Mirtazapine for chronic insomnia in older adults: a randomised double-blind placebo-controlled trial—the MIRAGE study
Bibliographic record
Abstract
BACKGROUND: Mirtazapine promotes sleep by blocking serotonin and histaminergic receptors and is often used off-label to treat chronic insomnia. However, its efficacy remains to be demonstrated in a clinical trial. The MIRAGE study aims to determine the efficacy and safety of mirtazapine in older patients with chronic insomnia. METHODS: This was a double-blind, randomised, placebo-controlled trial in a geriatric outpatient clinic of a teaching hospital. Adults aged 65 years and older with chronic insomnia were included. Sixty participants were randomised in a 1:1 ratio to receive mirtazapine 7.5 mg or a matching placebo for 28 days. The primary efficacy endpoint was the mean change in the Insomnia Severity Index (ISI) score from baseline to 28 days post-treatment. The primary safety endpoints included any adverse events reported during the clinical trial and all adverse events leading to premature discontinuation. RESULTS: Mirtazapine was superior to placebo on the primary outcome measure, subjective wake after sleep onset, total sleep time and sleep efficiency. After 28 days, the mean change in ISI score was significantly greater in the mirtazapine group (-6.5 [95%CI; -8.3 to -4.8]) compared to the placebo group (-2.9 [95%CI; -4.4 to -1.4]), with a p-value of 0.003. No participant experienced severe adverse events. A total of 6 participants in the mirtazapine group and 1 participant in the placebo group discontinued their treatment due to adverse events. CONCLUSION: Mirtazapine reduces chronic insomnia symptoms in older people. However, its use may be limited by mild but clinically relevant adverse events. (clinicaltrials.gov NCT05247697). IMPACT STATEMENT: This is the first randomised, double-blind, placebo-controlled trial on the efficacy and safety of Mirtazapine in older adults with chronic insomnia. Our findings show that a 28-day treatment with mirtazapine, compared to placebo, significantly reduces insomnia severity, as measured by the Insomnia Severity Index. Despite the current lack of robust evidence, mirtazapine is widely prescribed by clinicians to treat insomnia in older adults with chronic insomnia. Publishing our study will facilitate the broad dissemination of this critical information, helping clinicians more effectively treat their older patients.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".