Daridorexant

QUVIVIQ

What it isDual orexin receptor antagonist; insomnia.

Why this oneThe shortest half-life of the orexin antagonists, so next-morning impairment is least.

What limits itSomnolence remains, and seven hours must remain before waking. CYP3A4-dependent; Schedule IV.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Insomnia (sleep onset and/or maintenance)	Adults	25-50 mg QHS	25-50 mg QHS	50 mg QHS

Renal Undefined

Hepatic Moderate (Child-Pugh 7-9): max 25 mg QHS. Severe (>=10): not recommended.

No more than once per night.

Take orally within 30 minutes before bed, with at least 7 hours remaining before planned awakening.
Onset may be delayed if taken with or soon after a meal.
With moderate CYP3A4 inhibitors: max 25 mg; avoid strong CYP3A4 inhibitors and strong/moderate CYP3A4 inducers.

CNS-depressant effects / next-day daytime impairment (driving); additive with other CNS depressants
Worsening depression / suicidal ideation
Sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms
Complex sleep behaviors (sleepwalking/driving) — discontinue if they occur
Compromised respiratory function

Pregnancy No human data; pregnancy exposure registry available.

Lactation Present in human milk in low amounts (<1% RID); monitor breastfed infant for excessive sedation.

NO BOXED WARNINGS

Principal riskSomnolence; allow seven hours before waking

Cost, est. cash$300–$2,500/month

Generic entry2034 est.

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability3 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityNext-day somnolence, abnormal sleep behaviors and additive CNS depression.

CYP3A4 substrate