DARIDOREXANT

Other

Brand names: QUVIVIQ

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Indications

1 INDICATIONS AND USAGE QUVIVIQ is indicated for the treatment of adult patients with insomnia

characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment
Risk increases when used with other central nervous system (CNS) depressants
The risk of daytime impairment is increased if QUVIVIQ is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken [see Dosage and Administration (2
, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment

Known Side Effects

7 documented side effects by frequency

Drug Not Working

>10%

Insomnia

>10%

Drowsiness

1-10%

Fatigue

1-10%

Headache

1-10%

Nausea

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral