Temazepam or Melatonin Versus Placebo for the Treatment of INsomnia in Advanced CAncer: A Three Arm, Double Blind, Phase III, Multicentre, Randomised Clinical Trial

Exclusion Criteria12

• Patient has pain or other unstable symptoms that the clinician and patient feels is directly contributing to poor sleep unless the symptom is optimally treated with no potential to change during the course of the study Patients with unstable symptoms can be re-screened once the symptoms are stable
• Patient who has taken any prescription medication for sleep within 3 days prior to randomisation.
• Patients on prescription medication for sleep can be re-screened once medication has been ceased for 3 or more days
• Concurrent use of benzodiazepines for any indication
• Patient has had more than 2 falls in the past week
• Patients on varying doses of corticosteroids for any reason during the intervention period or 3 days prior to randomisation
• Plan for surgery during the study period
• Formally diagnosed active and uncontrolled alcohol or substance abuse disorder Intolerance to melatonin or temazepam
• Patient is pregnant or lactating
• Unstable psychiatric illness as assessed by the clinician
• Any contraindication listed on the product description for temazepam or melatonin
• The patient is on another clinical trial of an investigational agent that is likely to interfere with sleep