PEP Topic 
Sleep-Wake Disturbances

Trazodone is an antidepressant drug that is believed to act by inhibiting serotonin and norepinephrine reuptake. It is approved for use in major depression and has been used off-label for other symptoms, such as panic disorder.

Effectiveness Not Established

Research Evidence Summaries

Tanimukai, H., Murai, T., Okazaki, N., Matsuda, Y., Okamoto, Y., Kabeshita, Y., . . . Tsuneto, S. (2013). An observational study of insomnia and nightmare treated with trazodone in patients with advanced cancer. The American Journal of Hospice and Palliative Care, 30, 359–362.

doi: 10.1177/1049909112452334

Study Purpose:

To evaluate trazodone for the treatment of insomnia in patients with cancer.

Intervention Characteristics/Basic Study Process:

Patients were given trazodone 12.5 to 50 mg orally as needed for insomnia.

Sample Characteristics:

  • The sample comprised 30 patients (40% male, 60% female).      
  • Median age was 62 years (range 37–84).
  • Patients had cancer and were experiencing insomnia that had not responded well to standard hypnotics.
  • Diagnoses included gynecological, urological, breast, hepatobiliary-pancreatic, lung, colorectal, lymphoma, other cancers. 
  • Patients were seeking palliative care consultations.


  • Single site  
  • University Hospital in Japan

Phase of Care and Clinical Applications:

  • Patients were undergoing the end of life care phase of care.
  • The study has clinical applicability for palliative care.

Study Design:

The study was an observational, retrospective review.

Measurement Instruments/Methods:

Chart review looking for requests for additional request for hypnotics within seven days of initiation of the intervention


Of the patients with cancer treated with trazodone, 50% did not request additional hypnotics within seven days. Two of four patients reported improved nightmares.


Low-dose trazodone (12.5–50 mg) may be useful in treating insomnia with and without nightmares in patients with cancer.


  • The study had a small sample size, with less than 30 patients.       
  • Baseline sample/group differences were of import.
  • The study had risks of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
  • Unintended interventions or applicable interventions not described would have influenced the results.
  • Measurement/methods were not well described.
  • Measurement validity/reliability was questionable.
  • Findings were not generalizable.
  • This was an observational study only.

Nursing Implications:

Low-dose trazodone may be helpful in treating insomnia and improving nightmares in patients with cancer and insomnia. Further prospective studies are warranted.