![]() ![]() 5 6Ĭognitive–behavioural therapy for insomnia (CBT-I) is internationally considered the first-choice therapy for insomnia disorder, 7–10 since its long-term effectiveness has been shown to be larger with fewer side effects compared with pharmacological therapy. 3 4 In Europe, the indirect costs for insomnia disorder are being estimated at €1472 per patient per year, mainly because of loss of work productivity. Apart from being difficult to treat, insomnia is associated with various major physical and mental health consequences such as an increased risk of cardiovascular diseases and depression. ![]() 2 Patients may experience difficulty initiating sleep, maintaining sleep and early-morning awakening with inability to return to sleep again. 1 According to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), the diagnosis insomnia disorder is based on the clinical assessment of a predominant complaint of dissatisfaction with sleep quantity or quality for three or more days a week during more than 3 months, resulting in significant daytime impairment despite sufficient opportunity to sleep. Insomnia disorder is a prevalent condition affecting sleep and the daily lives of about 6% of the population. Secondary outcomes include subjective sleep quality quantified by sleep indices, daytime functioning and symptoms, safety and treatment evaluation and other sleep care consumption. The primary study outcome is self-reported insomnia severity at 6 weeks, measured with the Insomnia Severity Index (ISI) in an intention to treat analysis. Questionnaire assessments will be conducted at baseline, week 6, 12, 20 and 52. All participants start and end with single dose, but dose can be doubled following GP consultation in week 3. Participants (n=156) will be randomly assigned to three parallel treatment groups of 16-week treatment with either amitriptyline (one or two tablets of 10 mg/day) or mirtazapine (one or two tablets of 7.5 mg/day) or placebo (one or two tablets) alongside usual GP care. Exclusion criteria: isolated sleep initiation problem, contraindications for or drug–drug interactions with either amitriptyline or mirtazapine. Adults (18–85 years) with insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders-5) who ask their general practitioner (GP) for sleep medication when non-pharmacological treatment is deemed not effective, are eligible. Find out more by booking an exam online or by calling any office to schedule with a team member.The Drug REdiscovery: low-dose Amitriptyline and Mirtazapine for INsomnia disorder in General practice (DREAMING) study is a randomised, double-blind, placebo-controlled trial in about 50 general practices. You can get help for insomnia at Texas Pediatric Specialties and Family Sleep Center. No matter which insomnia treatment is right for you, Texas Pediatric Specialties and Family Sleep Center cares for you every step of the way for as long as you need.
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