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Posology: The recommended dose of lemborexant is 5 mg taken no more than once per night, and within a few minutes before going to bed, with at least 7 hours remaining before the planned time of awakening. If the 5 mg dose is well-tolerated but greater effect is needed, the dose can be increased to 10 mg once daily.
The maximum recommended dose of lemborexant is 10 mg once daily.
Time to sleep onset may be delayed if taken with or soon after a meal.
Patients should be advised not to consume alcohol in combination with lemborexant.
Use with CYP3A Inhibitors: Co-administration with Moderate or Strong CYP3A Inhibitors: Avoid concomitant use of lemborexant 5 or 10 mg with moderate or strong CYP3A inhibitors.
Co-administration with Weak CYP3A Inhibitors: The maximum recommended dose of lemborexant is 5 mg when co-administered with weak CYP3A inhibitors.
Use with CYP3A Inducers: Co-administration with Moderate or Strong CYP3A Inducers: Avoid concomitant use of lemborexant with moderate or strong CYP3A inducers.
Special Populations: Renal Impairment: No dose adjustment is required in patients with mild, moderate, or severe renal impairment.
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. The maximum recommended dose of lemborexant is 5 mg in patients with moderate hepatic impairment. Lemborexant is not recommended in patients with severe hepatic impairment.
Geriatric Patients: There were no clinically meaningful differences in safety or effectiveness observed between elderly patients (≥65 years) and adult patients at the recommended doses. No dose adjustment is required in geriatric patients.
Of the total number of patients treated with lemborexant (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 303 (the first 30 days) and Study 304, the incidence of somnolence in patients ≥65 years with lemborexant 10 mg was higher (9.8%) compared to 7.7% in patients <65 years. The incidence of somnolence with lemborexant 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.
Pediatric Patients: The safety and effectiveness of lemborexant have not been established in pediatric patients (below 18 years of age). Lemborexant is not recommended in pediatric patients.
Compromised Respiratory Function: Obstructive Sleep Apnea: In a study of patients with mild obstructive sleep apnea (apnea-hypopnea index <15 events per hour of sleep) lemborexant did not increase the frequency of apneic events or decrease mean peripheral capillary oxygen saturation. In a study of patients with moderate or severe obstructive sleep apnea (apnea-hypopnea index ≥15 events per hour of sleep), overall, lemborexant did not increase the frequency of apneic events or decrease mean peripheral capillary oxygen saturation.
Chronic Obstructive Pulmonary Disease: In a study of patients with moderate or severe chronic obstructive pulmonary disease (COPD), overall, lemborexant did not increase the frequency of apneic events or decrease mean peripheral capillary oxygen saturation.
Method of Administration: For oral use only.
