DAYVIGO

DAYVIGO- lemborexant tablet, film coated
Eisai Inc.

1 INDICATIONS AND USAGE

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)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dosage of DAYVIGO is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal [see Clinical Pharmacology ( 12.3)].

2.2 Dosage Recommendations for Concomitant Use with CYP3A Inhibitors or CYP3A Inducers

Co-administration with Strong or Moderate CYP3A Inhibitors

Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Drug Interactions ( 7.1), Clinical Pharmacology ( 12.3)].

Co-administration with Weak CYP3A Inhibitors

The maximum recommended dosage of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors [see Drug Interactions ( 7.1), Clinical Pharmacology ( 12.3)].

Co-administration with Strong or Moderate CYP3A Inducers

Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Drug Interactions ( 7.1), Clinical Pharmacology ( 12.3)].

2.3 Dosage Recommendations for Patients with Hepatic Impairment

The maximum recommended dose of DAYVIGO is 5 mg no more than once per night in patients with moderate hepatic impairment [see Use in Specific Populations ( 8.7), Clinical Pharmacology ( 12.3)].

DAYVIGO is not recommended in patients with severe hepatic impairment [see Use in Specific Populations ( 8.7)].

3 DOSAGE FORMS AND STRENGTHS

DAYVIGO (lemborexant) tablets are available as:

• 5 mg tablets: pale yellow, round, biconvex, film-coated tablets, and debossed with “5” on one side and “LЄM” on the other side.
  
• 10 mg tablets: orange, round, biconvex, film-coated tablets, and debossed with “10” on one side and “LЄM” on the other side.

4 CONTRAINDICATIONS

DAYVIGO is contraindicated in patients with narcolepsy.

5 WARNINGS AND PRECAUTIONS

5.1 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 Clinical Studies ( 14.2)]. 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 Dosage and Administration ( 2.1)]. 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 Drug Interactions ( 7.1)].

Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.

5.2 Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy – l ike 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).

5.3 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 Drug Interactions ( 7.1)]. Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.

5.4 Patients with Compromised Respiratory Function

​ DAYVIGO has been studied in mild to severe Obstructive Sleep Apnea (OSA) and moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in short-term clinical trials. The effect of DAYVIGO on respiratory function should be considered if prescribed to patients with compromised respiratory function [see Use in Speci fic Populations ( 8.8)].

5.5 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.

5.6 Need to Evaluate for Co-m orbid 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.