A safety signal of somnambulism with the use of antipsychotics and lithium: A pharmacovigilance disproportionality analysis

Abstract

Aims Antipsychotics and lithium are widely used in psychiatry, particularly in schizophrenia and bipolar disorders. Recently, some cases of somnambulism or sleep‐related eating disorder (SRED) have been reported in patients treated with these drugs. This study investigated the risk of reporting somnambulism or SRED associated with the use of antipsychotics and lithium. Methods The World Health Organization pharmacovigilance database (VigiBase), comprising >18 million adverse events, was queried. All somnambulism or SRED reports related to antipsychotics or lithium were identified. The association between antipsychotics or lithium and somnambulism or SRED was computed using the proportional reporting ratio (PRR) and information component. Results Among the 5784 cases reporting somnambulism or SRED, 508 suspected at least 1 antipsychotic or lithium. Most patients were aged 18–64 years (62.0%), and 37.0% were men. In most cases (77.6%), antipsychotic or lithium were the only drug class involved, and 53.3% of cases suspected quetiapine. Somnambulism was reported in 88.6% of cases and SRED in 18.1%. A significant association was found for second‐generation antipsychotics (PRR 3.44, 95% confidence interval 3.13) and lithium (PRR 2.03, [1.22; 3.37]), but not for first‐generation antipsychotics (PRR 0.99, [0.68; 1.44]). Conclusions We found a significant signal of somnambulism or SRED related to second‐generation antipsychotics and lithium. While case reports mentioned mostly quetiapine and olanzapine, almost all second‐generation antipsychotics were associated with somnambulism or SRED.

Abuse and misuse of second‐generation antipsychotics: An analysis using VigiBase, the World Health Organisation pharmacovigilance database

“…VigiBase is the World Health Organisation (WHO) global database that collects potential side effects of medicinal products 10 . Many studies have been carried out on psychotropic drugs, including antipsychotics, based on data extracted from the VigiBase 11,12 . Moreover, early signals of drug abuse have already been highlighted using data from the VigiBase database 13 …”

“…10 Many studies have been carried out on psychotropic drugs, including antipsychotics, based on data extracted from the VigiBase. 11,12 Moreover, early signals of drug abuse have already been highlighted using data from the VigiBase database. 13 The objective of this study was to analyse the worldwide data collected in the VigiBase database to identify potential abuse/misuse signals concerning SGAPs.…”

Medications as a Trigger of Sleep-Related Eating Disorder: A Disproportionality Analysis

“…One-fifth of the SRED cases are related to AAPs. Quetiapine, ziprasidone, aripiprazole, lurasidone, and olanzapine have been associated with SRED [37,38]. Quetiapine stands out in terms of number of cases and disproportionality.…”

Olanzapine-Related Somnambulism

“…[16][17][18][19][20][21][22] On the other hand, a recent large pharmacovigilance analysis reported a significant signal of SWor sleep-related eating disorders (SREDs) associated to second-generation antipsychotics, mainly to quetiapine and olanzapine, followed by aripiprazole, even if almost all secondgeneration antipsychotics, except risperidone and paliperidone, were associated with SW or SRED. 11 Psychiatric disorders, such as schizophrenia, bipolar disorder, and depression, are also associated with parasomnias, and they may increase the chance of SW. 18 However, to our knowledge, there are no previously reported cases of olanzapine-related somnambulism in eating disorders (EDs).…”

“…3 Somnambulism can be the consequence of psychological stress, abnormal breathing during sleep, high fever, or drug adverse effects. 4 Indeed, previous studies reported several kinds of drug-related somnambulism, including zolpidem, 5 paroxetine, 6 bupropion, 7 valproate, 8 topiramate, 9 lithium, 10,11 propranolol, 12 and first- 13,14 and secondgeneration 11,15 antipsychotics. Indeed, the association between drugs and SW is well documented, 16 and even somnambulism as a result of second-generation antipsychotic treatment has been previously reported.…”