The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)

Inclusion Criteria:

• Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
• Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
• Patients able to follow the study protocol
• Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
• Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
• Patients who have just been identified to receive treatment with Circadin
• Patients without previous treatment with Circadin

Exclusion Criteria:

• Hypersensitivity to any components of Circadin
• Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
• Pregnancy and lactation
• Alcohol or drug addiction
• Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
• Intake of psychoactive medicines within the last 30 days before observational study entry
• Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
• Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders