Usual Adult Dose for Insomnia

IMMEDIATE RELEASE (IR) TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations):
Initial dose:

• Women: 5 mg orally once a day immediately prior to bedtime
• Men: 5 to 10 mg orally once a day immediately prior to bedtime

Maintenance dose: 5 to 10 mg orally once a day immediately prior to bedtime
Maximum dose: 10 mg/day

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLETS:
Initial dose:

• Women: 6.25 mg orally once a day immediately prior to bedtime
• Men: 6.25 to 12.5 mg orally once a day immediately prior to bedtime

Maintenance dose: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maximum dose: 12.5 mg/day

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Women: 1.75 mg orally once a day at night as needed

• Maximum dose: 1.75 mg/day

Men: 3.5 mg orally once a day at night as needed

• Maximum dose: 3.5 mg/day

Comments:

• The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.
• Clinical trials supporting IR tablet efficacy were 4 to 5 weeks' duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
• The 1.75 and 3.5 mg sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
• LIMITATION OF USE: The 1.75 and 3.5 mg sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.

Uses:

• IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
• CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
• Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

Usual Geriatric Dose for Insomnia

IR TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations): 5 mg orally once a day immediately prior to bedtime

• Maximum dose: 5 mg/day

CR/ER TABLETS:
Patients 65 years and over: 6.25 mg orally once a day at night immediately prior to bedtime

• Maximum dose: 6.25 mg/day

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Patients over 65 years: 1.75 mg orally once a day at night as needed

• Maximum dose: 1.75 mg/day

Comments:

• Doses are the same in men and women.
• Clinical trials supporting IR tablet efficacy were 4 to 5 weeks' duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
• The 1.75 sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
• LIMITATION OF USE: The 1.75 sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.

Uses:

• IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
• CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
• Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

Renal Dose Adjustments

No adjustment recommended; however, frequent monitoring recommended.

Liver Dose Adjustments

IR TABLETS:

• Mild to Moderate Liver Dysfunction: 5 mg orally once a day immediately prior to bedtime
• Severe Liver Impairment: Not recommended.

CR/ER RELEASE TABLETS:

• Mild to Moderate Liver Dysfunction: 6.25 mg orally once a day at night immediately prior to bedtime
• Maximum dose: 6.25 mg/day
• Severe Liver Dysfunction: Not recommended.

ORAL SPRAY and SUBLINGUAL TABLETS (5 and 10 mg Formulations):
Liver dysfunction: 5 mg orally once a day immediately prior to bedtime

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Liver dysfunction: 1.75 mg orally once a day at night as needed

• Maximum dose: 1.75 mg/day

Dose Adjustments

CONCOMITANT USE WITH CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS:
IR Tablets, CR/ER Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.

Sublingual Tablets (1.75 and 3.5 mg Formulations): 1.75 mg orally once a day at night as needed

• Maximum dose: 1.75 mg/day

DEBILITATED PATIENTS:
IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): 5 mg orally once a day immediately prior to bedtime

• Maximum dose: 5 mg/day

CR/ER Tablets: 6.25 mg orally once a day at night immediately prior to bedtime

• Maximum dose: 6.25 mg/day

Sublingual Tablets (1.75 and 3.5 mg Formulations): Data not available

Comment: Sublingual formulation doses are the same in men and women.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to either active component or to any of the ingredients
• Patients who have experienced complex sleep behaviors after taking this drug

US BOXED WARNINGS:
COMPLEX SLEEP BEHAVIORS:

• Complex sleep behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur following use of this drug.
• Some of these events may result in serious injuries, including death.

Recommendation:

• Discontinue this drug immediately if the patient experiences a complex sleep behavior.

Safety and efficacy have not been established in patients younger than 18 years. This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

This drug is dialyzable; however, no dose adjustment guidelines have been reported.

Other Comments

Administration Advice:

• All Formulations: Patients should avoid administering this drug with or immediately after a meal.
• IR Tablets, CR/ER Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Advise patients to administer this drug orally once a day immediately before or at bedtime with at least 7 to 8 hours remaining before the planned time of awakening.
• IR tablets: Patients should take this drug as a single dose and should avoid readministration during the same night.
• CR/ER tablets: Advise patients to swallow this dose form whole, and not to divide, crush, or chew it.
• Oral Spray: Consult the manufacturer product information for instructions on how to administer this dose form.
• Sublingual Tablets: The tablet should be placed under the tongue and allow it to disintegrate completely; this formulation should not be swallowed whole or taken with water.
• Sublingual Tablets (1.75 and 3.5 mg Formulations): Advise patients to administer this drug orally once a night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep AND with at least 4 hours remaining before the planned time of awakening.
• Sublingual Tablets (1.75 and 3.5 mg Formulations): Advise patients to remove the tablet from the pouch just prior to dosing.

Storage Requirements: The manufacturer product information should be consulted.

General:

• The lowest effective dose should be used for shortest amount of time possible.
• In clinical trials, immediate-release formulations have been shown to decrease sleep latency for up to 35 days.
• LIMITATION OF USE: The 1.75 and 3.5 mg sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.
• Overdosage: Consult the manufacturer product information for management recommendations.

Monitoring:

• NERVOUS SYSTEM: Changes in cognitive function, including complex behaviors
• PSYCHIATRIC: New/worsening depression; signs/symptoms of dependence, tolerance, rebound insomnia, and/or withdrawal
• RESPIRATORY: Respiratory function in patients with compromised respiratory function

Patient advice:

• Patients should be instructed to immediately report "sleep driving," other complex behaviors, and any new/worsening signs/symptoms of depression.
• Inform patients that this drug may cause blurred vision, dizziness, impaired coordination, prolonged reaction time, short-term memory impairment, and/or somnolence, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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