Dayvigo Patient Counseling Information

Advise the patient to read the approved patient labeling (Medication Guide).
Administration Instructions: Advise patients to take DAYVIGO only when preparing for or getting into bed and only if they can stay in bed for a full night (at least 7 hours) before being active again [see Dosing Information under Dosage & Administration].
Advise patients that the effect of DAYVIGO may be delayed if taken with or soon after a meal [see Pharmacology: Pharmacokinetics under Actions; Dosing Information under Dosage & Administration].
CNS Depressant Effects and Daytime Impairment: Advise patients that DAYVIGO can impair daytime wakefulness even when used as prescribed. The risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken. If DAYVIGO is taken in these circumstances, caution patients against driving and other activities requiring complete mental alertness. Advise patients that increased drowsiness may increase the risk of falls in some patients [see CNS Depressant Effects and Daytime Impairment under Precautions].
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms: Advise patients and their families that DAYVIGO may cause sleep paralysis, which is an inability to move or speak for several minutes during sleep-wake transitions, despite being aware of surroundings; hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions; and symptoms similar to mild cataplexy [see Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms under Precautions].
Complex Sleep Behaviors: Instruct patients and their families that DAYVIGO may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Tell patients to discontinue DAYVIGO and notify their healthcare provider immediately if they develop any of these symptoms [see Complex Sleep Behaviors under Precautions].
Worsening of Depression/Suicidal Ideation: Tell patients to report any worsening of depression or suicidal thoughts immediately [see Worsening of Depression/Suicidal Ideation under Precautions].
Concomitant Medications: Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to consume alcohol in combination with DAYVIGO [see Pharmacology: Pharmacokinetics under Actions; Drugs Having Clinically Important Interactions with DAYVIGO under Interactions].
Tolerance, Abuse, and Dependence: Tell patients not to increase the dose of DAYVIGO on their own, and to inform if they believe the drug "does not work" [see Drug Abuse and Dependence under Precautions].