Pharmacological Treatment of Insomnia in Palliative Care

Exclusion Criteria

• •1. On-going treatment or previous treatment (within last 4 weeks) for more than consecutive 3 days with medications given for insomnia
• •2. Adverse reactions to zopiclone
• •3. History of substance abuse
• •4. Concomitant use of rifampicin and erythromycin
• •5. Any other contraindication listed on the summary of product characteristics of the investigated medicinal product:
• •1. Myasthenia gravis
• •2. An established diagnosis of Severe impairment of respiratory function
• •3. An established diagnosis of Severe hepatic insufficiency.(Child-Pugh grade B or C)
• •4. An established diagnosis of sleep apnea
• •5. Known hypersensitivity to the drug or to any component in its formulation: Lactose monohydrate, Calcium hydrogen phosphate, Maize starch, Croscarmellose sodium, Magnesium stearate, Titanium dioxide (E 171), Hypromellose, Iron oxide yellow/Iron oxide red (E 172) and Macrogol
• •6. Unfit for participation for any reason as judged by the investigator
• •7. Pregnancy or lactation
• •8. Women of reproductive age not willing or unable to employ an effective method of contraception (sterilization, using IUD or oral contraception)
• •9. Scheduled surgery within the next week
• •10. In the need of change in scheduled opioid dose at baseline (study visit 1)
• •11. Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week
• •12. Change in corticosteroid dose last week before baseline or planned dose change in corticosteroid dose within 7 days from baseline