levetiracetam and Sleep-Initiation-and-Maintenance-Disorders

To evaluate the long-term efficacy and tolerability of adjunctive levetiracetam (LEV) in patients with uncontrolled idiopathic generalized epilepsy (IGE).. This phase III, open-label, long-term, follow-up study (N167; NCT00150748) enrolled patients (4 to <65 years) with primary generalized seizures (tonic-clonic, myoclonic, absence). Patients received adjunctive LEV at individualized doses (1,000-4,000 mg/day; 20-80 mg/kg/day for children/adolescents weighing <50 kg). Efficacy results are reported for all seizure types [intention-to-treat (ITT) population, N = 217] and subpopulations with tonic-clonic (n = 152), myoclonic (n = 121), and/or absence (n = 70) seizures at baseline.. One hundred twenty-five (57.6%) of 217 patients were still receiving treatment at the end of the study. Mean (standard deviation, SD) LEV dose was 2,917.5 (562.9) mg/day. Median (Q1-Q3) exposure to LEV was 2.1 (1.5-2.8) years, and the maximum duration was 4.6 years. Most patients were taking one (124/217, 57.1%) or ≥2 (92/217, 42.4%) concomitant antiepileptic drugs (AEDs). Seizure freedom of ≥6 months (all seizure types; primary efficacy end point) was achieved by 122 (56.2%) of 217 patients, and 49 (22.6%) of 217 patients had complete seizure freedom. Seizure freedom of ≥6 months from tonic-clonic, myoclonic, and absence seizures was achieved by 95 (62.5%) of 152, 75 (62.0%) of 121, and 44 (62.9%) of 70 patients, respectively. Mean (SD) maximum seizure freedom duration was 371.7 (352.4) days. At least one treatment-emergent adverse event (TEAE) was reported by 165 (76%) of 217 patients; most TEAEs were mild/moderate in severity, with no indication of an increased incidence over time. Seventeen (7.8%) of 217 patients discontinued medication because of TEAEs. The most common psychiatric TEAEs were depression (16/217, 7.4%), insomnia (9/217, 4.1%), nervousness (8/217, 3.7%), and anxiety (7/217, 3.2%).. Adjunctive LEV (range 1,000-4,000 mg/day) demonstrated efficacy as a long-term treatment for primary generalized seizures in children, adolescents, and adults with IGE, and was well tolerated.

Topics: Adolescent; Adult; Anticonvulsants; Anxiety; Child; Child, Preschool; Depression; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Levetiracetam; Male; Middle Aged; Piracetam; Seizures; Sleep Initiation and Maintenance Disorders; Time Factors; Treatment Outcome; Young Adult

Zolpidem is an imidazopyridine nonbenzodiazepine hypnotic drug with a high affinity to the α1 subunit of the gamma amino butyric acid A receptor It is the first pharmacological option in the short-term management of sleep-onset insomnia. Initially considered a safer drug compared to benzodiazepines because of lower liability for abuse and dependence, recently, an increasing body of reports has questioned zolpidem's proneness to misuse. In this report, we describe a case of serious zolpidem abuse requiring pharmacological washout during hospitalization because of previous withdrawal seizures in a patient with chronic sleep-onset and maintenance insomnia.

Topics: Aged; Anticonvulsants; Chronic Disease; Clonazepam; Female; Hospitalization; Humans; Levetiracetam; Pregabalin; Seizures; Selective Serotonin Reuptake Inhibitors; Sertraline; Sleep Aids, Pharmaceutical; Sleep Initiation and Maintenance Disorders; Substance-Related Disorders; Zolpidem

This study investigated the effect of the novel antiepileptic drug levetiracetam (LEV) on sleep in eleven patients with partial epilepsy. At baseline and one week after therapy with LEV (1000 mg/day), patients underwent polysomnography (PSG) and the Multiple Sleep Latency Test (MSLT). Patients also rated their own degree of sleep disturbance and daytime sleepiness with the Athens Insomnia Scale (AIS) and the Epworth Sleepiness Scale (ESS). A group of 10 age- and gender-matched control participants were also included in the study. Patients had decreased total sleep time and increased daytime sleepiness compared to baseline, as evaluated by AIS subscales. Furthermore, LEV therapy significantly decreased the rapid eye movement sleep time and percentage as measured by PSG. Patients reported a significant increase in ESS score but did not exhibit changes in MSLT performance after LEV treatment. The study demonstrated that short-course LEV treatment can affect subjective sleep time and objective sleep architecture. Furthermore, LEV treatment affected subjective daytime sleepiness but did not influence objective mean daytime sleep latencies in patients with partial epilepsy.

Topics: Adolescent; Adult; Aged; Anticonvulsants; Disorders of Excessive Somnolence; Electroencephalography; Epilepsies, Partial; Female; Humans; Levetiracetam; Male; Middle Aged; Piracetam; Polysomnography; Severity of Illness Index; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Young Adult

Topics: Anticonvulsants; Anxiety; Drug Therapy, Combination; Epilepsies, Partial; Female; Humans; Levetiracetam; Middle Aged; Piracetam; Psychomotor Agitation; Sleep Initiation and Maintenance Disorders; Valproic Acid

Seizures are a common neurologic symptom of tuberous sclerosis complex. The use of levetiracetam as adjunctive antiepileptic therapy was assessed in 20 patients with tuberous sclerosis complex aged 2 to 19 years. In this retrospective evaluation, 40% of patients treated with levetiracetam achieved a seizure reduction of more than 50%. Levetiracetam was generally well tolerated, and adverse events were relatively uncommon in patients who responded to treatment. The most commonly reported adverse events were behavioral problems. Unstable gait, insomnia, poor appetite, and increased seizure frequency were also reported. Based on these results, the use of levetiracetam as adjunctive antiepileptic therapy can reduce seizure frequency in patients with tuberous sclerosis complex. (J Child Neurol 2006;21:53-57).

Topics: Adolescent; Adult; Anorexia; Anticonvulsants; Behavioral Symptoms; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Gait Disorders, Neurologic; Humans; Infant; Levetiracetam; Male; Piracetam; Retrospective Studies; Seizures; Sleep Initiation and Maintenance Disorders; Treatment Outcome; Tuberous Sclerosis