Tools for Practice

#302 Still awake? Trazodone for insomnia

Is trazodone effective and safe for insomnia?

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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  • 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
  • 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

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  • Adrienne J Lindblad BSP ACPR PharmD
  • Jennifer Potter MD CCFP

1. Everitt H, Baldwin DS, Stuart B, et al. Cochrane Database System Rev. 2018; 5:CD010753.

2. Yi XY, Ni SF, Ghadami MR, et al. Sleep Med. 2018; 45:25-32.

3. Thapa PB, Gideon P, Cost TW, et al. New Engl J Med. 1998; 339:875-82.

4. Coupland C, Dhiman P, Morriss R, et al. BMJ. 2011; 343:d4551.

5. Watt JA, Gomes T, Bronskill SE, et al. CMAJ. 2018 Nov 26; 190:E1376-83.

6. Bronskill SE, Campitelli MA, Iaboni A, et al. J Am Geriatr Soc. 2018; 66:1963-71.

7. Woolcott JC, Richardson KJ, O’Wiens M, et al. Arch Intern Med. 2009; 169(21):1952-60.

8. Seppala LJ, Wermelink AMAT, de Vries M, et al. J Am Med Dir Assoc. 2018; 19(4):372.e1-372.e8

9. Mysliwiec V, Martin JL, Ulmer CS, et al. Ann Intern Med. 2020; 172:325-36.

10. Sateia MJ, Buysse DJ, Krystal AD, et al. J Clin Sleep Med. 2017; 13(2):307-49.

11. Allan GM, Lindblad AJ, Varughese J. Can Fam Physician. 2017; 63(8):613.

Authors do not have any conflicts of interest to declare.