Last reviewed 2026-04-23 · How we verify

ACT-541468

ACT-541468 is a selective orexin receptor antagonist.

ACT-541468 is a selective orexin receptor antagonist. Used for Insomnia.

At a glance

Mechanism of action

It works by blocking the action of orexin, a neurotransmitter involved in regulating arousal, wakefulness, and appetite. This can help reduce symptoms of insomnia and other sleep disorders.

Approved indications

• Insomnia

Common side effects

• Headache
• Nausea
• Dizziness

Key clinical trials

• A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder (PHASE3)
• A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep (PHASE1)
• Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (PHASE3)
• Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder (PHASE3)
• Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (PHASE3)
• A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects (PHASE1)
• Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects (PHASE1)
• A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment (PHASE1)

Primary sources

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