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 (5.1)].

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 tablet 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 (8.6)].

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 (5.1)].

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 (8.5)].

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 (12.3)].