title: Assessment of the effects of lacosamide on sleep parameters in healthy subjects.
abstract: OBJECTIVE
  Seizures and antiepileptic drugs (AED) may disrupt sleep patterns in patients with epilepsy, thus evaluation of lacosamide effects on objective and subjective sleep measures is warranted.
  
  
  METHODS
  A multicenter, interventional, open-label study (NCT01530386) was conducted in healthy subjects without confounding effects of concomitant AED use, co-morbidities, or disease state to determine whether lacosamide impacts sleep parameters after 22 days of lacosamide exposure. After overnight polysomnography (PSG) to assess baseline parameters, lacosamide was initiated at 100mg/day (50mg twice daily) and increased by 100mg/day weekly to 300 mg/day (the mid-range maintenance dose for adjunctive therapy). The primary variable was change from baseline to post-treatment in wake after sleep onset (WASO). Secondary variables included additional objective sleep measures, subject-reported measures of sleep quality, daytime sleepiness, and tolerability. Change from baseline in WASO was analyzed using the Wilcoxon rank-sum test.
  
  
  RESULTS
  A total of 27 subjects received ≥1 dose of lacosamide and 25 subjects completed the study. For WASO, median change from baseline was a 6-min reduction (95% confidence interval: -38, 77.5; p=0.1074) after lacosamide treatment; this was considered not clinically relevant. No clinically relevant changes were observed in any secondary variables. Thirteen subjects (48%) reported a treatment-emergent adverse event, none of which was severe or led to study discontinuation.
  
  
  CONCLUSIONS
  Lacosamide 300 mg/day had no effect on objective or subjective sleep parameters in healthy subjects and was generally well tolerated.
authors.affiliation: Sleep Medicine Consultants, 5508 Parkcrest Drive, Suite #310, Austin, TX 78731, USA. Electronic address: jdh@sleepdoc.net.
authors.forename: J Douglas
authors.initials: JD
authors.lastname: Hudson
authors.affiliation: Duke Clinical Research Institute, 2400 Pratt Street, Room 0311 Terrace Level, Durham, NC 27705, USA. Electronic address: jeffrey.guptill@duke.edu.
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Guptill
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Bill.Byrnes@ucb.com.
authors.forename: William
authors.initials: W
authors.lastname: Byrnes
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Stephen.Yates@ucb.com.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Yates
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Paulette.Williams@ucb.com.
authors.forename: Paulette
authors.initials: P
authors.lastname: Williams
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: oneill_dcruz@yahoo.com.
authors.forename: O'Neill
authors.initials: O
authors.lastname: D'Cruz
mesh_terms: D000081:Acetamides / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D012890:Sleep / Q000187:drug effects* / Q000502:physiology; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Lacosamide; Pharmacodynamics; Sleep; Tolerability