Dayvigo

Dayvigo

lemborexant

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Lemborexant
Indications/Uses
Insomnia characterized by sleep onset &/or maintenance difficulties.
Dosage/Direction for Use
Adult 5 mg once daily immediately before bedtime w/ at least 7 hr remaining before planned awakening time. May be increased to max: 10 mg. Moderate hepatic impairment & co-administration w/ weak CYP3A inhibitor Max: 5 mg once daily.
Administration
Should be taken on an empty stomach: Onset may be delayed if taken w/ or soon after a meal.
Special Precautions
Discontinue use if complex sleep behaviour eg, sleep-walking & driving & engaging in other activities while not fully awake is experienced. Worsening of depression or suicidal ideation. Patients w/ compromised resp function, mild to severe obstructive sleep apnea or moderate to severe COPD. CNS depressant effects & daytime impairment; sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms. History of alcohol or drug abuse/addiction. Evaluate for co-morbid diagnosis. Avoid alcohol consumption. Not recommended to use w/ other anti-insomnia drugs. Avoid concomitant use w/ strong or moderate CYP3A inhibitors & inducers. Co-administration w/ other CNS depressants eg, benzodiazepines, opioids, TCAs. May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Mild to moderate hepatic & severe renal impairment. Pregnancy & lactation. Ped <18 yr. Elderly ≥65 yr.
Adverse Reactions
Somnolence or fatigue, headache, nightmares or abnormal dreams.
Drug Interactions
Increased risk of ARs w/ strong (eg, itraconazole, clarithromycin), moderate (eg, fluconazole, verapamil) & weak (eg, chlorzoxazone, ranitidine) CYP3A inhibitors. Reduced efficacy w/ strong (eg, rifampin, carbamazepine, St. John's wort) or moderate (eg, bosentan, efavirenz, etravine, modafinil) CYP3A inducers. Increased Cmax & AUC by alcohol. Reduced efficacy of CYP2B6 substrates eg, bupropion, methadone.
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
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