Comparação da efetividade entre o zolpidem e a trazodona no tratamento da insônia em idosos: uma revisão sistemática

Abstract

INTRODUCTION: Insomnia is a highly prevalent sleep disorder among older adults, affecting approximately 58.6% of this population. The condition is associated with age, comorbidities, and factors such as female sex. In addition to negatively impacting quality of life, insomnia is also linked to the worsening of psychiatric conditions. Treatments include non-pharmacological interventions, such as behavioral therapies, and pharmacological approaches, particularly zolpidem and trazodone. The use of zolpidem may lead to adverse events such as excessive drowsiness and increased risk of falls. Trazodone, an antidepressant with sedative effects, presents a lower risk of dependence but may cause gastrointestinal side effects and hypotension. Both drugs are used in the management of insomnia in older adults; however, there is no well-established clinical evidence directly comparing their efficacy and safety in this population. OBJECTIVES: To evaluate the efficacy and safety of zolpidem hemitartrate and trazodone in the treatment of insomnia in older adults, as well as to analyze the impact of behavioral therapies alone or combined with pharmacological treatments. METHOD: A systematic review registered on the OSF platform was conducted following PRISMA criteria. The PICO strategy defined the population as adults and older adults with insomnia, the intervention as zolpidem, the comparison as trazodone, and the outcome as insomnia remission. Searches were performed in databases such as PubMed, Cochrane, BVS, and Clinical Queries using MESH and DECS terms. Only randomized clinical trials published in English, Portuguese, and Spanish were included, with no year restriction. Studies involving patients with insomnia (≥18 years) treated with zolpidem, trazodone, or behavioral therapies (BT and/or CT) were evaluated regarding insomnia remission and adverse effects. Risk of bias was assessed using the RoB 2 tool, and evidence quality was evaluated using GRADE. Two studies were included after screening 87 studies. The analysis indicated positive synergism between combined therapies (psychological or pharmacological), especially BT+CT and zolpidem+trazodone. Improvements were observed in insomnia, daytime functioning, anxiety, and depression, particularly in patients with psychiatric comorbidities. RESULTS: Both studies demonstrated that treatment with zolpidem and trazodone, either alone or combined with behavioral therapies, significantly improved insomnia remission. No statistical difference was found between BT (behavioral therapy) and zolpidem as monotherapies. However, the combinations BT+zolpidem and zolpidem+trazodone increased remission rates. Therapies within the same modality (BT+CT [cognitive therapy] or zolpidem+trazodone) showed better outcomes. BT was more effective in reducing anxiety, while zolpidem showed a more immediate effect on fatigue and daytime functioning. Trazodone stood out in patients with insomnia associated with depression. The most frequently reported adverse effects were drowsiness and hypotension with trazodone, and tolerance and dependence with zolpidem. DISCUSSION AND CONCLUSIONS: The combination of behavioral or pharmacological therapies showed greater efficacy in insomnia remission compared with monotherapies. Zolpidem hemitartrate was more effective for sleep initiation but presented a higher risk of dependence and adverse drug reactions. Trazodone showed favorable results in patients with depressive symptoms, with a lower risk of dependence. Treatment choice should consider comorbidities, adverse effects, and patient preferences.