Scientific Research: Understanding Relaxium® Sleep Aid

BACKGROUND

• Relaxium® Sleep: 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 such as Valerian® (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 sleep issues.
2. To assess the safety and tolerability of Relaxium® Sleep.

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® Sleep 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

• Compared to Placebo, Relaxium® Sleep was Associated with Statistically Significant Findings:
  • Fall Asleep Faster
  • Sleep Longer Without Interruption
  • Wake Refreshed and Alert
  • Improve Concentration

SAFETY

• No adverse events were reported in the study.