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

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^® 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

Click here to view the Relaxium^® Sleep Clinical Trial

Click here to view the Relaxium^® Sleep Clinical Trial – Full Study

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.