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Intermezzo

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Intermezzo

Intermezzo

INDICATIONS

Intermezzo® (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Limitations of Use

Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.

DOSAGE AND ADMINISTRATION

Important Administration Instructions

Intermezzo is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Intermezzo should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking [see WARNINGS AND PRECAUTIONS].

Intermezzo should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Intermezzo should not be administered with or immediately after a meal. The blister should be removed from the pouch just prior to dosing.

Basic Dosing Information

The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men [see Use In Specific Populations].

Use with CNS Depressants

The recommended Intermezzo dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with Intermezzo because of potentially additive effects. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see WARNINGS AND PRECAUTIONS].

Use in Geriatric Patients

Geriatric patients may be especially sensitive to the effects of zolpidem. The recommended dose of Intermezzo in men and women over 65 years old is 1.75 mg, taken only once per night if needed [see Use In Specific Populations].

Use in Patients with Hepatic Impairment

The recommended dose of Intermezzo in patients with hepatic impairment is 1.75 mg, taken only once per night if needed [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms and Strengths

Intermezzo is available as 1.75 mg and 3.5 mg tablets for sublingual administration.

Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side.

Intermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side.

Each sublingual tablet is individually packaged in a foil blister inside a unit-dose pouch.

Intermezzo 1.75 mg tablets are yellow, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:

NDC Number Size
67213-175-01 Unit-dose pouch containing a sublingual tablet in a foil blister
67213-175-31 Carton of 30 unit-dose pouches

Intermezzo 3.5 mg tablets are beige, round, uncoated, biconvex, debossed with ZZ on one side and supplied as:

NDC Number Size
67213-350-01 Unit-dose pouch containing a sublingual tablet in a foil blister
67213-350-31 Carton of 30 unit-dose pouches

Storage and Handling

Store between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

The patient should be instructed not to remove the blister from the unit-dose pouch until the patient is ready to consume the sublingual tablet inside.

Manufactured for Transcept Pharmaceuticals, Inc. Point Richmond, CA 94804.

Last reviewed on RxList: 12/5/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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