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.

Frequently asked questions

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