New Sleep Medication Approved: Daridorexant (Quviviq)

On Jan 10, 2022, FDA has approved this new medication for treatment of adults with insomnia: Quviviq (daridorexant). This FDA approval is based on the results of following studies:

We will discuss the clinically relevant facts about Quiviq in the following sections:

FDA APPROVED INDICATION:

  • Adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

MECHANISM OF ACTION:

  • Antagonism of orexin receptors.
  • Orexin neuropeptide signaling system plays a role in wakefulness ==> Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

RECOMMENDED DOSE:

  • 25 mg to 50 mg once per night.
  • taken orally within 30 minutes before going to bed
  • with at least 7 hours remaining prior to planned awakening.
  • For Moderate Hepatic Impairment: maximum recommended dosage is 25 mg no more than once per night.

CAN MEALS AFFECT QUVIVIQ ABSORPTION?

  • Yes: Time to sleep onset may be delayed if taken with or soon after a meal (high-fat and high-calorie meal).
  • In healthy subjects, a high-fat and high-calorie meal delayed the Tmax by 1.3 hours and decreased the Cmax by 16%, but did not affect the total exposure (AUC).

WHEN IS QUVIVIQ NOT RECOMMENDATION OR CONTRAINDICATED?

  • Not recommended: Severe hepatic impairment
  • Contraindication: Narcolepsy
  • Caution: Severe COPD or Obstructive Sleep Apnea (moderate OSA requiring CPAP or severe OSA): Quviviq is not studied for both conditions, but it’s effect on respiratory function should be considered. 

MOST COMMON ADVERSE REACTIONS:

  • Headache
  • Somnolence or fatigue

IMPORTANT DRUG INTERACTIONS: CYP3A4

  • Strong 3A4 Inhibitors: AVOID
  • Moderate 3A4 Inhibitors: 25 mg dose
  • Strong or Moderate 3A4 Inducers: AVOID

IMPORTANT WARNINGS FOR PATIENTS:

  • Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment.
  • Potential for next-morning driving impairment: do not drive or operate heavy machinery, if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.
  • In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported: so monitor for suicide risk after administration. 
  • Sleep paralysis and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with the use of QUVIVIQ.
  • Complex sleep behaviors, including sleepwalking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported.

REFERENCES:

  • Idorsia Media Release (pdf)
  • Package insert (pdf)

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