#302 Still awake? Trazodone for insomnia

CLINICAL QUESTION

QUESTION CLINIQUE

Is trazodone effective and safe for insomnia?

BOTTOM LINE

RÉSULTAT FINAL

Besides a “small” effect on short-term sleep quality and perhaps 0.3 less awakenings per night, trazodone does not have consistent benefits on sleep over placebo. There is no evidence that trazodone results in fewer falls than other sedative-hypnotics.

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EVIDENCE

DONNÉES PROBANTES

Results statistically different unless specified.
Efficacy:
- Trazodone versus placebo: most recent systematic review, 7 randomized, placebo-controlled trials (RCTs) of trazodone (ages 18-75, 16-306 participants, dose 50-200mg for 1-12 weeks).¹
  - Time to fall asleep: No difference.
  - Number of awakenings: 0.31 fewer.
  - Sleep quality: Standard mean difference=0.34 at 7 days to 6 months over placebo (clinical meaning unclear) (3 RCTs). No difference at 6 months (1 RCT).
  - Other outcomes inconsistent. Examples:
    - Total sleep time: no difference in 2 RCTs, improved at 6 weeks in 1 RCT.
    - Daytime functioning: no difference or improved depending on RCT.
- Trazodone versus zolpidem: 1 RCT (181 patients) showed no difference in any outcome at 2 weeks but did not use all randomized patients.¹
- Another systematic review with 7 RCTs (including 3 in patients with depression) had similar findings.²
Safety (all retrospective observational studies):
- Falls:
  - Increased risk compared to no antidepressant (2 studies):
    - Trazodone 244 falls versus no antidepressant 131 falls per 100 person-years, borderline statistical significance [adjusted rate ratio=1.2 (1.0 to 1.4)].³
    - Trazodone falls 5.3% versus 3.5% no antidepressant.⁴
  - No difference compared to antipsychotics (1 study).⁵
  - No difference in fall-related emergency or hospital admissions at 90 days versus benzodiazepines (1 study).⁶
- Mortality increased compared to no antidepressant (12% versus 7%).⁴

CONTEXT

All antidepressant classes have been associated with falls/fractures, with similar fall risk to benzodiazepines and z-drugs.^7,8
Guidelines recommend against trazodone for insomnia.^9,10
Sleep restriction therapy can be an effective treatment for insomnia in primary care.¹¹