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Among the most promising advances in the pharmacological treatment of PTSD have been a series of placebo-controlled augmentation trials demonstrating the efficacy of the -adrenergic antagonist prazosin for the treatment of trauma-related nightmares and sleep disruption (24–26). In these trials, patients were allowed to continue maintenance medications, including SSRIs, as the primary outcome variables were related to sleep disturbance rather than daytime PTSD symptoms. However, the studies also assessed total PTSD symptoms using either the CAPS or the PTSD Checklist–Civilian Version (PCL-C).

The first study, reported in 2003 by Raskind et al. (24), was a double-blind, crossover trial in which 10 Vietnam combat veterans with PTSD received placebo or prazosin (mean dosage = 9.6 mg/night) over a 3-week dose-titration phase and a 6-week maintenance phase. Prazosin was significantly superior to placebo in reducing nightmares (CAPS "recurrent distressing dreams" item) and sleep disturbance (CAPS "difficulty sleeping" item) and in improving global clinical status (Clinical Global Impression of Change [CGIC]), with effect size z >1.0 on all measures. Change in total CAPS score and scores on all three CAPS cluster items was also significantly greater with prazosin than with placebo.

The second study, reported in 2007 by Raskind et al. (25), was a parallel-group trial in 40 veterans with chronic PTSD, most of whom experienced combat-related trauma in Vietnam. Patients received placebo or prazosin (mean dosage = 13.3 mg/night) during a 4-week dose-titration phase and an 8-week maintenance phase. Similar improvements were observed in nightmares, sleep disturbance, and CGIC scores (effect size = 0.9). A numerically greater reduction in total CAPS score was observed with prazosin, but this did not reach statistical significance.

Finally, in a double-blind, placebo-controlled crossover study of 13 civilians with trauma-related PTSD, reported in 2008 by Taylor et al. (26), prazosin was rapidly titrated to 3 mg/night during each 3-week treatment phase. Along with clinical outcomes, sleep time and sleep latency were recorded in the final 3 nights of the treatment phase. Total sleep time was 94 minutes longer with prazosin than with placebo (374 +/–86 minutes compared with 280 +/–105 minutes, p <0.01, effect size = 0.98), and total rapid eye movement (REM) sleep and mean REM duration were also longer with prazosin. Once again, reductions in trauma nightmares, total PTSD symptoms (using the PCL-C) and CGIC scores were significantly changed compared with placebo.

Further investigation may clarify an optimal dosage and titration for prazosin, which based on the above studies appears to be effective in a range of 3–15 mg/night. Clinically, a low dose could be tried and then increased if response is inadequate. Long-term efficacy has not been established.

References

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