Summary of findings 3. 'Other' antidepressants compared with placebo for insomnia.
| 'Other' antidepressants compared with placebo for insomnia | ||||||
| Patient or population: adults with insomnia Setting: outpatients Intervention: other antidepressants (trazodone 25‐150 mg) Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with "other antidepressant" | |||||
| Subjective measure of sleep quality (PSQI, visual analogue scale or subjective rating of sleep at 6 months or 2 weeks or 7 days) | ‐ | The mean subjective measure of sleep quality in the intervention group was 0.34 standard deviations lower in the intervention group (0.02 to 0.66 standard deviations lower) | ‐ | 370 (3 RCTs) | ⊕⊕⊕⊝ Moderate1 | These results show improved subjective sleep quality for other antidepressants and placebo indicating a small effect size. |
| Adverse events | ‐ | ‐ | ‐ | 217 (2 RCTs) |
⊕⊕⊝⊝ Low1,2 | Combining results was not possible. 1 paper (n = 201) reported that 2 placebo‐treated and 5 trazodone‐treated participants withdrew due to adverse events (excessive sleepiness, dizziness, headache, vomiting and mild elevation of blood pressure) and that the trazodone group (65.4%) reported significantly more adverse effects at 2 weeks than the placebo group (75%) (P = 0.003). Another paper (n = 16) reported hangovers (n = 5) and dizziness (n = 2) in the trazodone group compared to hangovers (n = 1), headache (n = 2) and skin irritation (n = 1) in the placebo group. |
| PSG sleep outcomes: sleep efficiency (at 1 week and 4 weeks | The mean sleep efficiency in the placebo group ranged from 81.7% to 85.3 % | The mean sleep efficiency in the TCA group was 1.38 percentage points higher (2.87 lower to 5.67 higher) | ‐ | 169 (2 RCTs) | ⊕⊕⊝⊝ Low1,2 | Results showed no significant difference in sleep efficiency between other antidepressants and placebo. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; n: number of participants; PSG: polysomnography; PSQI: Pittsburgh Sleep Quality Index; RCT: randomised controlled trial; TCA: tricyclic antidepressant | ||||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded one level for unclear risk of bias; lack of information on randomisation, allocation concealment and blinding in included studies.
2Downgraded one level for imprecision; very wide confidence intervals, small numbers or both.