Summary of findings 2. Trazodone compared to placebo for sleep disturbances in dementia.
| Trazodone compared to placebo for sleep disturbances in dementia | ||||||
| Patient or population: sleep disturbances in dementia Setting: community Intervention: trazodone Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with trazodone | |||||
| Total nocturnal sleep time assessed with: actigraphy follow‐up: 2 weeks | The mean total nocturnal sleep time in the placebo group was 281.9 minutes | The total nocturnal sleep time was, on average, 42.5 minutes more in the trazodone group (0.9 more to 84 more) | ‐ | 30 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Nocturnal time awake after sleep onset assessed with: actigraphy follow‐up: 2 weeks | The mean nocturnal time awake after sleep onset in the placebo group was 203.4 minutes | The nocturnal time awake after sleep onset was, on average, 20.41 minutes less in the trazodone group (60.4 less to 19.6 more) | ‐ | 30 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Number of nocturnal awakenings assessed with: actigraphy follow‐up: 2 weeks | The mean number of nocturnal awakenings in the placebo group was 26 | The number of nocturnal awakenings was, on average, 3.71 fewer in the trazodone group (8.2 fewer to 0.8 more) | ‐ | 30 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | |
| Daytime total sleep time assessed with: actigraphy follow‐up: 2 weeks | The mean daytime total sleep time in the placebo group was 144.7 minutes | The daytime total sleep time was, on average, 5.12 minutes more in the trazodone group (28.2 fewer to 38.4 more) | ‐ | 30 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | Ratio of daytime to night‐time sleep not measured in this study. Total daytime sleep time included as an alternative measure of daytime somnolence. |
| Reporting at least one adverse event assessed with: spontaneous patient/carer report follow‐up: 2 weeks | Assumed risk for the placebo group was 40 per 100 |
Comparative risk for the trazodone group was 27 per 100 (9 to 76) |
RR 0.67 (0.23 to 1.89) | 30 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | All adverse events were described as mild. |
| Cognitive function assessed with: MMSE Scale from: 0 (worse) to 30 follow‐up: 2 weeks | The mean MMSE score in the placebo group was 10.5 | The mean MMSE score was, on average, 0.1 higher in the trazodone group (0.9 lower to 1.1 higher) | ‐ | 30 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | Minimum clinically important difference is uncertain, but has been estimated at 1.4 points in moderate‐to‐severe AD (Howard 2011). |
| Caregiver burden ‐ not measured | Not measured | ‐ | ‐ | ‐ | ||
| *The risk in the intervention group (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; RR: Risk ratio; OR: Odds ratio; | ||||||
| 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 | ||||||
1 Single small study
2 95% CI includes no effect and effect likely to be of clinical importance.