These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling. Drug Details Company Name Business Partner Drug Name Generic Name Unique ID Studied Indications or Disease Phase Approved Drug Label Astellas Pharma Inc. sanofi-aventis Myslee; (not yet determined for new product) Zolpidem; Zolpidem MR (FK199B) 6199-CL-0006 Insomnia Phase III Label for Myslee: http://www.info.pmda.go.jp/go/pack/1129009F1025_3_09/; Zolpidem MR is not an approved product, therefore no label is available Clinical Study Summary FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients with Insomnia, Excluding Patients with Schizophrenia or Manic-Depressive Psychosis - The content of this posting should not be construed as medical advice. Patients should consult their health care professional for advice on their specific situation. Astellas makes good faith efforts to include accurate and up to date information in its postings. However, because the status of studies often changes, Astellas makes no warranties or representations of any kind as to the currency or completeness of the information contained herein. Astellas further disclaims all warranties express or implied, including warranties of merchantability and fitness for a particular purpose. Astellas shall not be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of, or inability to use information posted by Astellas herein, or any errors or omissions in the content thereof. Accordingly, access to and/or use of information posted on this website is at the user’s own risk. Nothing in Astellas’ posting is intended to be viewed as any claim for any particular marketed or unmarketed product. Some clinical studies may include information not contained in the approved product package insert. Before prescribing any product mentioned in this posting, healthcare professionals should refer to the full prescribing information approved for that product in their country. Company Study 6199-CL-0006 Summary Back to Search Results