Dayvigo

Dayvigo

lemborexant

Manufacturer:

Eisai
Concise Prescribing Info
Contents
Lemborexant
Dosage/Direction for Use
Adult 5 mg once daily immediately before bedtime. Moderate hepatic impairment & co-administration w/ weak CYP3A inhibitor Max: 5 mg once daily. Dosage adjustment may be necessary when combined w/ other CNS depressants. Missed dose: Patient should not take Dayvigo unless there is an opportunity to sleep for at least 7 hr before being active again, & then continue w/ the usual dose the following night.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity. Patients w/ narcolepsy. Concomitant use w/ strong or moderate CYP3A inhibitors & inducers. Severe hepatic impairment.
Special Precautions
Habit-forming effect. Should not be taken if there is any possibility of waking up temporarily in the middle of sleep to engage in activities (eg, work). 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. May impair daytime wakefulness. CNS depressant effects may persist for up to several days after discontinuation in some patients. Potential for next-day somnolence. Co-administration w/ other CNS depressants eg, benzodiazepines, opioids, TCAs. Not recommended to use w/ other drugs to treat insomnia. Avoid alcohol consumption. Sleep paralysis, hypnagogic/hypnopompic hallucinations, & cataplexy-like symptoms can occur. Discontinue immediately if patient experiences a complex sleep behavior (eg, sleep-walking, sleep-driving & engaging in other activities while not fully awake). Consider effect on resp function if prescribed to patients w/ compromised resp function; moderate to severe obstructive sleep apnea or COPD. Worsening of depression & suicidal thoughts & actions (including completed suicides) in primarily depressed patients treated w/ hypnotics; lowest feasible number of tab should be prescribed at any one time to prevent intentional overdose. Initiate treatment of insomnia only after careful patient evaluation for medical &/or psychiatric disorder. May induce drowsiness, impairment of attention, conc & 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. Ped patients. Elderly.
Adverse Reactions
Drug Interactions
Incidence of AR may be increased w/ strong or moderate CYP3A inhibitors (eg, itraconazole, clarithromycin, erythromycin, fluconazole, verapamil). Effects may be decreased by strong or moderate CYP3A inducers (eg, rifampicin, phenytoin). Effects may be increased by weak CYP3A inhibitors (eg, chlorzoxazone, ranitidine). Reduced efficacy of CYP2B6 substrates (eg, bupropion, methadone). 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
2 × 14's
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