![]() Study participants were male (147/374) and female (227/374) adult outpatients, aged 18-65 years, meeting DSM IV-TR criteria for GAD. Briefly, patients were randomized to 8 weeks of flexible-dose treatment with pregabalin (300-600 mg/day), venlafaxine XR (75-225 mg/day) or placebo. The full methodology and results of this trial have been described elsewhere 22. The primary endpoint in the study was anxiety symptom change, measured by Hamilton Anxiety Rating Scale (HAM-A) total score, from baseline to the last post-randomization visit prior to dose tapering. Using a statistical mediation model, we further sought to ascertain the extent to which pregabalin's effect on sleep disturbance is attributable to a direct effect of the drug, as well as an indirect effect mediated through anxiety symptoms.ĭata were obtained from a randomized, double-blind, flexible-dose, parallel-group, placebo- and active-controlled study in 394 patients with GAD. ![]() In this study, we fully describe the effects of pregabalin on sleep and further characterize the beneficial effects of pregabalin on frequency and intensity of sleep disturbances in GAD. In healthy volunteers, it increases slow-wave sleep as a proportion of both the total sleep period and the duration of stage 4 sleep, and reduces the number of awakenings of more than 1 minute in duration 21.Ī recent trial of pregabalin in GAD 22 included subjective assessment of sleep using the Medical Outcomes Study Sleep Scale (MOS-SS). It has also demonstrated substantial beneficial effects on sleep. Pregabalin, a ligand for the a 2 d subunit of voltage-gated calcium channels, has been shown to effectively reduce the symptoms of GAD 18-20. Insomnia rates reported with the serotonin-norepinephrine reuptake inhibitors (SNRIs) duloxetine and venlafaxine appear to be similar to those reported for SSRIs 16,17. It is well established that insomnia is reported as an adverse event with many SSRIs - across anxiety and depression indications, insomnia rates are 9-28% 12-15. There are strong indications that SSRIs might also have sleep-disrupting effects in patients with GAD. SSRIs have also been reported to reduce the latency and duration of rapid eye movement sleep 11. In healthy volunteers, SSRIs, such as paroxetine and fluvoxamine, reduce sleep efficiency and increase the number of awakenings and sleep onset latency 10. ![]() While benzodiazepines appear to improve measures of sleep onset and/or sleep maintenance 9, selective serotonin reuptake inhibitors (SSRIs) tend to have a disruptive effect on sleep. Polysomnography studies in patients with GAD have revealed sleep abnormalities including problems with sleep latency, early morning insomnia, decrease in total sleep time, and sleep architecture 5,6.Įpidemiological surveys in primary care have further highlighted that alongside pain, sleep disturbances are the most frequent presenting complaints of patients with GAD and have a strong negative impact on anxiety symptoms and patient functioning 7,8.ĭifferent classes of agents used for the treatment of GAD have different effects on sleep. The mediation model indicated that 53% of the total pregabalin effect on sleep disturbance was direct (p 65 years) 4. ![]() Venlafaxine XR (n = 125) had no significant effect on these measures. Results: Compared with placebo (n = 128), treatment with pregabalin (n = 121) significantly reduced scores on the sleep disturbance subscale and Sleep Problems Index II at both week 4 and week 8, and the sleep adequacy subscale at week 8. A mediation model was used to estimate separately for both treatment arms the direct and indirect treatment effects on sleep disturbance. Anxiety symptoms were assessed with the Hamilton Anxiety Rating Scale. Treatment effect on sleep was evaluated using the Medical Outcomes Study Sleep Scale. Patients received pregabalin 300 mg/day, venlafaxine XR 75 mg/day or placebo for a week, followed by pregabalin 300-600 mg/day, venlafaxine XR 75-225 mg/day, or placebo for 7 weeks. Methods: A post-hoc analysis of data from a randomized, double-blind, placebo- and active-controlled study in patients with GAD was conducted. Germanyīackground and Objectives: To characterize the impact of pregabalin on sleep in patients with generalized anxiety disorder (GAD) and to determine whether the impact is a direct or an indirect effect, mediated through the reduction of anxiety symptoms. ** Pfizer Inc, Global Research and Development, New London. * Novartis Pharmaceuticals Corporation, Florham Park, New Jersey Cappelleri** Chwen-Cheng Chen** Douglas Feltner** Hans-Ulrich Wittchen*** Pregabalin reduces sleep disturbance in patients with generalized anxiety disorder via both direct and indirect mechanisms
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