Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of sleep walking and sleep-related eating disorder

September 21, 2017

Product

Atypical antipsychotics

Potential Safety Issue

Sleep walking (SW) and sleep-related eating disorder (SRED)

Key Messages

• Atypical antipsychotics are authorized for sale in Canada to treat mental disorders including schizophrenia, bipolar disorder and depression.
• Health Canada reviewed the potential risk of sleep walking (SW) and sleep-related eating disorder (SRED) with the use of atypical antipsychotics, following the publication of a case report describing these events in a patient treated with ziprasidone.
• Health Canada's safety review has found a link between SW and SRED and the use of atypical antipsychotics. Health Canada has recommended to update the product safety information for all atypical antipsychotics to include these side effects.

Overview

Health Canada reviewed the potential risk of SW and SRED with the use of atypical antipsychotics, following the publication of a case report describing these events in a patient treated with ziprasidone. Sleep walking is a sleep disorder that causes people to get up and walk or do other complex actions while asleep. Sleep-related eating disorder is a variant of SW in which people get up frequently to eat and drink while asleep. As a consequence, the person may have dangerous behaviors such as cooking food while asleep, which may lead to injuries.

Use in Canada

• Atypical antipsychotics are authorized for sale in Canada to treat mental disorders such as schizophrenia, bipolar disorder and depression.
• There are 9 different atypical antipsychotics marketed in Canada since 1991: aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone. Some of these medications are available as generic versions.
• Sleep walking is currently mentioned in the product safety information for aripiprazole, lurasidone, paliperidone, quetiapine, and risperidone. Sleep-related eating disorder is only mentioned in the product safety information for lurasidone, paliperidone, quetiapine, and risperidone.
• In 2016, there were approximately 18 million prescriptions for atypical antipsychotics filled in Canada.

Safety Review Findings

• At the time of the review, Health Canada had received a total of 13 unique Canadian reports^{Footnote a} of SW and SRED suspected to be linked to the use of atypical antipsychotics. The review of these 13 reports suggested that in 2 cases the sleep disorders were likely linked to the use of atypical antipsychotics. The patients recovered when they stopped the treatment. Six (6) reports, out of 13, were found to have a possible link. Other risk factors such as pre-existing conditions, history of these sleep disorders or use of other medications, could have contributed to the events; however, a link could not be ruled out. The 5 remaining reports could not be assessed because there was not enough information.
• This safety review looked at information from 413 international reports of SW and SRED associated with the use of atypical antipsychotics, but these reports provided limited additional information.
• In addition, Health Canada found 23 published case reports of SW and SRED associated with the use of atypical antipsychotics. In the majority of these reports, patients recovered when they stopped the treatment and in some cases, the events returned when patients resumed the treatment. The drug was taken as recommended and the events appeared to happen more often with higher doses. Overall, the review of these case reports suggested a link between the use of atypical antipsychotics and SW and SRED.

Conclusions and Actions

• Health Canada's safety review has found a link between SW and SRED and the use of atypical antipsychotics. Health Canada has recommended to update the product safety information for all atypical antipsychotics to include these side effects.
• Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of these health products.
• Health Canada will continue to monitor safety information involving atypical antipsychotics, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of these drugs both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.