Dayvigo

Dayvigo

lemborexant

Manufacturer:

Eisai

Distributor:

Zuellig

Marketer:

HI-Eisai
Concise Prescribing Info
Contents
Lemborexant
Dosage/Direction for Use
5 mg no more than once per night & w/in a few min before going to bed, w/ at least 7 hr remaining before the planned time of awakening. May be increased to 10 mg once daily if dose is well-tolerated but greater effect is needed. Max: 10 mg once daily. Moderate hepatic impairment & co-administration w/ weak CYP3A inhibitors Max: 5 mg once daily.
Administration
Should be taken on an empty stomach: Time to sleep onset may be delayed if taken w/ or soon after a meal.
Contraindications
Special Precautions
Avoid alcohol consumption; concomitant use w/ moderate or strong CYP3A inhibitors & inducers. Patients w/ COPD or moderate to severe obstructive sleep apnea. May impair daytime wakefulness. Advice patients about the potential next-day somnolence. Not recommended to use w/ other drugs for insomnia. Individuals w/ history of abuse or addiction to alcohol or other drugs. May impair ability to drive & use machines. Not recommended in severe hepatic impairment. Pregnancy. Not to be used during lactation. Not recommended in ped patients (<18 yr).
Adverse Reactions
Somnolence, UTI, fatigue. Sleep paralysis.
Drug Interactions
Increased AUC exposure w/ moderate (eg, fluconazole) or strong (eg, itraconazole) CYP3A inhibitors; weak CYP3A inhibitors (eg, fluoxetine). Reduction in systemic exposure resulting to decreased efficacy w/ moderate or strong CYP3A inducers. Increased Cmax & AUC w/ alcohol.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CJ02 - lemborexant ; Belongs to the class of orexin receptor antagonists. Used as hypnotics.
Presentation/Packing
Form
Dayvigo FC tab 5 mg
Packing/Price
28's (P89/film-coated tab)
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