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