PharmaceuticalHypnoticDual orexin receptor antagonistSchedule IV

Daridorexant

Also known as Quviviq · ACT-541468 · nemorexant

Written by enwyReviewed 5 Aug 20262 sources0 comments

Newest dual orexin receptor antagonist, approved 2022, engineered with a shorter half-life to improve sleep while minimising next-morning residual effects. Schedule IV; improves both onset and maintenance with daytime functioning benefits.

01 Overview

Daridorexant (brand Quviviq) was approved by the FDA in 2022 as a dual orexin receptor antagonist for insomnia characterised by problems with onset and/or maintenance. It was deliberately designed with a shorter half-life (~8 h) than suvorexant or lemborexant to deliver a full night of sleep while limiting next-day carryover.

Pivotal trials showed improvements in sleep onset, wake after sleep onset, and, notably, patient-reported daytime functioning. It is a Schedule IV controlled substance. Like other DORAs it carries the class warning for complex sleep behaviours and can still cause some next-day somnolence, though generally less than the longer-acting agents.

02 Mechanism

Reversible dual antagonist at orexin OX1 and OX2 receptors, blocking the wake-promoting orexin/hypocretin system with a relatively short duration of action.

03 Dosing

Tier	Dose	Route	Notes
Standard	25 mg/day	Oral	25 mg within 30 min of bed with >=7 h remaining.
Maximum	50 mg/day	Oral	May increase to 50 mg; max 50 mg once nightly.

04 Effects

Effect	Magnitude	Evidence
Improved sleep onset and maintenanceReduces latency to persistent sleep and wake after sleep onset.	~30 min less WASO at 50 mg	Clinical
Improved daytime functioningTrials showed benefit on patient-reported daytime sleepiness/functioning, a distinguishing endpoint.		Clinical

05 Side effects

Effect	Severity	Frequency	Evidence
Next-day somnolenceResidual drowsiness or fatigue, typically less than with longer-acting DORAs.	Mild	Common but generally mild	Clinical
HeadacheHeadache reported more often than placebo.	Mild	Common	Clinical
Complex sleep behavioursSleep-walking, sleep-driving, and related parasomnias without memory.	Severe	Rare	Clinical

06 Legal status

EMA-approved 2022 for chronic insomnia. · as of Jan 2026

United States

Schedule IV

FDA-approved 2022; DEA Schedule IV. · as of Jan 2026

07 References

Daridorexant, a new dual orexin receptor antagonist, in insomnia disorder (phase 3)Lancet Neurology, 2022

Quviviq (daridorexant) FDA prescribing informationUS FDA

08 Discussion0 comments

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This page is reference information, not medical advice. Doses and protocols are documented as they appear in the clinical literature and in practice — describing them is not a recommendation to use them. Countermeasures listed here are not a substitute for a physician. Legal status varies by jurisdiction and changes.