(67) Off-Label Low Dose Amitriptyline for Insomnia Disorder: Patient-Reported Outcomes

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 398

Presenting Author(s)

Jacqueline G. Hugtenburg
– VU University Medical Center Amsterdam, Amsterdam, Netherlands

Co-Author(s)

Mette H. Bakker
– Amsterdam University Medical Centers, Amsterdam, Netherlands
Marcel Smits
– Gelderse Vallei Hospital, Ede, Netherlands
Henriette Van der Horst
– Amsterdam UMC, Netherlands
Pauline Slottje
– Amsterdam UMC, Netherlands

Background: Low dose amitriptyline is prescribed off-label to improve sleep maintenance in patients with insomnia disorder. This off-label prescription exposes patients to potential risks without evidence of the benefit. Data on treatment outcomes are limited.

Objectives: To assess patient-reported treatment effect and side effects of low dose amitriptyline for insomnia in routine care data.

Methods: Cross-sectional study. 752 consecutive patients with insomnia disorder having sleep maintenance problems were treated in an outpatient Sleep Clinic with low dose amitriptyline (10-20 mg based on self-titration). Treatment was intended to improve sleep maintenance. Before the planned follow-up consultation (around 6 weeks since start treatment) patients completed an online treatment evaluation questionnaire. Treatment (dose, adherence), sleep, fatigue, satisfaction and side effects were assessed by multiple-choice questions with room for free-text elaboration.

Results: 53.7% of the patients reported to use amitriptyline up to 10 mg/day, 42.9% used a self-increased dose of mostly 20 mg/day, while 3.5% had discontinued treatment. 73.9 % of the total study population reported improvement of sleep maintenance, 31.3% improved sleep onset, 35.2% improved daytime fatigue, and 45.8% reported to be (very) satisfied with treatment results. 66.1% reported at least one side effect. The reported side effects were generally the already known side-effects of amitriptyline.

Conclusions: These patient-reported outcomes support the clinical observations that low dose amitriptyline improves sleep maintenance on the short term and that it is generally well tolerated. To assess the effectiveness and safety of low dose amitriptyline in patients with insomnia disorder with sleep maintenance problems on the short and long term, we presently are conducting a randomized placebo-controlled trial (the DREAMING study, trial registration number: NTR7449).