Trazodone Not More Effective Than a Placebo and Has More Side Effects

Trazodone is the second most widely prescribed sleep medication in the United States over the past 20 years (behind Ambien) despite the American Academy of Sleep Medicine recommendations not to use Trazodone for the treatment of insomnia. This recommendation is based on several studies of the efficacy of Trazodone vs. Ambien and placebo in which Ambien was more effective for insomnia. In a study comparing Trazodone and a placebo group in 187 adults with insomnia, participants were administered either Trazodone or placebo in a double-blind fashion for 14 consecutive nights. In this study, the Trazodone group experienced significantly more side effects than the placebo group. Chief among these were headache (Trazodone, 30%; placebo, 19%) and somnolence (Trazodone, 23%; placebo, 8%). In all, 75% of Trazodone participants reported adverse events. Additionally, there were no differences between Trazodone and placebo on sleep-onset latency, total sleep time, or wake after sleep onset, which is why the US Department of Veterans Affairs and the US Department of Defense Clinical Practice Guidelines also do not recommend Trazodone for the treatment of chronic insomnia. In short, Trazodone it is less effective than Ambien, no more effective than placebo, and carries side effects in the majority of patients.