Usual Adult Dose for Anxiety

Initial dose: 75 mg orally once a day
Maintenance dose: 75 to 150 mg orally once a day or in divided doses; patients with very mild disease may be adequately controlled with 25 to 50 mg per day
Maximum dose: 150 mg/day

Comments:

• More severely ill patients may require higher doses with a gradual increase to 300 mg/day; additional therapeutic benefit is rarely obtained with doses greater than 300 mg/day.
• Dosages may be increased or decreased following initial dose at appropriate intervals and based on individual patient response.
• The anti-anxiety effect is apparent before the antidepressant effect; may take 2 to 3 weeks for optimal antidepressant effect to be seen.
• The 150 mg capsule is intended for maintenance therapy and should not be used for initiation of treatment.

Uses: For the treatment of psychoneurotic patients with depression and/or anxiety; for the treatment of depression and/or anxiety associated with alcoholism; for the treatment of depression and/or anxiety associated with organic disease; and for the treatment of psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders

Usual Adult Dose for Depression

Initial dose: 75 mg orally once a day
Maintenance dose: 75 to 150 mg orally once a day or in divided doses; patients with very mild disease may be adequately controlled with 25 to 50 mg per day
Maximum dose: 150 mg/day

Comments:

• More severely ill patients may require higher doses with a gradual increase to 300 mg/day; additional therapeutic benefit is rarely obtained with doses greater than 300 mg/day.
• Dosages may be increased or decreased following initial dose at appropriate intervals and based on individual patient response.
• The anti-anxiety effect is apparent before the antidepressant effect; may take 2 to 3 weeks for optimal antidepressant effect to be seen.
• The 150 mg capsule is intended for maintenance therapy and should not be used for initiation of treatment.

Uses: For the treatment of psychoneurotic patients with depression and/or anxiety; for the treatment of depression and/or anxiety associated with alcoholism; for the treatment of depression and/or anxiety associated with organic disease; and for the treatment of psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders

Usual Adult Dose for Insomnia

6 mg orally once a day; 3 mg once a day may be appropriate for some patients
Maximum dose: 6 mg/day

Comments: Dosages should be individualized based on the needs of each patient.

Use: For the treatment of insomnia characterized by difficulty with sleep maintenance; clinical trials in support of efficacy were up to 3 months duration

Usual Geriatric Dose for Insomnia

3 mg orally once a day; may increase to 6 mg/day if clinically indicated
Maximum dose: 6 mg/day

Comments:

• Dosages should be individualized based on the needs of each patient.
• Sleep-promoting drugs may cause confusion and over-sedation in the elderly; a starting dose of 3 mg and evaluation prior to considering dose escalation is recommended.

Use: For the treatment of insomnia characterized by difficulty with sleep maintenance; clinical trials in support of efficacy were up to 3 months duration

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Capsules and Oral Concentrate: Data not available

Tablets: Initiate treatment with 3 mg orally once a day; monitor closely for adverse daytime effects

Dose Adjustments

Sleep Apnea:

• This drug has not been studied in patients with obstructive sleep apnea.

Recommendations:

• Due to the possibility of this drug to depress respiratory drive, precautions should be taken if prescribed to patients with compromised respiratory function.
• Use should be avoided in patients with severe sleep apnea.

Elderly:

• Capsules and Oral Concentrate: Dose selection should be cautious and initiated at the lower end of the dosing range due to increased risk of concomitant hepatic, renal, or cardiac dysfunction.
• This drug meets Beers Criteria; avoid doses of more than 6 mg/day in older adults.

Precautions

US BOXED WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS:

• Antidepressants increased the risk compared to placebo of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
• Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

Recommendations:

• Consider the benefit versus risk of treatment prior to use.
• Monitor patients appropriately and observe closely for clinical worsening, suicidality, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.
• This drug is not approved for use in pediatric patients.

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Avoid the use of alcohol.
• Capsules and Oral Concentrate: Dose may be taken once a day or in divided doses; if taken once a day, it may be given at bedtime.
• Tablets: Take within 30 minutes of bedtime; avoid taking within 3 hours of a meal to minimize potential for next day effects.

Storage requirements:

• Protect from light.

Reconstitution/preparation techniques:

• Oral Concentrate: Dilute with about 120 mL of water, whole or skim milk, or orange, grapefruit, tomato, prune, or pineapple juice.
• Preparation and storage of bulk dilutions not recommended.

General:

• Carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., incrementation of dose, drug seeking behavior).
• The target symptoms of psychoneurosis that respond particularly well to the capsules and oral concentrate include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension, and worry.

Monitoring:

• Psychiatric: Monitor for signs/symptoms of worsening depression, including the occurrence of suicidal thoughts or actions.

Patient advice:

• Report to your physician if you experience an episode of "sleep-driving" or other complex behaviors in which you have no memory of afterwards.
• Talk to your doctor if your depression worsens, including suicidal thoughts and actions.
• Avoid using alcohol while taking this drug.
• Do not abruptly stop this medication without first talking to your physician.
• Refer to the patient medication guide for more information.

Frequently asked questions

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