BACKGROUND

• Relaxium^®: a novel formulation of various herbs and known sleep inducers has been developed
• Key ingredients include melatonin, L-tryptophan, gamma-aminobutyric acid (GABA) and several herbal extracts ( Valerest^®, a blend of hops and valerian, ashwagandha, Chamomile and Passionflower)
• Formulation is proprietary
• Sponsor wanted to provide clinical evidence that Relaxium^® Sleep is a bonafide sleep aid

STUDY OBJECTIVES

1. To investigate the effect of Relaxium^® Sleep administered prior to bedtime on sleep parameters, compared to placebo, in subjects with insomnia.
2. To assess the safety and tolerability of Relaxium^®.

STUDY DESIGN

• Double-blind, Randomized, Placebo-controlled Parallel Group Design in subjects with insomnia
• A 1-week lead-in period with placebo capsules was followed by randomization to either placebo or Relaxium^® in Week 2
• All medication was to be taken about 1 hour before bedtime
• Leeds Sleep Evaluation Questionnaires on the last 3-4 days of each treatment week

RESULTS

Click here to view the Relaxium^® Sleep Clinical Trial

• Compared to Placebo, Relaxium^® was Associated with Statistically Significant Findings:
  • Fall Asleep Faster by 140%
  • Sleep Longer Without Interruption by 266%
  • Wake Refreshed and Alert by 69%
  • Improve Concentration by 80%

SAFETY

• No adverse events were reported in the study