Somnolence lamotrigine

In 126 patients with carbamazepine-resistant or valproate-resistant epilepsy given lamotrigine, 50% during add-on therapy and 53% during lamotrigine monotherapy had at least 50% reduction in total seizures (15). There were adverse events in 49 patients, including respiratory tract infections n — 11), dizziness (n — 8), headache (n = 7), diplopia (n = 5), tremor (n = 5), somnolence (n — 4), insomnia (n = 4), nausea (n — 4), and weakness (n = 3). Treatment was discontinued in nine patients because of adverse events, in five cases because of rash. 

The most common adverse effects of lamotrigine include dizziness, weakness, headache, diplopia, ataxia, blurred vision, and somnolence (SEDA-18, 65) (SEDA-20, 63) (19). These effects resemble those seen with carbamaze-pine and can result from an adverse pharmacodynamic interaction. Tolerability is better when lamotrigine is given as monotherapy or with drugs other than carbama-zepine however, tremor develops in some patients taking valproate in combinations (SEDA-18, 66). During monotherapy, serum lamotrigine concentrations associated with intolerable adverse effects (mostly headache, dizziness, and ataxia) were 0.4-18.5 qg/ml and overlapped widely with those tolerated in other patients (20). 

Nervous system The effects of lamotrigine (n=29), levetiracetam (n = 38), and pheno-barbital (n=28) have been evaluated in patients with seizures and Alzheimer s disease in a prospective, randomized, three-arm parallel-group, case-control study with a 4-week dosage adjustment and a 12-month evaluation period [180. The adverse reactions were somnolence (30%) and weakness (13%). Patients treated with lamotrigine showed a slight decline in Mini Mental Test scores and other cognitive scores and scored better on measures of mood. 

Placebo-controUed studies In a 16-week, double-blind, placebo-controlled, flexible-dose study of lamotrigine in binge-eating disorder associated with obesity, 51 outpatients were randomized to either lamotrigine (n = 26) or placebo (n = 25) [146 ]. Four patients withdrew because of adverse events (lamotrigine, n = 3 placebo, n = 1), the most common of which were headache (35% versus 28%), insomnia (35% versus 20%), somnolence (27% versus 8%), rash (15% versus 12%), and dry mouth (15% versus 0%). 

Systematic reviews The major studies on the safety and tolerability of rufinamide were reviewed [157 ]. In placebo-controlled trials and pooled analyses, the most common adverse effects reported with rufinamide were somnolence and vomiting. Headache and pyrexia were also reported more frequently with rufinamide compared to placebo. In terms of drug-drug interactions, rufinamide may slightly increase the clearance of CBZ and lamotrigine and may slightly decrease the clearance of phenytoin and phenobarbital. VPA may significantly decrease the clearance of rufinamide. 

---