Somnolence lacosamide

Lacosamide 200 and 400 mg/day as addon therapy in 485 patients with uncontrolled partial-onset seizures has been studied in a multicenter, double-blind, placebo-con-trolled trial, which consisted of an 8-week baseline, a 4-week titration period, and a 12-week maintenance period [137 ]. The median percentage reduction in seizure frequency was 21% for placebo, 35% for lacosamide 200 mg/day, and 36% for 400 mg/ day. The most clearly dose-related treatment-emergent adverse events included dizziness (17 and 25 patients randomized to 200 or 400 mg of lacosamide respectively), nausea (9 and 13 patients), and vomiting (5 and 9 patients). Diplopia (13 and 16 patients) did not appear to be dose-related. The incidence of somnolence was low (4.3%, 3.8%, and 3.7% in patients randomized to lacosamide 200 mg, 400 mg, and placebo respectively). The experimental drug was withdrawn in 42 patients because of adverse effects eight had been randomized to placebo, 10 to lacosamide 200 mg/day, and 24 to 400 mg/day. The adverse effects... 

Observational studies So-called third generation antiepileptic medications include retigabine, lacosamide, and esli-carbazepine. All three AEDs have linear pharmacokinetics and rapid absorption. The most common adverse effects observed with lacosamide versus placebo were dizziness, headache, diplopia, and nausea with retigabine, they were dizziness, somnolence, and fatigue and with eslicarbazepine acetate, dizziness and somnolence were reported [26 ]. 

Observational studies A multicenter prospective study of patients taking lacosamide reported the following adverse effects dizziness (6.8%), headache (5.9%), somnolence, vomiting, and dyspepsia in 4.3% each, irritability (3.4%), and diplopia, paresthesias, balance disorder, and fatigue in less than 2% each [70 ]. 

A 4-year-old girl with epilepsy who had been stable on VPA developed toxicity after addition of lacosamide. Symptoms included somnolence, xmsteady gait, dizziness, decreased appetite, thrombocytopenia, and elevated serum ammonia level. The symptoms resolved after withdrawal of both medications [199 ]. Although there was a temporal relationship between addition of lacosamide and the development of symptoms, a causal drug interaction was not established in this case. 

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