OBJECTIVES: 1) To identify patient-reported outcomes used to complement assessments of seizure reduction in adult epilepsy drug trials; 2) to identify trials that specifically examined the impact of treatment on patient-reported anxiety, depression and sleep disturbance, as these common comorbid symptoms are associated with poorer health status in people with epilepsy; and, 3) to identify which measures/domains were most responsive to change. METHODS: A review of 41 adult epilepsy trials examining the impact of an oral antiepileptic drug on patient-reported assessments of anxiety, depression, well-being, sleep, function and treatment satisfaction. Studies were identified through searches in MEDLINE, the Cochrane Central Register of Controlled Trials and reference lists of published articles. RESULTS: The most common types of PROs comprised epilepsy-specific measures assessing multiple domains of functioning and well-being (used in 30 studies) and generic measures assessing anxiety/depression and other emotions (used in 21 studies). There was limited detection of treatment effect on scales assessing anxiety/depression and emotional well-being. Scales assessing perceptions of emotional well-being were more likely to show significant differences than measures assessing symptom severity. Patients were not required to have clinically significant anxiety/depression to participate. It is possible that patients entered trials with symptoms in the normal range, leaving no room to show improvement; that treatment did not worsen symptoms; or, that instruments were not responsive. Findings were mixed regarding other specific health status domains. Patients receiving active treatments typically reported significantly higher levels of satisfaction than those receiving placebo. Only 2 trials were identified that assessed patient-reported sleep, but both showed significant differences on specific domains. CONCLUSION: Anxiety and depression were among the most common PROs assessed, but there was limited detection of treatment effect. Trial selection criteria complicate interpretation of findings. Patient-reported sleep outcomes were rarely studied, but deserve more attention in adult epilepsy drug trials.