Table 1.
Number of EMA Database Z-Drug Misuse-, Abuse-, Dependence-, and Withdrawal-Related ADRs (2003–2017)
| Zaleplon | Zopiclone | Zolpidem | |
|---|---|---|---|
| Total no. ADRs | 4270 | 65 140 | 206 315 |
| Suspect abuse-, misuse-, dependence-, or withdrawal-related ADRs | 537 (12.58%) (IC 95%: 11.60–13.61%) | 9283 (14.25%) (IC 95%: 13.98–14.52%) | 23 420 (11.35%) (IC 95%: 11.21–11.49%) |
| No. of unique patients | 112 | 1760 | 4374 |
| Gender most typically represented | F (F/M ratio: 3.9) | F (F/M ratio: 1.09) | F (F/M ratio: 1.6) |
| Age range (y) most typically represented | 18–64 (39%) | 18–64 (68%) | 18–64 (65.7%) |
| ADRs most typically represented | Intentional overdose (51.9%), overdose (14.1%), drug use disorder (11.4%) | Intentional overdose (29.9%), overdose (23.1%), drug use disorder (23.1%) | Drug use disorder (40.0%), overdose (23.7%), intentional overdose (16.7%) |
| Concomitant drugs most typically represented | Antidepressants in 20/101 (19.8%) cases, benzodiazepines in 18/101 (17.8%) cases, ethanol/other Z drugs in 14/101 (13.9%) cases | Benzodiazepines in 891/4374 (20.4%) cases, antidepressants in 658/4374 (15.0%) cases, antipsychotics in 475/4374 (10.9%) cases | Antidepressants in 468/1760 (26.6%) cases, benzodiazepines in 334/1760 (19.0%) cases, opiates/opioids in 250/1760 (14.2%) cases |
Abbreviations: ADR, adverse drug reaction; CI, confidence interval; EMA, European Medicines Agency.