Daridorexant (Quviviq) is a novel orexin receptor antagonist that was approved in the United States in January 2022 for the treatment of insomnia in adults, specifically targeting patients with difficulties in sleep onset and/or sleep maintenance. Although this medication has demonstrated favorable efficacy in clinical trials, caution must still be exercised regarding its potential side effects and precautions during use.

What Are the Side Effects of Daridorexant (Quviviq)?

Common Side Effects

Headache (incidence rate ≥ 5%).

Drowsiness or fatigue (incidence rate ≥ 5%).

Serious Side Effects of Daridorexant (Quviviq) Requiring Vigilance

CNS Depressive Effects and Daytime Functional Impairment

As a central nervous system (CNS) depressant, daridorexant may impair daytime alertness even when used as prescribed.

This depressive effect may persist for several days after discontinuing the medication in some patients.

Clinical studies have shown that a 50mg dose of daridorexant impairs the driving ability of some participants.

The risk significantly increases when daridorexant is used concomitantly with other CNS depressants (such as benzodiazepines, opioids, tricyclic antidepressants, and alcohol).

Worsened Depression/Suicidal Ideation

Insomnia patients themselves have a relatively high risk of depression and suicide.

The use of daridorexant may lead to worsening depressive symptoms or the emergence of suicidal thoughts, especially in patients who already have depressive symptoms.

Close monitoring of patients' emotional changes is necessary during clinical use, particularly in the early stages of treatment.

Sleep Paralysis and Hallucinatory-Like Symptoms

The use of daridorexant may cause sleep paralysis (inability to move or speak for several minutes during sleep-wake transitions) and vivid hypnagogic (pre-sleep) or hypnopompic (post-wake) hallucinations.

Complex Sleep Behaviors

Daridorexant may induce complex sleep behaviors, such as sleepwalking, sleep driving, eating, or engaging in other activities while not fully awake.

These behaviors may occur during the first dose or subsequent doses, and patients typically have no memory of these events.

The medication must be discontinued immediately if such behaviors occur.

Impact on Respiratory Function

For patients with pre-existing respiratory dysfunction (e.g., obstructive sleep apnea or COPD), daridorexant may further impair respiratory function.

Precautions for Daridorexant (Quviviq) Administration

Contraindications

Contraindicated in patients with narcolepsy.

Contraindicated in patients with hypersensitivity to daridorexant or any of its excipients.

Drug Interactions

Strong CYP3A4 Inhibitors (e.g., itraconazole): Concomitant use should be avoided.

Moderate CYP3A4 Inhibitors (e.g., diltiazem): The maximum dosage should not exceed 25mg per night.

CYP3A4 Inducers (e.g., rifampicin): Concomitant use should be avoided.

Alcohol and Other CNS Depressants: May cause additive effects and increase the risk of daytime functional impairment.

Other Precautions

If insomnia does not improve within 7-10 days of treatment, the diagnosis should be re-evaluated.

Avoid driving or operating hazardous machinery during the medication period.

Be alert to any newly emerging cognitive or behavioral abnormalities.