Concise Prescribing Info
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, immediately before going to bed, w/ at least 7 hr remaining before the planned time of awakening. Max recommended dose: 10 mg based on clinical response & tolerability. Time to sleep onset may be delayed if taken w/ or soon after a meal. Patient w/ moderate hepatic impairment & co-administration w/ weak CYP3A inhibitors Max recommended dose: 5 mg no more than once per night.
Special Precautions
Initiate treatment of insomnia only after careful patient evaluation for psychiatric &/or medical disorder. Increased risk for abuse & addiction in individuals w/ a history of abuse or addiction to alcohol or other drugs. Can impair daytime wakefulness. CNS depressant effects may persist for up to several days after discontinuation in some patients. Potential for next-day somnolence. Sleep paralysis, hypnagogic/hypnopompic hallucinations, & cataplexy-like symptoms can occur. Discontinue immediately if patient experiences a complex sleep behaviour (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. 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. Increased risk of CNS depression w/ other CNS depressants (eg, benzodiazepines, opioids, TCAs, alcohol). Not recommended to use w/ other drugs to treat insomnia. Avoid alcohol consumption w/ Dayvigo. Avoid concomitant use w/ strong or moderate CYP3A inhibitors/inducers. Patients w/ COPD or moderate to severe obstructive sleep apnea. May impair ability to drive or operate machinery. Patients, particularly the elderly, are at a higher risk of falls. Not recommended in patients w/ severe hepatic impairment. Patients w/ mild hepatic impairment &/or severe renal impairment may have increased risk of somnolence. Pregnancy & lactation. Monitor for excessive sedation in infants exposed through breastmilk. Ped patients. Exercise caution when using doses >5 mg in patients ≥65 yr.
Adverse Reactions
Drug Interactions
Increased risk of adverse reactions w/ strong (eg, itraconazole, clarithromycin), moderate (eg, fluconazole, verapamil), or weak (eg, chlorzoxazone, ranitidine) CYP3A inhibitors. Reduced efficacy w/ strong (eg, rifampin, carbamazepine, St. John's wort) or moderate (eg, bosentan, efavirenz, etravirine, modafinil) CYP3A inducers. Greater negative impact on postural stability & memory w/ alcohol. Reduced efficacy of CYP2B6 substrates (eg, bupropion, methadone).
ATC Classification
N05CM - Other hypnotics and sedatives ; Used as hypnotics and sedatives.
Dayvigo FC tab 5 mg
2 × 14's
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