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:
- Study 1 (NCT03545191)
- Study 2 (NCT03575104)
- Study 3 (NCT03679884)
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.
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