Scientific Research: Understanding Relaxium® Sleep Aid

RELAXIUM® Sleep is the Only Drug-Free Sleep Aid Developed by a
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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.
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RESULTS

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  • 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.