β-adrenoceptor antagonists and nightmares: A pharmacoepidemiological-pharmacodynamic study.
Philippe Garcia, Jean-Louis Montastruc, Vanessa Rousseau, Jacques Hamard, Agnès Sommet, François Montastruc
Journal of Psychopharmacology July 28, 2021 DOI: 10.1177/02698811211034810 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Pharmacovigilance disproportionality analysis Peer reviewed |
|---|---|
| Population | Individual case safety reports involving beta-adrenoceptor antagonists in VigiBase from 1967 to 2019 |
| Topics | Dreaming |
| Keywords | Humans Adrenergic beta-antagonists Dreams Pharmacoepidemiology Pharmacovigilance Databases, pharmaceutical Adverse drug reactions Vigibase Beta adrenergic antagonists |
| Key points | Nightmares were reported in 0.9% of 126,964 beta-blocker case reports. Reporting odds were highest for pindolol (adjusted ROR 2.82), metoprolol (1.89), and alprenolol (1.77). Beta-blockers with moderate or high lipid solubility and those with moderate or high 5-HT1A affinity were associated with higher odds of nightmare reports than low-solubility or low-affinity drugs. |
Abstract
Aim: To compare different β-adrenoceptor antagonists for the risk of reporting nightmare.
Methods: The study involved two approaches: first, we investigated in VigiBase®, the World Health Organization Individual Case Safety Report (ICSR) database, the disproportionality between exposure to each β-adrenoceptor antagonists and reports of nightmares between 1967 and 2019. Second, in a pharmacoepidemiological-pharmacodynamic analysis, we assessed whether use of β-adrenoceptor antagonists with moderate and high lipid solubility or strong 5-HT1A affinity were associated with an increased risk of reporting nightmares. We conducted multivariate logistic regression to estimate reporting odds ratios (RORs) of nightmares compared to all other adverse drug reactions.
Results: Of the 126,964 reports recorded with β-adrenoceptor antagonists, 1138 (0.9%) were nightmares. The highest risk of reporting a nightmare was found with exposure of pindolol (adjusted ROR 2.82, 95%CI, 2.19-3.61), metoprolol (1.89, 1.66-2.16), and alprenolol (1.77, 1.06-2.97). Compared to use of low lipid solubility β-adrenoceptor antagonists, use of moderate or high lipid solubility β-adrenoceptor antagonists were significantly more associated with nightmare reports (aROR moderate vs. low 1.72, 95%CI 1.47-2.00 and aROR high vs. low 1.84, 95%CI 1.53-2.22). Use of moderate or high 5-HT1A affinity of β-adrenoceptor antagonists was associated with an increased ROR of nightmares compared with low 5-HT1A affinity of β-adrenoceptor antagonists (aROR moderate vs. low 1.22, 95%CI 1.04-1.43 and aROR high vs. low 2.46, 95%CI 1.93-3.13).
Conclusion: In our large pharmacovigilance study, nightmares are more frequently reported for pindolol and metoprolol, and among β-adrenoceptor antagonists with high lipid solubility and high 5-HT1A receptor affinity.