Somnolence pregabalin

Gabapentin, a non-benzodiazapine GABA analog, was modestly effective in a 14-week controlled trial in SAD. Most patients were titrated to a maximal dose of 3600 mg/day.58 Pregabalin 600 mg/day was effective for social anxiety, fear, and avoidance behavior in a 10-week controlled trial.63 Pregabalin was well tolerated, and the most common side effects were somnolence and dizziness. 

Most common adverse reactions in all controlled clinical studies Blurred vision, dizziness, dry mouth, edema, somnolence, thinking abnormal (primarily difficulty with concentration/attention), and weight gain were more commonly reported by subjects treated with pregabalin. 

Pregabalin As for gabapentin Well absorbed orally not bound to plasma proteins not metabolized ti/2 6—7 h Partial seizures Toxicity Somnolence, dizziness, ataxia Interactions Minimal... 

Observational studies Pregabalin has been evaluated in an open 21-week study in 476 adults (mean age 40 years) with partial seizures inadequately controlled with one to three antiepileptic drugs 7% discontinued for lack of efficacy and 12% because of adverse events [247 ]. The three most common adverse reactions were dizziness (17%), somnolence (13%), and weight gain (13%). 

Systematic reviews In a meta-analysis of pregabalin trials in patients with fibromyalgia, four high-quahty randomized trials were included [257 ]. Only a minority of patients achieved moderate or substantial pain rehef. The proportions of patients with any adverse event, somnolence or dizziness, were significantly greater with pregabalin than with placebo. There was no difference with regard to serious adverse events. 

Pregabalin The combination of controlled-release oxycodone with pregabalin reduced the incidence of somnolence associated with oxycodone in 169 patients compared with 106 on oxycodone alone [145 ]. 

Observational studies An open label study of pregabalin for refractory seizures in 136 Mexican patients found that the most common adverse events were somnolence (39.7%), dizziness (16.2%), and weight gain (14%) [139 -]. 

Of the 20 patients receiving pregabalin for depression, eight reported concentration difficulties, seven reported somnolence, six reported headache, six reported dry mouth, five reported diarrhea, four reported dizziness, and three each reported blurred vision, weight gain, and edema [llO ]. 

Systematic reviews A meta-analysis of pregabalin use in generalized anxiety disorder found that the most adverse effects reported were somnolence, dizziness, headache, and dry mouth [142 ]. 

A meta-analysis of pregabalin safety in Japan as compared to Western coxmtries [143 ] found that dizziness and somnolence were the most common adverse effects, and that they tended to occur early in the course of pregabalin treatment and later resolved. A slightly higher incidence of dizziness and somnolence was reported in Japanese studies as compared to those from Western nations. The authors speculated that this may be related to the lower mean body weight in the Japanese population leading to a higher mg/kg dose. 

---