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  • Br J Gen Pract · Jan 2025

    Effectiveness of low-dose amitriptyline and mirtazapine in patients with insomnia disorder with sleep maintenance problems: a randomised, double-blind, placebo-controlled trial in general practice (DREAMING).

    • Mette Bakker, Jacqueline G Hugtenburg, Pierre M Bet, TwiskJos W RJWRAmsterdam Public Health Research Institute, Amsterdam, Netherlands.Amsterdam UMC Locatie De Boelelaan, Vrije Universiteit, Department of Epidemiology and Data Science, Amsterdam, Netherlands., Henriëtte van der Horst, and Pauline Slottje.
    • Amsterdam UMC Locatie Meibergdreef, Vrije Universiteit, Department of General Practice, Amsterdam, Netherlands.
    • Br J Gen Pract. 2025 Jan 15.

    BackgroundLow-dose amitriptyline and mirtazapine are widely prescribed off-label for insomnia disorder. However, evidence from placebo-controlled studies is lacking.AimTo assess the effectiveness of low-dose mirtazapine and amitriptyline in patients with insomnia disorder.Design And SettingPragmatic, double-blind, randomised, placebo-controlled trial in general practice.MethodsPatients (18-85 years) with insomnia disorder with sleep maintenance problems for whom non-pharmacological treatment was insufficient were randomised to either mirtazapine (7.5-15 mg/day) or amitriptyline (10-20 mg/day) or placebo for 16 weeks (optional double dose regime in week 3-14).Primary OutcomeInsomnia Severity Index (ISI) total score at week 6 (range 0-28, assessed at baseline, 6, 12, 20 and 52 weeks), clinically relevant 'improvement' (>7 points lower than baseline) and 'recovery' (total score ≤10).Results80 participants were included. At 6 weeks, in the intention-to-treat analyses, mirtazapine and amitriptyline led to statistically significantly lower ISI scores compared to placebo (mean difference -6.0 points, 95% confidence interval -9.0 to -3.1; and -3.4 points, -6.3 to -0.4, respectively). From 12 weeks onwards no statistically significant differences in ISI scores were observed. Mirtazapine, but not amitriptyline, resulted in statistically significantly higher improvement and recovery rates compared to placebo at week 6 (52 and 40 compared to 14%, 56 and 36 compared to 14% respectively).ConclusionCompared to placebo low-dose mirtazapine provided a statistically significant and clinically relevant reduction of insomnia severity at 6 weeks, but not at later time points. Low-dose amitriptyline resulted in a statistically significant reduction at 6 weeks only which was not clinically relevant.Copyright © 2024, The Authors.

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