title: Varenicline and abnormal sleep related events.
abstract: OBJECTIVE
  To assess adverse drug reaction reports of "abnormal sleep related events" associated with varenicline, a partial agonist to the α4β2 subtype of nicotinic acetylcholine receptors on neurones, indicated for smoking cessation.
  
  
  METHODS
  Twenty-seven reports of "abnormal sleep related events" often associated with abnormal dreams, nightmares, or somnambulism, which are known to be associated with varenicline use, were identified in the World Health Organisation (WHO) Global Individual Case Safety Reports Database. Original anonymous reports were obtained from the four national pharmacovigilance centers that submitted these reports and assessed for reaction description and causality.
  
  
  RESULTS
  These 27 reports include 10 of aggressive activity occurring during sleep and seven of other sleep related harmful or potentially harmful activities, such as apparently deliberate self-harm, moving a child or a car, or lighting a stove or a cigarette. Assessment of these 17 reports of aggression or other actual or potential harm showed that nine patients recovered or were recovering on varenicline withdrawal and there were no consistent alternative explanations. Thirteen patients experienced single events, and two had multiple events. Frequency was not stated for the remaining two patients.
  
  
  CONCLUSIONS
  The descriptions of the reports of aggression during sleep with violent dreaming are similar to those of rapid eye movement sleep behavior disorder and also nonrapid eye movement (NREM) sleep parasomnias in some adults. Patients who experience somnambulism or dreams of a violent nature while taking varenicline should be advised to consult their health providers. Consideration should be given to clarifying the term sleep disorders in varenicline product information and including sleep related harmful and potentially harmful events.
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.|Department of General Practice, University of Otago, Christchurch, New Zealand.|New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, University of Otago, Dunedin.
authors.forename: Ruth L
authors.initials: RL
authors.lastname: Savage
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Alem
authors.initials: A
authors.lastname: Zekarias
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Pia
authors.initials: P
authors.lastname: Caduff-Janosa
mesh_terms: D000328:Adult; D000374:Aggression / Q000187:drug effects*; D001552:Benzazepines / Q000009:adverse effects*; D004325:Dreams / Q000187:drug effects*; D004348:Drug Labeling; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000009:adverse effects*; D020447:Parasomnias / Q000139:chemically induced; D060735:Pharmacovigilance; D011810:Quinoxalines / Q000009:adverse effects*; D012893:Sleep Wake Disorders / Q000139:chemically induced*; D016540:Smoking Cessation / Q000523:psychology; D013009:Somnambulism / Q000139:chemically induced; D000068580:Varenicline; D014944:World Health Organization
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline
keywords: aggression; nightmares; somnambulism; varenicline