Sign Out
CNS Depressant Effects and Daytime Impairment: DAYVIGO is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. CNS depressant effects may persist in some patients for up to several days after discontinuing DAYVIGO. Prescribers should advise patients about the potential for next-day somnolence.
Driving ability was impaired in some subjects taking DAYVIGO 10 mg [see Pharmacology: Pharmacodynamics: Clinical Studies: Special Safety Studies under Actions]. The risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken [see Dosing Information under Dosage & Administration]. If DAYVIGO is taken in these circumstances, patients should be cautioned against driving and other activities requiring complete mental alertness.
Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of DAYVIGO and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of DAYVIGO with other drugs to treat insomnia is not recommended. Patients should be advised not to consume alcohol in combination with DAYVIGO because of additive effects [see Drugs Having Clinically Important Interactions with DAYVIGO under Interactions].
Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with the use of DAYVIGO. Prescribers should explain the nature of these events to patients when prescribing DAYVIGO.
Symptoms similar to mild cataplexy can occur with DAYVIGO. Such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with an identified triggering event (e.g., laughter or surprise).
Complex Sleep Behaviors: Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants [see Drugs Having Clinically Important Interactions with DAYVIGO under Interactions]. Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.
Patients with Compromised Respiratory Function: The effect of DAYVIGO on respiratory function should be considered if prescribed to patients with compromised respiratory function. DAYVIGO has not been studied in patients with moderate to severe obstructive sleep apnea (OSA) or in patients with chronic obstructive pulmonary disease (COPD).
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.
Worsening of Depression/Suicidal Ideation: In clinical studies of DAYVIGO in patients with insomnia, the incidence of suicidal ideation or any suicidal behavior, as assessed by questionnaire, was higher in patients receiving DAYVIGO than in those receiving placebo (0.3% for DAYVIGO 10 mg, 0.4% for DAYVIGO 5 mg, and 0.2% for placebo).
In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed at any one time.
The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Need to Evaluate for Co-morbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a medical and/or psychiatric disorder, treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or medical disorder and can emerge during the course of treatment with sleep-promoting drugs such as DAYVIGO.
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: Pharmacokinetics: Specific Populations under Actions].
Hepatic Impairment: DAYVIGO has not been studied in patients with severe hepatic impairment. Use in this population is not recommended [see Pharmacology: Pharmacokinetics: Specific Populations under Actions; Dosage Recommendations for Patients with Hepatic Impairment under Dosage & Administration].
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 Pharmacology: Pharmacokinetics: Specific Populations under Actions; Dosage Recommendations for Patients with Hepatic Impairment under Dosage & Administration].
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: Pharmacokinetics: Specific Populations under Actions].
Drug Abuse and Dependence: Abuse: 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.
Dependence: 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.
Use in Children: The safety and effectiveness of DAYVIGO have not been established in pediatric patients.
Use in the Elderly: 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: Special Safety Studies under Actions]. Because DAYVIGO can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see CNS Depressant Effects and Daytime Impairment as previously mentioned]. Exercise caution when using doses higher than 5 mg in patients ≥65 years old.
