Dayvigo

Dayvigo

lemborexant

Manufacturer:

Eisai

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Lemborexant
Indications/Uses
Insomnia characterized by sleep onset difficulties &/or maintenance.
Dosage/Direction for Use
Adult 5 mg once daily immediately before bedtime, w/ at least 7 hr remaining before planned awakening time. Max: 10 mg once daily. Moderate hepatic impairment & co-administration w/ weak CYP3A inhibitor Max: 5 mg once daily.
Administration
Should be taken on an empty stomach: Take immediately before going to bed. Time to sleep onset may be delayed if taken w/ or soon after a meal.
Contraindications
Hypersensitivity. Narcolepsy. Concomitant use w/ strong or moderate CYP3A inhibitors. Severe hepatic impairment.
Special Precautions
Avoid use at the same time or right after meals since sleep induction may be delayed. Patients w/ organic brain disorders; moderate & severe resp function disorders. Consider the necessity of continuing use when symptoms improve & ensure that Dayvigo is not aimlessly administered. Sleep paralysis, hypnagogic/hypnopompic hallucinations & mild cataplexy-like symptoms. Worsening of depression/suicidal ideation; immediately evaluate emergence of any new behavioural sign or symptom of concern. Immediately discontinue use if patient experiences complex sleep behaviours including sleep-walking, sleep-driving & engaging in other activities while not fully awake. Concomitant use w/ other drugs for insomnia. May induce drowsiness, impairment of attention, concentration & reflex movements; avoid potentially hazardous activities (eg, operating machinery or driving a motor vehicle). Mild & moderate hepatic impairment. Severe renal impairment. Pregnant or possibly pregnant women. Avoid use in lactating women; stop breastfeeding when there is no other choice but to administer the drug. Childn. Elderly.
Adverse Reactions
Drug Interactions
Incidence of AR may be increased w/ moderate & strong CYP3A inhibitors (eg, itraconazole, clarithromycin, erythromycin, fluconazole, verapamil). Effects may be increased by weak CYP3A inhibitors (eg, ranitidine). Effects may be decreased by CYP3A inducers (eg, rifampicin, phenytoin). May enhance CNS depressant effects of phenothiazine & barbiturate derivatives. Additive decreases in psychomotor functions w/ alcohol.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CM21 - lemborexant ; Belongs to the class of other hypnotics and sedatives.
Presentation/Packing
Form
Dayvigo FC tab 5 mg
Packing/Price
28's
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