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: 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.
(3) 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).
(4) Worsening of depression/suicidal ideation: In clinical studies of DAYVIGO in patients with insomnia, the incidence of suicidal ideation or any suicidal behaviour, 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 behavioural sign or symptom of concern requires careful and immediate evaluation.
(5) Complex sleep behaviours: Complex sleep behaviours, 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 behaviours may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants (see Interactions).
Discontinue DAYVIGO immediately if a patient experiences a complex sleep behaviour.
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.
Use in Pregnancy & Lactation: (1) Pregnant or possibly pregnant women should receive DAYVIGO only when the benefit of treatment is considered to outweigh the risks. (Safety of use during pregnancy has not been established.)
(2) Avoid treating lactating women with DAYVIGO. When there is no other choice but to administer the drug, instruct them to stop breastfeeding. (Lemborexant and its metabolites transfer to breast milk in lactating rats.)
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.)