Dayvigo

/ Eisai Israel Ltd

The recommended dosage of this medical product 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.
Hepatic Impairment
The maximum recommended dose of Lemborexant is 5 mg no more than once per night in patients with moderate hepatic impairment. Is not recommended in patients with severe hepatic impairment
See prescribing information for full details.

Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

* Narcolepsy
* Hypersensitivity to the active substance or to any of the excipients

CNS Depressant Effects and Daytime Impairment
Lemborexant 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 this medical product. Advise patients about the potential for next-day somnolence.
Driving ability was impaired in some subjects taking Lemborexant 10 mg. The risk of daytime impairment is increased if Lemborexant is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken.
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 Lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of Lemborexant with other drugs to treat insomnia is not recommended. Patients should be advised not to consume alcohol in combination with Lemborexant because of additive effects. Because Lemborexant 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 Lemborexant.
Symptoms similar to mild cataplexy can occur with Lemborexant. 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 Lemborexant. 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, with or without the concomitant use of alcohol and other CNS depressants. Discontinue this medical product immediately if a patient experiences a complex sleep behavior.
Patients with Compromised Respiratory Function
Lemborexant 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 Lemborexant on respiratory function should be considered if prescribed to patients with compromised respiratory function.
Worsening of Depression/Suicidal Ideation
In clinical studies of Lemborexant in patients with insomnia, the incidence of suicidal ideation or any suicidal behavior, as assessed by questionnaire, was higher in patients receiving Lemborexant than in those receiving placebo (0.3% for Lemborexant 10 mg, 0.4% for Lemborexant 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 Lemborexant.

Most Common: The most common adverse reaction (reported in 5% or more and at least twice the rate of placebo) in Study 1 (the first 30 days) and Study 2 was somnolence (10% for Lemborexant 10 mg, 7% for Lemborexant 5 mg, and 1% for placebo).
See prescribing information for full details.

Effect of Other Drugs on Lemborexant
Strong, Moderate, and Weak CYP3A Inhibitors
Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and Cmax which may increase the risk of Lemborexant adverse reactions.
Avoid concomitant use.
The maximum recommended dose of Lemborexant with weak CYP3A inhibitors is 5 mg.
Strong and Moderate CYP3A Inducers
Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce this medical product efficacy.
Avoid concomitant use.
Alcohol
Concomitant use of alcohol increases lemborexant Cmax and AUC. Co-administration of Lemborexant with alcohol produced a numerically greater negative impact on postural stability and memory as compared with alcohol alone when assessed near the tmax of Lemborexant (2 hours post-dose). Avoid alcohol consumption.
Effect of Lemborexant on Other Drugs
CYP2B6 Substrates
Concomitant use of Lemborexant decreases the AUC of drugs that are CYP2B6 substrates, which may result in reduced efficacy for these concomitant medications.
Patients receiving Lemborexant and CYP2B6 substrates concurrently should be monitored for adequate clinical response. Increasing the doses of CYP2B6 substrates may be considered as needed.

Pregnancy: There are no available data on this medical product use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Lactation: 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. There are no data on the effects of lemborexant on the breastfed infant, or the effects on milk production. Infants exposed to Lemborexant 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 this medical product and any potential adverse effects on the breastfed infant from Lemborexant or from the underlying maternal condition.
See prescribing information for full details.

There is limited clinical experience with Lemborexant overdose. In clinical pharmacology studies, healthy patients who were administered multiple doses of up to 75 mg (7.5 times the maximum recommended dose) of Lemborexant showed dose-dependent increases in the frequency of somnolence.
There is no available specific antidote to an overdose of Lemborexant. In the event of overdose, standard medical practice for the management of any overdose should be used. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement.
The value of dialysis in the treatment of overdosage has not been determined with lemborexant. As lemborexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of lemborexant.