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 (e.g. Sensoril^® ashwagandha, Valerest^®, a blend of hops and valerian, Chamomile Passionflower).
• Formulation is proprietary
• Sponsor wanted to provide clinical evidence that Relaxium^® Sleep is a bonafide sleep aid

STUDY OBJECTIVES

PRIMARY OBJECTIVE

• To investigate the effect of Relaxium^® Sleep administered prior to bedtime on sleep parameters, compared to placebo, in subjects with insomnia.

SECONDARY OBJECTIVE

• 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