Dayvigo

Dayvigo

lemborexant

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Lemborexant
Indications/Uses
Adults w/ insomnia, characterized by difficulties w/ sleep onset &/or sleep maintenance.
Dosage/Direction for Use
Recommended dose: 5 mg no more than once per night. Max: 10 mg. Co-administration w/ weak CYP3A inhibitors; moderate hepatic impairment 5 mg no more than once per night.
Administration
Should be taken on an empty stomach: Take immediately before going to bed, w/ at least 7 hr remaining before planned time of awakening.
Contraindications
Special Precautions
Discontinue use if patient experiences complex sleep behavior. Worsening of depression & suicidal thoughts & actions (including completed suicides); insomnia or emergence of new cognitive or behavioral abnormalities. Increased risk of CNS depression w/ other CNS depressants (eg, benzodiazepines, opioids, TCAs, alcohol). Patients w/ compromised resp function, moderate to severe obstructive sleep apnea or COPD. Symptoms similar to mild cataplexy may occur. Not to consume alcohol during treatment. Avoid concomitant use w/ strong or moderate CYP3A inhibitors/inducers. May impair ability to drive & other activities requiring complete mental alertness. Not recommended in patients w/ severe hepatic impairment. Increased risk of somnolence in patients w/ severe renal impairment. Pregnancy & lactation. Monitor infants exposed to treatment through breastmilk for excessive sedation. Childn. Exercise caution in elderly ≥65 yr when using doses >5 mg.
Adverse Reactions
Somnolence or fatigue, headache, sleep paralysis; abnormal dreams or nightmare.
Drug Interactions
Increased AUC & Cmax w/ strong CYP3A inhibitors eg, itraconazole, clarithromycin; moderate CYP3A inhibitors eg, fluconazole, verapamil; weak CYP3A inhibitors eg, chlorzoxazone, ranitidine; & alcohol. Decreased exposure w/ strong CYP3A inducers eg, rifampin, carbamazepine, St. John's wort; moderate CYP3A inducers eg, bosentan, efavirenz, etravirine, modafinil. Decreased AUC of CYP2B6 drugs 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
2 × 14's
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