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Safety Information

INDICATION AND CLINICAL USE

Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made
after the patient has been carefully evaluated.

DAYVIGO™ (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep
onset and/or sleep maintenance.

DAYVIGO™ is not recommended for patients under the age of 18 years.

DAYVIGO™ is not recommended in patients with severe hepatic impairment.

CONTRAINDICATIONS

Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or
component of the container.

Patients with narcolepsy.

RELEVANT WARNINGS AND PRECAUTIONS

Abnormal thinking and behavioural changes

CNS depressant effects (including alcohol) and daytime impairment

Complex sleep behaviours

Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms

Worsening of depression/suicidal ideation

Co-morbid diagnoses

Drug interactions – inhibitors and inducers of CYP3A

Patients with galactose intolerance

Driving and operating machinery

Patients with dependence/tolerance and abuse liability

Patients with hepatic impairment

Patients with compromised respiratory function

Pregnant or breastfeeding women

FOR MORE INFORMATION

Please see the Product Monograph for important information on adverse reactions, drug interactions, and dosing
not discussed in this piece.


Sleep disturbance may be the presenting manifestation of a physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the
patient has been carefully evaluated.

DAYVIGO™ is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance.

Click here for additional safety information and for a link to the product monograph, discussing
contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical
use.