Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders Read More

Inclusion Criteria:

• Male or female above 18 or below 65 years old
• Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
• Written informed consent

Exclusion Criteria:

• Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months

• Patient who has an history of psychiatric diseases, such as:

  • anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be < 10
  • depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be < 10
  • mania
  • schizophrenia
  • dementia

• Patient who has an history of neurologic diseases, such as:

  • Parkinson syndrome
  • crania cerebral trauma post syndrome
  • brain tumor
  • fibromyalgia
• Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
• Patient with an hypersomnia or a sleep apnea syndrome
• Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea
• Patient with a Restless Leg Syndrome
• Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial
• Breast feeding or pregnant female, or female with no efficient contraception method
• Patient with non-stabilised thyroid dysfunction
• Patient with a known allergy to Eschscholtzia Californica or its compounds
• Patient with alcohol or drug dependency
• Patient drinking tea, coffee or Coca-Cola after 4 p.m.