Daridorexant Application Scope

Daridorexant is a dual orexin receptor antagonist indicated for the treatment of adult patients with insomnia characterised by difficulties with sleep onset and/or sleep maintenance.

daridorexant

Daridorexant Characteristics

Ingredients:
- Active Ingredient: Daridorexant hydrochloride.
- Inactive Ingredients: Croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide. The tablet film coating contains glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.
Properties:
- Quviviq functions as a dual orexin receptor antagonist, reducing wakefulness by blocking the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors.
Specification:
- Available in 25 mg and 50 mg film-coated tablets.
Packaging Specification:
- Supplied in blister packs containing 30 tablets.
Storage:
- Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Expiry Date:
- Refer to the packaging for the expiration date.
Executive Standard:
- Approved by the U.S. Food and Drug Administration (FDA) under New Drug Application (NDA) number 214985.
Approval Number:
- NDA 214985.
Date of Revision:
- Refer to the latest prescribing information for the most current revision date.
Manufacturer:
- Idorsia Pharmaceuticals Ltd.

Guidelines for the Use of Daridorexant

Dosage and Administration:
- The recommended dosage is 25 mg to 50 mg taken orally once per night, within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening. The maximum dose is 50 mg once per night. Quviviq can be taken with or without food; however, taking it with or soon after a meal may delay its onset.
Adverse Reactions:
- The most common adverse reactions (reported in ≥5% of patients) include headache and somnolence or fatigue. Other potential adverse reactions involve sleep paralysis, hypnagogic/hypnopompic hallucinations, and symptoms similar to mild cataplexy.
Contraindications:
- Quviviq is contraindicated in patients with narcolepsy.
Precautions:
- CNS Depressant Effects and Daytime Impairment: Daridorexant may impair daytime wakefulness and increase the risk of falls, particularly in elderly patients. Caution patients against driving and other activities requiring full mental alertness the day after use.
- Worsening of Depression and Suicidal Ideation: Monitor patients for signs of depression or suicidal thoughts. Use with caution in patients with psychiatric disorders.
- Complex Sleep Behaviors: Discontinue daridorexant immediately if a patient experiences complex sleep behaviors such as sleepwalking or sleep-driving.
- Patients with Compromised Respiratory Function: Use with caution in patients with compromised respiratory function; daridorexant has not been studied in patients with severe obstructive sleep apnea or chronic obstructive pulmonary disease (COPD).
- Abuse Potential and Dependence: Monitor patients with a history of substance abuse closely, as daridorexant has abuse potential.

Daridorexant Interactions

- Drug Interactions:
  - CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole) is contraindicated. For moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin), the recommended dose is 25 mg once per night.
  - CYP3A4 Inducers: Concomitant use with strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine) is not recommended, as they may decrease the efficacy of daridorexant.
  - CNS Depressants: Concomitant use with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution should be exercised when combining daridorexant with other CNS depressants.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.