Zolpidem Dosage

Usual Adult Dose for Insomnia

IMMEDIATE RELEASE (IR) TABLET, ORAL SPRAY, and SUBLINGUAL TABLET (EDLUAR):
-Initial Dose: 5 mg (Women) OR 5 mg or 10 mg (Men)
-Maintenance Dose: The dose may be increased to 10 mg if the 5 mg dose is not effective.
-Maximum Dose: 10 mg once a day.
-Duration of Therapy: The clinical trials in support of efficacy were 4 to 5 weeks in duration.

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLET:
-Initial Dose: 6.25 mg (Women) OR 6.25 mg or 12.5 mg (Men)
-Maintenance Dose: The dose may be increased to 12.5 mg if the 6.25 mg dose is not effective.
-Maximum Dose: 12.5 mg once a day.
-Duration of Therapy: The clinical trials in support of efficacy were up to 3 and 24 weeks in duration.

SUBLINGUAL TABLET (INTERMEZZO):
-Initial and Maximum Dose: 1.75 mg (Women) OR 3.5 mg (Men)

Comments: The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.

Use:
-IR Tablet, Oral Spray, and Sublingual Tablet (Edluar): Short-term treatment of insomnia characterized by difficulties with sleep initiation.
-CR/ER Tablet: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
-Sublingual Tablet (Intermezzo): As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Usual Geriatric Dose for Insomnia

-IMMEDIATE RELEASE TABLET, ORAL SPRAY, and SUBLINGUAL TABLET (EDLUAR): 5 mg
-EXTENDED RELEASE TABLET: 6.25 mg
-SUBLINGUAL TABLET (INTERMEZZO): Men and Women Over the Age of 65 Years: 1.75 mg

Usual Pediatric Dose for Insomnia

Not recommended.

Renal Dose Adjustments

No adjustment recommended; however, closely monitor patients as a general precaution.

Liver Dose Adjustments

IMMEDIATE RELEASE TABLET:
-Mild to Moderate Hepatic Impairment: 5 mg
-Severe Hepatic Impairment: Avoid use.

CONTROLLED/EXTENDED RELEASE TABLET:
-Mild to Moderate Hepatic Impairment: 6.25 mg
-Severe Hepatic Impairment: Avoid use.

ORAL SPRAY and SUBLINGUAL TABLET (EDLUAR):
-Hepatic Impairment: 5 mg

SUBLINGUAL TABLET (INTERMEZZO):
-Men and Women with Hepatic Impairment: 1.75 mg

Dose Adjustments

DEBILITATED PATIENTS:
-Immediate Release (IR) Tablet, Oral Spray, and Sublingual Tablet (Edluar): 5 mg
-Controlled/Extended Release (CR/ER) Tablet: 6.25 mg
-Sublingual Tablet (Intermezzo): Data not available.

CONCOMITANT USE WITH CNS DEPRESSANTS:
-IR Tablet, CR/ER Tablet, Oral Spray, and Sublingual Tablet (Edluar): Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.
-Sublingual Tablet (Intermezzo): Men and Women: 1.75 mg

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

This drug is not dialyzable.

Other Comments

Administration Advice:
-IR Tablet, CR/ER Tablet, Oral Spray, and Sublingual Tablet (Edluar): 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.
-Sublingual Tablet (Intermezzo): 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.
-Prescribe patients the lowest effective dose.
-Advise patients to take this drug as a single dose and not to re-administer during the same night.
-For optimal effect, advise patients not to administer this drug with or immediately after a meal.
-CR/ER Tablet: 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 Tablet (Edluar and Intermezzo): Advise patients to place the tablet under the tongue and allow it to disintegrate completely; this dose form should not be swallowed whole or taken with water.
-Sublingual Tablet (Intermezzo): Advise patients to remove the tablet from the pouch just prior to dosing.

Storage Requirements:
-Consult the manufacturer product information.

General:
-Overdosage: Consult the manufacturer product information for management recommendations.

Monitoring:
-Monitor all patients for tolerance, abuse, and dependence.