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SAFETY ASSESSMENT OF ZOLPIDEM EFERVESCENT TABLETS BY PHARMACOGIVILANCE DATA
Insomnia can be defined as a persistent difficulty in starting, lasting or consolidating sleep, which can lead to fatigue, impaired social or occupational functioning and reduced quality of life. Patients with insomnia are at greater risk of mistakes and accidents in the workplace and use of health care systems more often. Zolpidem is an agonist of the gamma-aminobutyric acid receptor type A (GABA-A), which has sedative-hypnotic activity and stands out among the pharmacological treatments for the management of insomnia. As it is a drug widely used in clinical practice, it is of great importance to assess its safety through pharmacovigilance (PhV) reports.
To evaluate the PhV data of the zolpidem hemitartrate effervescent (ZEF) tablets comparing them to the events reported in the World Health Organization database, Vigiaccess.
Reports of adverse events related to the ZEF tablets were included from the pharmacovigilance database from 11/01/2017 to 8/31/2021 and compared to the most common events described in Vigiaccess.
During the analysis period, approximately 976,626 patients were exposed to the ZEF tablets. A total of 150 adverse events were reported to PhV in the period, 145 of which were classified as non-serious; the most frequent were somnolence (8), headache (6), exacerbated insomnia (5) and dizziness (4). Serious events were: attempted suicide (2), syncope (1), urinary tract infection (1) and pneumonia (1), considered possibly related to the drug. According to Vigiaccess data, since 1988, 39,092 reports of adverse events were registered, the most prevalent being: nausea, drug ineffective, toxicity to various agents, fall, overdose, amnesia, somnolence, dizziness, headache, memory impairment, loss of consciousness, product substitution issue, suicide and attempt, confusional state, somnambulism, delirium, hallucination, insomnia, drug dependence and abuse.
The incidence of adverse events of the ZEF tablets was observed in 0.02% of the cases and considered rare, 96.7% of them were a non-serious nature. Reported post-marketing surveillance data are consistent with global pharmacovigilance data for zolpidem.
zolpidem, pharmacovigilance, adverse events, safety
Stephanie Toscano Kasabkojian, Eduardo Quinalha Carbone, Ariane Delfino Oliveira, Karen Sacomam Barbosa, Antonio Carlos Amedeo Vattimo, Stevin Zung