Pharmacology
Indiplon Shows Significant Benefits in Chronic Insomnia
By Neurocrine Biosciences
May 27, 2005, 17:36

Neurocrine Biosciences, Inc. announced that data presented at the 2005 American Psychiatric Association (APA) Annual Meeting showed that nightly administration of indiplon capsules resulted in significant and sustained improvement in sleep onset and sleep maintenance in patients with chronic insomnia over the entire treatment period.

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

"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. Furthermore, indiplon was shown to be safe and effective without next-day residual effects for long-term treatment of chronic insomnia."

The study, which was conducted in 67 centers worldwide, was a randomized, double blind, placebo-controlled trial evaluating the safety, efficacy, and tolerability of indiplon capsules in 702 patients with moderate to severe chronic insomnia. Patients were randomized to three months of treatment with either indiplon 10 mg or 20 mg capsules, or placebo.

Patients Consistently Fell Asleep Faster With Indiplon

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 (p less than 0.0001 to p less than 0.0004) 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.

Patients Gained an Hour of Sleep and Slept Through the Night

The study also assessed several subjective secondary endpoints including Total Sleep Time (sTST), Wake After Sleep Onset (sWASO) and Number of Awakenings after Sleep Onset (sNAASO) which are used to assess sleep maintenance effects. Results showed that indiplon capsules resulted in significant improvements in sTST (all p<0<0<0

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