Applies to the following strength(s): 8 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Insomnia
8 mg orally within 30 minutes of going to bed
Maximum Dose: 8 mg per day
Comments: This drug should not be taken with or immediately after a high-fat meal.
Use: Treatment of insomnia characterized by difficulty with sleep onset
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
-Mild Hepatic Impairment (Child-Pugh A): Data not available.
-Moderate Hepatic Impairment (Child-Pugh B): Use with caution.
-Severe Hepatic Impairment (Child-Pugh C): Not recommended.
-Concomitant Use of CYP450 1A2 Inhibiting Drugs: Contraindicated with fluvoxamine; Caution recommended if used with other CYP450 1A2 inhibitors.
-Patients with Severe Sleep Apnea: Not recommended.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
-Hemodialysis: No adjustment recommended.
-Peritoneal dialysis: Data not available.
-The drug tablet should be swallowed whole; tablets should not be broken.
-The container should be kept tightly closed to protect from moisture and humidity.
-This drug does not appear to produce physical dependence; treatment discontinuation after chronic administration did not produce withdrawal signs in humans or in animals.
-If overdosage occurs, general symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate and IV fluids as needed.
-Do not drink alcohol while taking this drug.
-Do not take other medications that can make you sleepy while taking this drug.
-Do not take this drug with food or right after a meal.
-Do not take this drug unless you are able to get a full night's sleep before you must be active again.
-After taking this drug, avoid driving and other activities that require concentration such as operating machinery; limit your activities to those necessary to prepare for bed.
-Consult your healthcare provider if your insomnia worsens or is not better within 7 to 10 days.
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- Other brands: Rozerem