impairment.
DAYVIGO exposure (AUC) was increased in patients with severe renal impairment. Patients with severe renal impairment may experience an increased risk of somnolence [see PHARMACOLOGY under Actions].
Hepatic Impairment: DAYVIGO has not been studied in patients with severe hepatic impairment. Use in this population is not recommended [see Dosage Recommendations for Patients with Hepatic Impairment as previously mentioned and PHARMACOLOGY under Actions].
DAYVIGO exposure (AUC and C_max) and terminal half-life were increased in patients with moderate hepatic impairment (Child-Pugh class B). Dosage adjustment is recommended in patients with moderate hepatic impairment (Child-Pugh class B) [see Dosage Recommendations for Patients with Hepatic Impairment as previously mentioned and PHARMACOLOGY under Actions].
DAYVIGO exposure (AUC) was increased in patients with mild hepatic impairment (Child-Pugh class A), but the terminal half-life was not changed. Patients with mild hepatic impairment may experience an increased risk of somnolence [see PHARMACOLOGY under Actions].
Patients with Compromised Respiratory Function: In a study of patients with mild OSA (apnea-hypopnea index <15 events per hour of sleep), DAYVIGO did not increase the frequency of apneic events or cause oxygen desaturation.
DAYVIGO has not been studied in patients with COPD or moderate to severe OSA. Clinically meaningful respiratory effects of DAYVIGO in COPD or moderate to severe OSA cannot be excluded [see Precautions].
Method of administration: For oral use.