VIGISLEEP

                                                                                

THE CONDITION

Sleep disorders can reach as much as one fourth of adult population in western countries. Within sleep disorders subtypes, shift-work sleep disorder is the result of dyssynchrony between the internal clock and the external light-dark cycle.

 

According to surveys in European countries, the USA and also in developing countries, approximately 20% of employees are working in alternating shifts, and may suffer from shift-work sleep disorder.

 

The most troublesome sleep-related symptoms suffered by shift workers include:

 

    • difficulties of initiating sleep
    • shortened sleep
    • impaired sleep quality
    • somnolence during working hours

  

Many patients seek medical support because of daytime consequences of this condition. The most common pharmacological treatments for sleep disorders can provoke undesirable side effects, such as drowsiness and hangover the next day, as well as tolerance and dependence. There is an increasing need for more natural treatments to help people cope with this condition, while avoiding as much as possible the negative impact of pharmacological intervention.

 

PRODUCT PROFILE

VIGISLEEP® is a biphasic food supplement aiming to address difficulties of initiating sleep and somnolence during working hours.

 

The product is presented in a special dual packaging that facilitates patient compliance.  

 

VIGISLEEP® efficacy has been assessed in a clinical trial using the Insomnia Severity Index (ISI) at days 1, 30 and 60. The improvement in insomnia severity was observed after 30 days of treatment.  On average, patients’ condition improved from clinical to subclinical insomnia.

Moreover, the results of different ISI items showed a significant decrease in parameters that might have an important impact in quality of life: 

    • difficulty falling asleep
    • difficulty staying asleep
    • interference with daytime functioning        

Ingredients that are part of VIGISLEEP® composition have obtained health claims by the EFSA (European Food Safety Agency).

DOSAGE FORMS

The pharmaceutical form of VIGISLEEP® is a capsule to be taken 30 minutes before sleep and a capsule to be taken upon awakening.  The capsules used in VIGISLEEP® formulation present the following benefits:

    • rapid onset of action
    • facilitating oral absorption of lipophilic compounds
    • concealment of unpleasant tastes and odour

            

REGULATORY STATUS

 

 

VIGISLEEP® was approved in Europe as a dietary supplement on May 2014 for the first time.