Daridorexant Dosage
Medically reviewed by Drugs.com. Last updated on Sep 27, 2024.
Applies to the following strengths: 25 mg; 50 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Insomnia
Recommended dose: 25 to 50 mg once per night, orally
Maximum dose: 50 mg
Comments:
- Take no more than once per night within 30 minutes of going to bed, and with at least 7 hours remaining prior to awakening.
- The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric or medical illness that should be evaluated.
Use: Treatment of adults with insomnia
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
- Mild liver dysfunction: No adjustment recommended.
- Moderate liver dysfunction (Child-Pugh score 7 to 9): Maximum recommended dose of 25 mg no more than once per night.
- Severe liver dysfunction: Not recommended.
Dose Adjustments
Co-administration with Moderate CYP450 3A4 inhibitors:
- Recommended dose: 25 mg no more than once per night
Co-administration with Strong CYP450 3A4 inhibitors: Avoid use
Co-administration with Strong or Moderate CYP450 3A4 inducers: Avoid use
Liver Dysfunction:
- Moderate liver dysfunction (Child-Pugh score 7 to 9): Maximum recommended dose of 25 mg no more than once per night.
- Severe liver dysfunction (Child-Pugh score equal or greater than 10): Not recommended.
Precautions
CONTRAINDICATIONS:
- Patients with narcolepsy
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule to be determine after review by the Drug Enforcement Administration.
Dialysis
Data not available
Other Comments
Administration advice:
- Initiate treatment only after careful evaluation of the patient. Failure to respond after 7 to 10 days of treatment may indicate the presence of a primary psychiatric or medical illness that should be evaluated.
- Should be taken orally no more than once per night within 30 minutes of going to bed.
- Should be taken with at least 7 hours of sleep remaining prior to planned awakening.
- Can be taken with or without food, however time to sleep onset may be delayed if taken with or soon after a meal.
- Advise patients about the potential for next-day somnolence. Caution against driving and doing other activities that require complete mental alertness.
- Particular caution is advised with elderly patients that are at higher risk of falls.
- Advise not to consume alcohol or take with other CNS depressants.
Storage requirements:
- Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (59F and 86F)
Monitoring:
- In patients with psychiatric disorders monitor new or worsening depression or appearance of suicidal thoughts.
- Monitor appearance of complex sleep behaviors such as sleepwalking, sleep driving or engaging in other activities while sleeping. Discontinue immediately if a patient experiences a complex sleep behavior.
- Monitor respiratory function in patients with obstructive sleep apnea or chronic obstructive pulmonary disease.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Take orally no more than once per night within 30 minutes of going to bed and with at least 7 hours of sleep remaining prior to your planned awakening.
- Take with or without food, however time to sleep onset may be delayed if taken with or soon after a meal.
- This drug causes next-day somnolence. Use caution if driving or doing any other activities that require complete mental alertness, especially if you are older than 65 years old.
- Do not consume alcohol or take with other CNS depressants.
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