United States - English - NLM (National Library of Medicine)

eisai inc. - lemborexant (unii: 0k5743g68x) (lemborexant - unii:0k5743g68x) - dayvigo is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see clinical studies ( 14.1 )] . dayvigo is contraindicated in patients with narcolepsy. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to dayvigo during pregnancy. healthcare providers are encouraged to register patients in the dayvigo pregnancy registry, a part of the national pregnancy registry for psychiatric medications, at1-866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry. risk summary there are no available data on dayvigo use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of lemborexant to pregnant rats and rabbits during the period of organogenesis caused toxicities only at high multiples of the human exposure at the maximum recommended human dose (mrhd) based on auc. the no observed adverse effect levels (noael) are approximately >100 and 23 times the mrhd based on auc in rats and rabbits, respectively. similarly, oral administration of lemborexant to pregnant and lactating rats caused toxicities only at high multiples of the human exposure at the mrhd based on auc. the noael is 93 times the mrhd based on auc ( see data ) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data lemborexant was administered orally to pregnant rats during the period of organogenesis in 2 studies at doses of 60, 200, and 600 mg/kg/day or 20, 60, and 200 mg/kg/day, which are approximately 6 to >300 times the mrhd based on auc. lemborexant caused maternal toxicity, manifested by decreased body weight and food consumption, decreased mean fetal body weight, an increased number of dead fetuses, and skeletal, external and visceral malformations (omphalocele, cleft palate, and membranous ventricular septal defect) at >300 times the mrhd based on auc. the noael of 200 mg/kg/day is approximately 143 times the mrhd based on auc. lemborexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 10, 30, and 100 mg/kg/day, which are approximately 7 to 139 times the mrhd based on auc. lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and a higher incidence of skeletal variations (presence of cervical ribs and supernumerary lung lobes) at approximately 139 times the mrhd based on auc. the noael of 30 mg/kg/day is approximately 23 times the mrhd based on auc. lemborexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 100, and 300 mg/kg/day, which are approximately 15 to 206 times the mrhd based on auc. lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and toxicity to offspring consisting of decreased pup body weights, decreased femur length, and decreased acoustic startle responses at 206 times the mrhd based on auc. the noael of 100 mg/kg/day is approximately 93 times the mrhd based on auc. risk summary available data from a lactation study in 8 women indicates that lemborexant is transferred into the breastmilk of nursing mothers, and the results have established a mean daily infant dose of 0.0029 mg/kg/day and a relative infant dose of less than 2% of the maternal dose. these data support that transfer of lemborexant into breastmilk is low (see data). there are no data on the effects of lemborexant on the breastfed infant, or the effects on milk production. infants exposed to dayvigo through breastmilk should be monitored for excessive sedation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dayvigo and any potential adverse effects on the breastfed infant from dayvigo or from the underlying maternal condition. data a single dose milk-only lactation study was conducted in 8 healthy adult lactating women. the mean amount of lemborexant recovered in human milk was 0.0174 mg following a 10 mg maternal dose. the mean calculated daily infant oral dosage was 0.0029 mg/kg/day based on nominal infant body weight of 6 kg. approximately 70% of the total amount of lemborexant excreted in milk was excreted by 24 hours after a single maternal dose administration. there are no data on the effects of lemborexant on the breastfed infant, the effects on milk production, or infant exposure after repeated maternal dosing of lemborexant. the safety and effectiveness of dayvigo have not been established in pediatric patients. 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 clinical studies ( 14.2 )].  because dayvigo can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see warning s and precautions ( 5.1 )] . exercise caution when using doses higher than 5 mg in patients ≥65 years old.  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 clinical pharmacology ( 12.3 )]. dayvigo has not been studied in patients with severe hepatic impairment. use in this population is not recommended [see dosage and administration ( 2.3 ), clinical pharmacology ( 12.3 )].   dayvigo exposure (auc and cmax ) 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 and administration ( 2.3 ), clinical pharmacology ( 12.3 )].   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 clinical pharmacology ( 12.3 )]. obstructive sleep apnea (osa) the respiratory depressant effect of dayvigo was evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 37 patients with mild osa (apnea-hypopnea index < 15 events per hour of sleep). following once daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the apnea-hypopnea index was -0.06 (95% ci: -1.95 to 1.83). dayvigo was also evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 33 patients with moderate to severe osa (apnea-hypopnea index ≥ 15 events per hour of sleep). following once daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the apnea-hypopnea index was -0.80 (95% ci: -4.88 to 3.29). due to study limitations, including the short duration of the study, clinically meaningful respiratory effects of dayvigo in osa cannot be excluded, including for long-term treatment [see warnings and precautions ( 5.4 )] . chronic obstructive pulmonary disease (copd) the respiratory depressant effect of dayvigo was evaluated after 8 consecutive nights of treatment with dayvigo 10 mg in a randomized, placebo-controlled, two-period crossover study in 30 patients with moderate to severe copd (forced expiratory volume in the first second (fev1 )/forced vital capacity (fvc) ratio ≤ 70% and 30% ≤ fev1 < 80% of predicted). following once-daily dosing of 10 mg, the mean treatment difference (dayvigo – placebo) on day 8 for the mean peripheral capillary oxygen saturation during sleep was 0.47 (95% ci: 0.07 to 0.87). dayvigo has not been studied in copd patients with a fev1 < 30% of predicted. clinically meaningful respiratory effects of dayvigo in patients with compromised respiratory function cannot be excluded [see warnings and precautions ( 5.4 )] . dayvigo contains lemborexant, a schedule iv controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study conducted in recreational sedative abusers (n=29), lemborexant 10 mg, 20 mg (two times the maximum recommended dose), and 30 mg (three times the maximum recommended dose) produced responses on positive subjective measures such as “drug liking,” “overall drug liking,” “take drug again,” and “good drug effects” that were statistically similar to those produced by the sedatives zolpidem (30 mg) and suvorexant (40 mg), and statistically greater than the responses on these measures that were produced by placebo. because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to dayvigo, follow such patients carefully. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. in animal studies and clinical trials evaluating physical dependence, chronic administration of lemborexant did not produce withdrawal signs or symptoms upon drug discontinuation. this suggests that lemborexant does not produce physical dependence.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

eisai (malaysia) sdn bhd (18039-d) - lemborexant -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

eisai (malaysia) sdn bhd (18039-d) - lemborexant -

Australia - English - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - lemborexant, quantity: 5 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow - dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest diagnostic and statistical manual of mental disorders (dsm) criteria.

Australia - English - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - lemborexant, quantity: 10 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow; iron oxide red - dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest diagnostic and statistical manual of mental disorders (dsm) criteria.

Canada - English - Health Canada

eisai limited - lemborexant - tablet - 5mg - lemborexant 5mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

eisai limited - lemborexant - tablet - 10mg - lemborexant 10mg - miscellaneous anxiolytics sedatives and hypnotics

Israel - English - Ministry of Health

eisai israel ltd., israel - lemborexant - film coated tablets - lemborexant 10 mg - lemborexant - dayvigo is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

Israel - English - Ministry of Health

eisai israel ltd., israel - lemborexant - film coated tablets - lemborexant 5 mg - lemborexant - dayvigo is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

Singapore - English - HSA (Health Sciences Authority)

eisai (singapore) pte. ltd. - lemborexant - tablet, film coated - lemborexant 10 mg