A Review of the Evidence for the Efficacy and Safety of Trazodone in Insomnia
J Clin Psychiatry 2005;66(4):469-476
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: Trazodone, a triazolopyridine
antidepressant, is currently the second most commonly prescribed
agent for the treatment of insomnia due to its sedating
qualities. Given trazodone's widespread use, a careful review of
the literature was conducted to assess its efficacy and side
effects when given for treatment of insomnia.
Data Sources: In April 2003, a MEDLINE search
was conducted using the search terms trazodone and insomnia and trazodone and sleep and restricted to 1980-2003, human
subjects, and English language. As trazodone has been implicated
in cardiac disorders, a further search was conducted using the
term cardiac and trazodone.
Study Selection: All clinical trials that
measured any endpoint for insomnia efficacy were included in the
assessment. A total of 18 studies were identified from the
literature search. In addition, commonly used texts were
consulted for information regarding adverse effects related to
Data Extraction: Because so few studies
were identified by the literature search, all were evaluated and
Data Synthesis: Evidence for the efficacy of
trazodone in treating insomnia is very limited; most studies are
small, conducted in populations of depressed patients, raise
issues of design, and often lack objective efficacy measures.
Side effects associated with trazodone are not inconsequential,
with a high incidence of discontinuation due to side effects,
such as sedation, dizziness, and psychomotor impairment, which
raise particular concern regarding its use in the elderly. There
is also some evidence of tolerance related to use of trazodone.
Conclusion: Given the relative absence of
efficacy data in patients with insomnia and the adverse events
associated with trazodone's use in general, it is uncertain
whether the risk/benefit ratio warrants trazodone's use in
nondepressed patients with insomnia.