(080) Identification of a novel signal congenital scoliosis for zopiclone through FDA FAERS database

Publication Number: 1075

Background: Zopiclone is a sedative medication approved by Food and Drug Administration (FDA) for the treatment of chronic primary insomnia. The common adverse drug reactions (ADRs) of zopiclone are muscle tone disorder, congenital hand malformations, muscle spasticity and schizoaffective disorder.

Objectives: This study was conducted to know the possible ADRs of zopiclone which have not yet been established. The Openvigil database was used to find an association.

Methods: FDA Adverse Event Reporting System (FAERS) is an ADR management database utilized for disproportionality analysis. Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) with 95% confidence intervals (CIs) were considered as disproportionality measures to assess the degree of association of zopiclone with congenital scoliosis. The Openvigil database was used to find the association. The signals with minimum threshold values of ROR -1.96SE > 1 (SE-standard error), PRR ≥ 2, number of co-occurrences ≥ 3 were considered as positive signal.

Results: Zopiclone showed new signal for congenital scoliosis. It showed PRR of 83, ROR of 84 and 11 drug-event combinations. Zopiclone was reported to cause congenital musculoskeletal anomaly among 12 patients and congenital hand malformations among 14 patients. Zopiclone associated muscle tone disorder showed highest PRR (141.7), immune mediated hepatitis (37), congenital musculoskeletal anomaly (21), congenital hand malformation (19), neuroleptic malignant syndrome (15.7), trismus (14.3), muscle spasticity (14.1), schizoaffective disorder (13.3), nystagmus (9.56) and hepatitis fulminant (7.5).

Conclusions: Zopiclone associated congenital scoliosis is a new signal generated to alert the health care practitioners to monitor the administration of zopiclone among pregnant and lactating mothers and patients using zopiclone for the treatment of insomnia. Health care practitioners should be aware of the novel signals of zopiclone.