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Transcept Pharmaceuticals Comments On New FDA Dosage Reduction Requirements For Zolpidem Based Prescription Sleep Aids Administered At Bedtime

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. Prescribe the least amount of Intermezzo that is feasible in these patients.

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.

For additional information, please read the Intermezzo Full Prescribing Information available at http://www.purduepharma.com/IntermezzoPI.

Contact:Transcept Pharmaceuticals, Inc. Greg MannSenior Director, Corporate Communications(510) 215-3567 gmann@transcept.com

SOURCE Transcept Pharmaceuticals, Inc.

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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