Trial Information

Summary: Do you have Insomnia? Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study

Do you have problems staying asleep at night, and is it interfereing with your day to day life? We are conducting a study on a new medication to help with your sleep quality. This study takes 12 weeks, you will keep an electronic diary of your sleep schedule. Investigational medicine and study related healthcare will be provided free of charge. You will be compensated for your time and travel.

• Patients aged = 18 years
• Diagnosis of primary insomnia based on criteria with predominant complaints of difficulty maintaining sleep (nocturnal awakenings or early morning awakening) for at least one month preceding the study visit, and having clinically significant distress or impairment in social occupational or other important areas of functioning.
• Patients must report impact daytime functioning associated with sleep maintenance insomnia

Exclusion Criteria:

• Females who are lactating or who are pregnant.
• Night shift workers, and individuals who nap 3 or more times per week over the preceding month.
• Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) of more than 5 cups or glasses per day.
• Use of any over-the-counter medicine for sleep including tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication, within one week prior to screening.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.