Transcept Pharmaceuticals Comments On New FDA Dosage Reduction Requirements For Zolpidem Based Prescription Sleep Aids Administered At Bedtime
FDA-mandated zolpidem dosage reduction for bedtime products such as Ambien (5 mg and 10 mg tablets) and Ambien CR (6.25 mg and 12.5 mg tablets) does not affect IntermezzoÂ® (zolpidem tartrate 1.75 mg and 3.5 mg sublingual tablets) C-IV dosing
POINT RICHMOND, Calif., Jan. 10, 2013 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) – The FDA is requiring that the manufacturers of certain zolpidem based prescription sleep aids such as Ambien® and Ambien CR®, and generic versions of these products, reduce the recommended dose. FDA has informed the manufacturers of these products that the recommended dose of zolpidem at bedtime for women should be lowered from 10 mg to 5 mg for immediate-release products such as Ambien, and from 12.5 mg to 6.25 mg for extended-release products such as Ambien CR. FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products. The full FDA announcement is available on the FDA website. http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm The FDA announcement further states, "The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo's approval in November 2011, the label already recommended a lower dosage for women than for men." The FDA press release concludes, "To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia. Patients who drive or whose activities require full alertness the morning after use of an insomnia drug should discuss the appropriateness of their medicine with their health professional." "We are pleased that this action by FDA confirms the recommended dose of Intermezzo at 3.5 mg in men and 1.75 mg in women for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep, so long as they have at least 4 hours of remaining bedtime," stated Glenn A. Oclassen, President and Chief Executive Officer of Transcept. Intermezzo was developed by Transcept and is the Company's first FDA approved product. Intermezzo is being marketed in the United States under the terms of a collaboration agreement between Transcept and Purdue Pharmaceutical Products, L.P. Important Safety Information Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.