Post by syedsanaullah on Feb 10, 2013 13:56:11 GMT -5
Full Prescribing Information | Important Safety Information
Intermezzo® (zolpidem tartrate) 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.
FAST ASLEEP.
AWAKE IN THE MIDDLE
OF THE NIGHT.
BACK TO SLEEP WITH
INTERMEZZO.
Dear Pharmacist,
Purdue Pharma L.P. appreciates the important role pharmacists play in the dispensing and proper use of prescription medications. As the liaison between patient and prescription, we want you and your patients to be well informed should questions arise about taking Intermezzo. Intermezzo is the first and only prescription sleep aid approved for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep with at least 4 hours left for sleep.
Important Safety Information
Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
Please read the additional Important Safety Information below.
The first and only prescription sleep aid with the following indication1
There is no AB rated generic equivalent for the two available doses of Intermezzo (1.75 mg and 3.5 mg). No other prescription sleep aid should be substituted for Intermezzo
Intermezzo is the first and only prescription sleep aid approved for
once-nightly, as-needed dosing for middle-of-the-night awakenings
if your patient has at least 4 hours of sleep time left
Dosage and administration
•
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
•
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
Tablets not shown at actual size.
•
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
•
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
•
Geriatric patients may be especially sensitive to the effects of zolpidem
•
The recommended dose of Intermezzo in men and women over 65 years old and patients with hepatic impairment is 1.75 mg, taken only once per night if needed
Ordering information for Intermezzo
Intermezzo shelf-pack specifications
*
WAC represents the list price available to all authorized or eligible classes of trade that purchase directly from Purdue. This price does not include any discounts (including prompt-pay discounts, stocking or distribution allowances, rebates, or chargebacks) available to wholesalers or any other customers.
Intermezzo wholesaler item numbers
Important Safety Information (cont.)
Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.
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. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after taking Intermezzo, such that a potential negative effect on driving cannot be completely excluded.
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.
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. Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking zolpidem and may be fatal. Patients who develop angioedema or anaphylaxis should not be rechallenged.
Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as "sleep-driving" have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a "sleep-driving" episode.
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.
Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.
The most commonly observed adverse reactions (>1%) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).
Please read the Full Prescribing Information and Medication Guide.
Sincerely,
Purdue Pharma L.P.
Reference: 1. Intermezzo Full Prescribing Information. Purdue Pharma L.P.
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