Medically reviewed by Drugs.com. Last updated on May 23, 2022.
Applies to the following strengths: 5 mg; 10 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Insomnia
5 mg orally once a day at bedtime
- Maximum dose: 10 mg once at bedtime
Use: For the treatment of patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Mild liver dysfunction: No adjustment recommended.
Moderate liver dysfunction: Maximum dose 5 mg/day at bedtime
Severe liver dysfunction: Not recommended.
USE WITH STRONG OR MODERATE CYP450 3A4 INHIBITORS: Not recommended.
USE WITH WEAK CYP450 3A4 INHIBITORS: Up to 5 mg orally once a day immediately prior to bedtime
- Maximum dose: 5 mg/day
USE WITH STRONG OR MODERATE CYP450 3A4 INDUCERS: Not recommended.
CONTRAINDICATIONS: Patients with narcolepsy
Safety and efficacy have not been established in children.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule IV
Data not available
- Take immediately before going to bed.
- Dose should be taken with at least 7 hours remaining before the planned time of awakening.
- Time to sleep onset may be delayed if taken with or soon after a meal.
- Store at 20C to 25C.
- Read the approved patient labeling.
- Take only when preparing for or getting into bed and only if you can stay in bed for a full night (at least 7 hours) before being active again.
- The effect of this drug may be delayed if taken with or soon after a meal.
- This drug can impair daytime wakefulness even when used as prescribed. The risk of daytime impairment increases if you do not have a full night of sleep.
- Use caution if you are driving and doing activities requiring complete mental alertness.
- Increased drowsiness may increase your risk of falling.
- This drug may cause complex sleep behaviors, including sleepwalking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Discontinue and notify your healthcare provider immediately if you develop any of these symptoms.
- Report any worsening of depression or suicidal thoughts immediately.
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug. Talk to your doctor if you are pregnant.
- Do not consume alcohol while taking this drug.
- Tell your doctor all your medical conditions, and all the other drugs you are taking, with or without a prescription.
- Do not increase the prescribed dose of this drug and inform your doctor if you think the drug "does not work".
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- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
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