Low dose amitriptyline versus cognitive behavioral therapy for insomnia in patients with medical comorbidity: results of a randomized controlled multicenter non inferiority trial.

Study Objectives: In a randomized controlled non-inferiority trial, we aimed to determine whether low dose Amitriptyline (AM), which is often used off-label, is a safe and effective alternative to cognitive behavioral therapy for insomnia (CBT-I) in the treatment of insomnia among patients with insomnia and medical comorbidity.

Methods: A total of 187 participants with insomnia and medical comorbidity were randomly allocated to either: 1) 12 weeks of AM, 10-20 mg (n = 93), or 2) 12 weeks of group CBT-I, 7 sessions (n = 94). Assessments took place at baseline, 6 and 12 weeks after start of treatment.

TIMELAPSE study-efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial.

Background: Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions.