Real-World Characteristics and Treatment Patterns of Patients With Insomnia Prescribed Trazodone in the United States

Pochiero, Ilena; Gorini, Manuela; Comandini, Alessandro; Calisti, Fabrizio; Loreto, Giorgio Di; Cattaneo, A.; Knight, Tyler; Anastassopoulos, Kathryn; Patel, Reema; Baik, Rebecca; Bruni, Oliviero

doi:10.1016/j.clinthera.2022.07.004

Cited by 7 publications

(5 citation statements)

References 27 publications

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“…In this context, trazodone, because of it multimodal action, represents a clear resource. A recent study involving 5.8 million patients with insomnia in the United States demonstrated that trazodone use was widespread; a substantial proportion of patients with insomnia treated with trazodone also had diagnoses of anxiety and depression [106]. In this study, the median initial daily dose for adults remained constant at 50 mg.…”

Section: When Depression Gets Old: Unmet Needs Of Depression In the E...mentioning

confidence: 75%

Treating Depression in Clinical Practice: New Insights on the Multidisciplinary Use of Tradozone

Albert¹,

Tomasetti²,

Marra³

et al. 2023

Preprint

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Depression is estimated to be a leading contributor to the global mental health-related burden. The determinants of this huge prevalence lie in the fact that depressive symptoms may be comorbid in a wide variety of disorders, thus complicating and exacerbating their clinical pictures. This makes the treatment of depressive symptoms even more difficult since many pharmacological and pharmacokinetic interactions should be considered by physicians approaching the therapy. Hence, depression still represents a challenge for both psychiatrists and the other clinicians, in terms of its high rates of relapse and resistance despite well-established protocols. It is also complicated by the well-known latency in its complete response to current antidepressant treatments. In this context, the search for new strategies in antidepressant treatment is mandatory; even including revising the use of “old” pharmacotherapies by considering their specific features may help to perfecting the treatment of depression, both in its standalone psychiatric manifestation and in the framework of other clinical conditions. The results of a consensus of experts regarding the possible use of trazodone as a valuable strategy for addressing the “real world” unmet needs of depression treatment is herein reported. This is based on the unique characteristics of this drug possibly delivering a rapid antidepressant action as compared to other selective serotonin reuptake inhibitors (SSRIs) as well as on its pharmacodynamic malleability and pharmacokinetic tolerability when used in the milieu of other drugs in treating comorbid depressive symptoms.

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Section: When Depression Gets Old: Unmet Needs Of Depression In the E...mentioning

confidence: 75%

Treating Depression in Clinical Practice: New Insights on the Multidisciplinary Use of Tradozone

Albert¹,

Tomasetti²,

Marra³

et al. 2023

Preprint

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“…As for "off-label use", it can be defined as "the prescription of an authorized medication for a use not described in the Summary of Product Characteristics (SPC)", and according to data available in the literature, PDs are increasingly used in this way in the field of psychiatry, especially antipsychotics, which have been widely used in the treatment of depression disorders [47,48]. Another example of off-label treatment is the use of antidepressant drugs in the treatment of sleep disorders, such as trazodone [49].…”

Section: Discussionmentioning

confidence: 99%

Exploring Adverse Drug Reactions in Psychotropic Medications: A Retrospective Analysis of Portuguese Pharmacovigilance Data

Bandarra,

Costa,

Angelova

et al. 2024

Healthcare

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Psychotropic drugs (PDs) include anxiolytics, sedatives and hypnotics, antidepressants, and antipsychotics, and they are available as medicines with different safety profiles. Given Portugal’s high anxiolytic consumption and the rising prevalence of mental disorders, safety monitoring is crucial. This study aimed to analyze the individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) related to PDs, obtained through spontaneous reporting, and recorded in the Portuguese National Pharmacovigilance System between January 2017 and December 2021. This observational and retrospective study analyzed the ICSRs of suspected ADRs to PDs. Most reports pertained to female individuals (67.78%) between 18 and 64 years of age (63.71%). The pharmaceutical industry was the primary source of these reports (62.16%). Antidepressants were responsible for most ICSRs (61.90%). At least one serious ADR was recorded in 58.44% of the reports, and 43.84% of ADRs evolved into “cure”. The most-observed ADRs were nausea (10.92%), dizziness (10.70%), and off-label use (10.30%). In the causality assessment, 45.49% of ADRs were classified as “possible”, and only 4.96% were classified as “definitive”. The current analysis helps to strengthen the safety evidence for PDs. In the future, some measures could be implemented to improve the use of and/or access to PDs, as well as to reinforce the rate of suspected ADR reports within the community, contributing to the safety data available.

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“…The use of trazodone to treat sleep alterations, especially in patients with psychiatric comorbidities, is a widespread strategy [ 72 , 73 ] that yielded beneficial effects in MDD patients [ 35 , 74 ] as well as on certain sleep measures and post-withdrawal insomnia in subjects with AUD [ 12 , 75 , 76 ]. Given that adding trazodone to first-line treatments for insomnia increased rates of remission in non-responding subjects [ 77 ] and the detrimental impact of sleep disruptions on the course of both MDD and AUD, the compound could represent a useful option to effectively address these features in comorbid patients.…”

Section: Discussionmentioning

confidence: 99%

Update on Pharmacological Treatment for Comorbid Major Depressive and Alcohol Use Disorders: The Role of Extended-release Trazodone

Nicola

Pepe

Panaccione

et al. 2023

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Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD) are major public health concerns because of their high prevalence and clinical and functional severity. MDD and AUD commonly co-occur, but effective therapeutic approaches for comorbidity are still scarce. Available evidence on selective serotonin reuptake inhibitors and tricyclic antidepressants held mixed results, and further pharmacological categories have been less investigated. Trazodone is an approved antidepressant drug for adults and has shown efficacy on symptoms like anxiety and insomnia ob- served in AUD patients as well. Thus, this study aims to evaluate the effect of extended-release trazo- done on clinical and functional features in MDD + AUD subjects. Methods: One hundred MDD + AUD outpatients were retrospectively evaluated at 1, 3, and 6 months of treatment with extended-release trazodone (150-300 mg/day, flexibly dosed). Improvement in de- pressive symptoms was the primary outcome measure. Changes in anxiety, sleep, functioning, quality of life, clinical global severity, and alcohol craving were also investigated. Results: Trazodone reduced depressive symptoms (p < 0.001) with 54.5% remission at the endpoint. Similar improvements were observed in all secondary outcomes, including anxiety, sleep alterations, and craving (p < 0.001). Only mild side effects were reported and disappeared over time. Conclusion: Extended-release trazodone displayed good antidepressant properties in MDD + AUD patients, ameliorating overall symptomatology, functioning, and quality of life, with a good safety/ tolerability profile. Further, it significantly improved sleep disturbances and craving symptoms, which are associated with drinking relapse and worse outcomes. Therefore, trazodone might represent a promising pharmacological option for MDD + AUD patients.

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Real-World Characteristics and Treatment Patterns of Patients With Insomnia Prescribed Trazodone in the United States

Cited by 7 publications

References 27 publications

Treating Depression in Clinical Practice: New Insights on the Multidisciplinary Use of Tradozone

Treating Depression in Clinical Practice: New Insights on the Multidisciplinary Use of Tradozone

Exploring Adverse Drug Reactions in Psychotropic Medications: A Retrospective Analysis of Portuguese Pharmacovigilance Data

Update on Pharmacological Treatment for Comorbid Major Depressive and Alcohol Use Disorders: The Role of Extended-release Trazodone

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