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Caution: DAYVIGO has a habit-forming effect.
Use only pursuant to the prescription or directions of a physician, etc.
Careful Administration (DAYVIGO should be administered with care in the following patients.): (1) Patients with mild and moderate hepatic function disorder (plasma lemborexant concentration may increase.) (See Pharmacology: PHARMACOKINETICS under Actions.)
(2) Patients with severe renal impairment (plasma lemborexant concentration may increase.) (See Pharmacology: PHARMACOKINETICS under Actions.)
(3) Patients with organic brain disorders (effects of DAYVIGO may excessively increase.)
(4) Patients with moderate and severe respiratory function disorder (DAYVIGO has never been administered to these patients, and safety has not been established) (See Pharmacology: Pharmacodynamics: CLINICAL STUDIES under Actions.)
Important Precaution(s): (1) The effects of DAYVIGO may persist until the next morning (or longer) after ingestion, and this product may induce drowsiness as well as impairment of attention, concentration, and reflex movements, so patients should be cautioned against engaging in potentially hazardous activities such as operating machinery or driving a motor vehicle.
(2) When symptoms improve, consider the necessity of continuing DAYVIGO, and take care that DAYVIGO is not aimlessly administered.
Precautions Concerning Use: At the time of drug delivery: Instruct the patient to take the drug in the press-through package (PTP) out of the PTP sheet before taking it. Accidental ingestion of a PTP sheet may lead to damage to the esophageal mucous membrane by hard, sharp edges, and furthermore, may cause perforation resulting in serious complications such as mediastinitis.
CNS Depressant Effects and Daytime Impairment: DAYVIGO is a 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. 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. 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. 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 sleepwalking, 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. 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).
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.
Missed Dose: If a patient misses a dose, the patient should be instructed not to take DAYVIGO unless there is an opportunity to sleep for at least 7 hours before being active again. They may continue with their usual dose the following night.
Use in Children: Clinical study in pediatric patients has not been performed.
Use in the Elderly: A pharmacokinetic study involving the elderly has revealed a tendency towards increases in plasma concentrations in the elderly compared to those in non-elderly individuals. Given that physiological functions of the elderly are decreased in general, administer DAYVIGO carefully while monitoring the status of the patient. (See Pharmacology: PHARMACOKINETICS under Actions.)
