Safety and Clinical Data

Clinical Data

Clinical studies using GABAdone® have shown that it can help patients with insomnia fall asleep sooner (reduction in sleep latency), increase the duration of sleep and reduce awakenings. A double-blind placebo controlled study was carried out for GABAdone® in 18 subjects. Nine patients were randomized to GABAdone® (active group) while the rest were randomized to placebo (control group). Study endpoints measured, before and after the administration of GABAdone®, were ability to fall asleep, validated questionnaires reflecting sleep quality, and measurements of autonomic nervous system function using heart rate variability analysis from 24-hour electrocardiograph recordings. As shown in Figure 4, the active group achieved a 43% reduction in sleep latency, as compared to only 5% reduction in the control group. Also, the average number of minutes of morning grogginess was reduced by 64% in the active group patients, while it was reduced by only 4% with placebo

Effect of GABAdone and Placebo on Time to Fall Asleep (Sleep Latency) and on AM Grogginess (Restorative Sleep)

Figure 4: Effect of GABAdone® and Placebo on Time to Fall Asleep (Sleep Latency) and on AM Grogginess (Restorative Sleep)