Trazodone for sleep disturbance during methadone maintenance: a double-blind, placebo-controlled trial

Drug Alcohol Depend. 2012 Jan 1;120(1-3):65-73. doi: 10.1016/j.drugalcdep.2011.06.026. Epub 2011 Jul 27.


Background: To test whether trazodone, one of the most commonly prescribed medications for treatment of insomnia, improves subjective and/or objective sleep among methadone-maintained persons with sleep complaints, we performed a randomized, double-blind, placebo-controlled trial with 6-month follow-up.

Methods: From eight methadone maintenance programs in the northeastern United States, we recruited 137 persons receiving methadone for at least 1 month who reported a Pittsburgh Sleep Quality Index (PSQI) score of six or higher. Two-night home polysomnography (PSG) was completed at baseline and 1 month later, with morning surveys and urine drug toxicologies. Interviews assessed sleep over the past 30 days at baseline and 1-, 3-, and 6-month follow-ups.

Results: Participants averaged 38 years of age, were 47% male, and had a mean PSQI total score of 12.9 (±3.1). At baseline, intervention groups did not significantly differ on 10 PSG-derived objective sleep measures and 11 self-reported measures. Over 88% (n=121) of participants completed the PSG at 1-month. Without adjusting p-values for multiple comparisons, only 1 of 21 sleep measure comparisons was statistically significant (p<.05). The effect of trazodone on mean PSQI scores during the 6-month follow-up was not statistically significant (p=.10). Trazodone neither significantly increased nor decreased illicit drug use relative to placebo.

Conclusions: Trazodone did not improve subjective or objective sleep in methadone-maintained persons with sleep disturbance. Other pharmacologic and non-pharmacologic treatments should be investigated for this population with high rates of insomnia.

Keywords: Methadone; Opiate dependence; Sleep; Trazodone.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives / therapeutic use*
  • Male
  • Methadone / adverse effects
  • Methadone / therapeutic use*
  • Narcotics / adverse effects
  • Narcotics / therapeutic use*
  • Opiate Substitution Treatment / adverse effects*
  • Polysomnography
  • Sleep Wake Disorders / chemically induced
  • Sleep Wake Disorders / drug therapy*
  • Trazodone / therapeutic use*
  • Treatment Outcome


  • Hypnotics and Sedatives
  • Narcotics
  • Methadone
  • Trazodone