Insomnia therapy produced more clinical responders than amitriptyline
Among people with insomnia and other medical conditions, therapy produced more clinical responders. Amitriptyline met the trial's non-inferiority threshold but caused more side effects.
Based on the published abstract. The full paper may contain additional methods, results and limitations.
The 30-second takeaway
Amitriptyline met the trial's permitted margin for insomnia symptom severity, but more participants receiving therapy achieved a clinically meaningful response. Participants taking the drug also reported more side effects. These results show why meeting a non-inferiority threshold does not establish equivalent overall outcomes for people with insomnia and other medical conditions.
The authors called the permitted margin liberal. Abstract-only access leaves the timing and persistence of sleep worsening after discontinuation unclear.
What researchers found
Participants achieving clinical response
Therapy versus amitriptyline after 12 weeks: improvement of at least 8 Insomnia Severity Index points; p = .02.
What the threshold means
The trial allowed amitriptyline to be up to 4 points worse on the insomnia symptom scale. Meeting this non-inferiority criterion answers a different question from whether the treatments produce equivalent overall outcomes.
Sleep after stopping treatment
After stopping amitriptyline, 68 per cent of its participants reported worse sleep. Some worsening was described as temporary, but the abstract does not specify the timing of these assessments or how long symptoms persisted.
The original publication
Low-dose amitriptyline versus cognitive behavioral therapy for insomnia in patients with medical comorbidity: results of a randomized controlled multicenter non-inferiority trial.
Rauwerda N, van Straten A, Zondervan A et al.
Sleep · 2025
- PubMed ID
- 40569003
- Record checked
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