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

ABSTRACT:

Study objectives

In a randomized controlled non-inferiority trial, we aimed to determine whether low-dose amitriptyline, which is often used off-label, is a safe and effective alternative to cognitive behavioral therapy for insomnia 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 amitriptyline, 10-20 mg (n = 93), or (2) 12 weeks of group cognitive behavioral therapy for insomnia, seven sessions (n = 94). Assessments took place at baseline, 6 and 12 weeks after start of treatment. The primary non-inferiority outcome was insomnia severity (Insomnia Severity Index) at 12 weeks.

Results

Based on a non-inferiority m

SUBMITTER: Rauwerda N 

PROVIDER: S-EPMC12696364 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature