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Trazodone Sleep Architecture Impact: What the Evidence Actually Shows

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At a glance

  • Label indication / major depressive disorder in adults; no insomnia indication or dose [3]
  • Key polysomnography trial / 16 primary insomniacs, trazodone 50 mg nightly for 7 days [1]
  • Slow-wave sleep / greater than placebo on day 7, not day 1 [1]
  • REM sleep / suppression reported with trazodone in a review of antidepressant trials [4]
  • Drowsiness in label depression trials / 41% with trazodone vs 20% with placebo [3]

What the polysomnography evidence shows

A randomized, double-blind, placebo-controlled study measured trazodone's effect on sleep in insomnia: 16 adults, mean age 44, with sleep efficiency of 85% or less on polysomnography, took 50 mg thirty minutes before bed for seven days [1]. Compared with placebo, trazodone produced fewer night-time awakenings, fewer minutes of Stage 1 sleep and fewer self-reported sleep difficulties. Slow-wave sleep was greater only on day 7, not day 1 [1]. The same study found small but significant impairments of short-term memory, verbal learning, balance and arm muscle endurance, assessed the morning after days 1 and 7 [1].

A 2005 review of 18 studies, most small and many in depressed patients, called the efficacy evidence very limited and noted some evidence of tolerance [2].

Does trazodone suppress REM sleep?

A systematic review of antidepressant sleep effects reports that REM sleep suppression has been observed with trazodone, as with SSRIs, MAOIs and most tricyclics [4]. A separate review of antidepressants in general found the REM decrease is greatest early in treatment and gradually diminishes during long-term treatment, except with MAOIs [5].

What the label says to watch for

Label rates come from controlled studies in major depression, not from sleep trials [3]. In 157 outpatients on trazodone versus 158 on placebo, drowsiness occurred in 41% versus 20%, dizziness or lightheadedness in 28% versus 15%, hypotension in 4% versus 0% and syncope in 5% versus 1% [3].

The label states that trazodone prolongs the QT/QTc interval and that torsades de pointes and ventricular tachycardia have been reported after marketing at doses of 100 mg/day or less with the immediate-release tablets; it advises avoiding the drug in known QT prolongation, a history of arrhythmia, low potassium or magnesium, congenital long QT, and the initial recovery phase after a heart attack, and avoiding combining it with other QT-prolonging drugs [3]. It also tells men to stop the drug and get emergency care for any erection lasting more than 4 hours, painful or not [3].

Does the effect last?

The 16-patient trial measured outcomes over seven days [1], and the 2005 review noted some evidence of tolerance [2].

Frequently asked questions

Does trazodone increase deep sleep?
In the randomized polysomnography study of 16 adults with insomnia, 50 mg nightly produced more slow-wave sleep than placebo on day 7 but not on day 1, with fewer night-time awakenings and less Stage 1 sleep [1]. A 2005 review of 18 studies called the efficacy evidence very limited [2].
Is trazodone approved for sleep?
No. The label lists one indication, major depressive disorder in adults, so sleep use is off-label [3]. It is not a controlled substance [3].
What dose is used for sleep?
The label gives no sleep dose. Its depression regimen starts at 150 mg a day in divided doses [3]. The 16-patient polysomnography trial used 50 mg thirty minutes before bed [1].
Does trazodone affect heart rhythm?
Yes. The label states that trazodone prolongs the QT/QTc interval, with torsades de pointes reported after marketing at 100 mg/day or less with immediate-release tablets [3].

References

  1. Roth AJ, McCall WV, Liguori A. Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs. J Sleep Res. 2011;20(4):552-8. Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs
  2. Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry. 2005;66(4):469-76. A review of the evidence for the efficacy and safety of trazodone in insomnia
  3. U.S. National Library of Medicine, DailyMed. Trazodone hydrochloride tablets (Oxford Pharmaceuticals) prescribing information. Trazodone hydrochloride tablets (Oxford Pharmaceuticals) label
  4. Mayers AG, Baldwin DS. Antidepressants and their effect on sleep. Hum Psychopharmacol. 2005;20(8):533-59. Antidepressants and their effect on sleep
  5. Wilson S, Argyropoulos S. Antidepressants and sleep: a qualitative review of the literature. Drugs. 2005;65(7):927-47. Antidepressants and sleep: a qualitative review of the literature
Evidence overview for Trazodone Sleep Architecture Impact: What the Evidence Actually Shows