INTERMEZZO- zolpidem tartrate tablet
Purdue Pharma LP
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of INTERMEZZO. Some of these events may result in serious injuries, including death. Discontinue INTERMEZZO immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)].
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.
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)].
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)].
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)].
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)].
INTERMEZZO is contraindicated in patients who have experienced complex sleep behaviors after taking INTERMEZZO [see Warnings and Precautions (5.1)].
INTERMEZZO is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.4)].
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem. Serious injuries and death have occurred during a complex sleep behavior episode. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7.1)] and may occur on first use of zolpidem. Patients who have experienced complex sleep behaviors after taking INTERMEZZO may experience a complex sleep behavior resulting in serious injuries or death after taking a subsequent dose of INTERMEZZO [see Contraindications (4)].Discontinue INTERMEZZO immediately if a patient experiences a complex sleep behavior.
INTERMEZZO, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of INTERMEZZO and of other concomitant CNS depressants may be necessary when INTERMEZZO is administered with such agents because of the 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 Dosage and Administration (2.3)].
In a driving study, healthy subjects who received INTERMEZZO with fewer than four hours of bedtime remaining had evidence of impaired driving compared to subjects who received placebo [see Clinical Studies (14.2)]. The risk of next-day driving impairment (and psychomotor impairment) is increased if INTERMEZZO is taken with less than 4 hours of bedtime remaining, if higher than recommended dose is taken, if co-administered with other CNS depressants, or co-administered with other drugs that increase the blood levels of zolpidem.
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs, including zolpidem.
Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema or anaphylaxis after treatment with zolpidem should not be rechallenged with INTERMEZZO.
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