What is the recommended dosing regimen for Quiviviq (Daridorexant) for the treatment of insomnia?

Quiviviq (Daridorexant) Dosing for Insomnia Treatment

The recommended dosage of Quiviviq (Daridorexant) for treating insomnia is 25 mg to 50 mg taken orally once per night within 30 minutes of going to bed, with at least 7 hours remaining before planned awakening. 1

Dosing Guidelines

• The FDA-approved dosing range is 25 mg to 50 mg taken once daily at bedtime 1
• 50 mg is the preferred dose for most patients as it provides the greatest efficacy with no increased risk of adverse events compared to lower doses 2
• Quiviviq should be taken within 30 minutes of going to bed with at least 7 hours remaining before planned awakening 1
• Time to sleep onset may be delayed if taken with or soon after a meal 1

Dosage Adjustments

Hepatic Impairment

• For patients with moderate hepatic impairment (Child-Pugh score 7-9): Maximum dose is 25 mg once daily 1
• Not recommended for patients with severe hepatic impairment (Child-Pugh score ≥10) 1

Drug Interactions

• With moderate CYP3A4 inhibitors: Reduce dose to 25 mg once daily 1
• Avoid concomitant use with strong CYP3A4 inhibitors 1
• Avoid concomitant use with strong or moderate CYP3A4 inducers 1
• Use caution when co-administering with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) as dosage adjustments may be necessary due to potentially additive effects 1

Efficacy Considerations

• Daridorexant is a dual orexin receptor antagonist (DORA) that reduces the wake drive 3
• The 50 mg dose has shown superior efficacy compared to placebo for:
  • Reducing wake time after sleep onset 4
  • Decreasing latency to persistent sleep 4
  • Improving subjective total sleep time 4
  • Enhancing daytime functioning 3, 4
• Efficacy is maintained during long-term treatment (up to 12 months) 3

Safety Considerations

• Most common adverse events include somnolence, fatigue, and dizziness, which occur at similar or slightly higher rates than placebo 3
• Most adverse events are mild in severity 3
• The incidence of adverse events is not dose-dependent 2
• Daridorexant may impair daytime wakefulness; patients should be advised about potential next-day somnolence 1
• Driving ability may be impaired in some patients taking the 50 mg dose 1

Important Precautions

• Contraindicated in patients with narcolepsy 1
• Contraindicated in patients with hypersensitivity to daridorexant or any components of Quiviviq 1
• Not recommended for use with other insomnia medications 1
• Use caution when prescribing to elderly patients 5

Clinical Pearls

• Daridorexant was designed with a half-life intended to minimize residual effects that might impair daytime functioning 6
• It appears to be safe and effective in treating insomnia in patients of all ages, including those ≥65 years 7
• Available in 25 mg and 50 mg tablets 1