Neurocrine Biosciences reports positive insomnia data

Data also showed there was no evidence of tolerance over the three-month treatment period or withdrawal upon discontinuation of treatment – complications often seen with extended use of older-generation sleep medications.

The primary endpoint for the clinical study was latency to sleep onset (LSO) or the time it takes patients to fall asleep, as reported by patients. Data showed that indiplon capsules resulted in significant and sustained improvements in LSO and provided patients with 50% improvement in LSO from baseline.

The mean improvement from baseline LSO for the indiplon treatment groups was as high as 27.2 minutes for the 10mg group and 27.6 minutes for the 20mg group compared to a maximum of 18 minutes for the placebo group over the three-month dosing period.

The study also assessed several subjective secondary endpoints including total sleep time (sTST). Results showed that indiplon capsules resulted in significant improvements in sTST, with patients gaining approximately one hour more of sleep during the night.

The results also showed that indiplon significantly reduced the amount of time patients spent awake in the middle of the night and patients reported a statistically significant improvement in overall sleep quality.

“This study demonstrates the ability of indiplon to help patients not only fall asleep but maintain sleep throughout the night and shows the effectiveness of indiplon capsules in treating the varying sleep needs of patients with insomnia,” said Dr Martin Scharf of the Tri-State Sleep Disorders Center. “Importantly, this study shows that indiplon can be given over long periods of time without inducing tolerance, a key concern to physicians treating patients with chronic insomnia.”