![]() Among 2245 elderly suicide decedents in Europe, toxicology panels identified benzodiazepines as the means of suicide in about half of poisoning deaths. The literature suggests a possible association between insomnia medications and suicidal ideation and behavior. 9 Yet, little is known about the comparative safety of these agents. Some insomnia agents carry warning labels for risk of adverse events of suicide risk (Table 1). Similarly, in the Department of Veterans Health Affairs (VA), the national formulary identifies zolpidem as the preferred agent for insomnia, yet high fill volumes of inexpensive sedating antihistamines and older antidepressants at sub-therapeutic doses for depression (i.e., trazodone = < 200 mg) suggest routine off-label use for insomnia. The 2017 American Academy of Sleep Medicine (AASM) guidelines for the pharmacological treatment of chronic insomnia in adults recognized that trazodone and other off-label medications are commonly prescribed despite poor evidence. Off-label medications include antihistamines and trazodone, a serotonin reuptake inhibitor/agonist. 6, 7, 8 Agents approved by the Food and Drug Administration (FDA) for the treatment of insomnia include benzodiazepines, benzodiazepine receptor agonists, ramelteon, and suvorexant. 4, 5 Persistent insomnia is associated with increased suicide risk and is a modifiable risk factor. These findings provide the first comparative effectiveness evidence against the use of trazodone for insomnia.Īs many as 10% of US adults meet diagnostic criteria for insomnia 1, 2, 3 and about one-third have difficulty falling or staying asleep. No significant differences in suicide attempt risk were identified between benzodiazepines or sedating antihistamines and zolpidem, respectively. Conclusions and RelevanceĬompared to zolpidem, hazard of suicide attempt was 61% higher with trazodone (< 200 mg). After adjusting for days’ supply, mental health history, and pain and central nervous system medication history, hazard ratios (compared to zolpidem) were as follows: (< 200 mg) trazodone (HR = 1.61, 95% CI 1.07–2.43) sedating antihistamines (HR = 1.37, 95% CI 0.90–2.07) and benzodiazepines (HR = 1.31, 95% CI 0.85–2.08). Three hundred forty-eight thousand four hundred forty-nine subjects met criteria and three well-balanced cohorts by drug class matched to zolpidem were created. Suicide attempts within 12 months of first exposure. Subjects with insomnia polypharmacy or cross-overs in the 12 months following first exposure were excluded. Exposure was defined as an incident monotherapy exposure preceded by 12 months without any insomnia medications. Agents accounting for at least 1% of total insomnia fill volume were < 200 mg trazodone, hydroxyzine, diphenhydramine, zolpidem, lorazepam, diazepam, and temazepam. VA formularies and data were used to identify prescriptions for insomnia. VA patients without any history of suicidal ideation or behavior 12 months prior to first exposure. DesignĬomparative effectiveness using propensity score-matched samples. To assess the comparative effectiveness of the safety of medications routinely used to treat insomnia in VA. Yet little is known about the comparative safety of these agents with regard to suicidal behavior. ![]() The Department of Veterans Health Affairs (VA) fills high volumes of inexpensive, over-the-counter sedating antihistamines and older antidepressants in addition to benzodiazepines and zolpidem. Guidelines for the pharmacological treatment of chronic insomnia in adults recognize that trazodone and other off-label medications are commonly prescribed despite poor evidence. ![]()
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