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Transcept Pharmaceuticals Announces National Product Launch Of Intermezzo® By Purdue Pharma L.P.

Each sublingual tablet is individually packaged in a foil blister inside a unit-dose pouch. Before going to bed, a single pouch should be placed by the bedside with a clock or watch nearby. All other unopened Intermezzo pouches should be stored with other medicines away from the bedside. Patients should open the Intermezzo pouch only when they are ready to use it.

Patients can either use the Dosing Time Chart or the Dosing Time Tool that comes with Intermezzo to find the latest time during the night they can take Intermezzo.

Dosing Time Tool: Patients turn a wheel to find the earliest time they must be awake, which corresponds with instructions to take Intermezzo before a specified time.

Dosing Time Chart: The chart helps patients locate the earliest time they need to be awake and match it to the latest time they can take Intermezzo.

When patients wake in the morning, they should make sure that at least four hours have passed since they took Intermezzo and they feel fully awake before driving or engaging in other activities requiring full mental alertness.  Patients should not do dangerous activities until they know how Intermezzo affects them.

Additional Important Safety Information

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 be fatal. Patients who develop angioedema or anaphylaxis should not be re-challenged.

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.

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