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• W3129125951 abstract "Free AccessLetters to the EditorResponse to: Real effect vs placebo effect Alexandros N. Vgontzas, MD, Kristina Puzino, PhD, Julio Fernandez-Mendoza, PhD Alexandros N. Vgontzas, MD Address correspondence to: Alexandros N. Vgontzas, MD, Penn State University College of Medicine, Department of Psychiatry, 500 University Drive, Hershey, PA 17033; Tel: (717) 531-7278; Fax: (717) 531-6491; Email: E-mail Address: [email protected] Search for more papers by this author , Kristina Puzino, PhD Search for more papers by this author , Julio Fernandez-Mendoza, PhD Search for more papers by this author Published Online:May 1, 2021https://doi.org/10.5664/jcsm.9130SectionsAbstractPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTCitation:Vgontzas AN, Puzino K, Fernandez-Mendoza J. Response to: Real effect vs placebo effect. J Clin Sleep Med. 2021;17(5):1143–1144.INTRODUCTIONWe thank Dr. Hunasikatti for his commentary1 on our study titled “Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study.”2 Trazodone, a heterocyclic antidepressant in low doses of 25 to 150 mg, has been the second most widely prescribed medication for sleep for the last 20 years in the United States.3 In fact, a recent study showed that trazodone has been prescribed in increasing trends in the last 10 years.4 Only in 2018, there were 24,000,000 prescriptions for low-dose trazodone in U.S. adults.4 Hence, the following question arises: Why do so many physicians and patients use this medication although it is not approved by the U.S. Food & Drug Administration, not recommended by scientific organizations, and not promoted by industry? A critical issue is that trazodone, despite its widespread use by the U.S. public as prescribed off-label by their physicians, has remained grossly understudied in randomized clinical trials (RCTs) for insomnia; thus, trazodone lacks evidence from RCTs.5 This concern was one of our motives to initiate this small pilot study.The lack of evidence and guideline indication for trazodone did not stop Morin and colleagues6 from investigating its therapeutic effect as a second-stage agent in a sequential RCT with hundreds of patients. Interestingly, their large RCT showed that cognitive-behavioral therapy for insomnia was most effective in reducing sleep latency and wake time after sleep onset and in increasing sleep efficiency, whereas medications had their strongest effect on increasing total sleep time, particularly when patients were switched from zolpidem to trazodone.6 The investigators concluded that “[G]iven the emerging literature on insomnia phenotypes and the higher risk for cardiovascular morbidity among individuals with insomnia and short sleep duration, such findings could guide the development of personalized therapies for insomnia management.”6In summary, we would agree with Dr. Hunasikatti’s concern1 about the use of trazodone in our small pilot study if our sample had comprised at-risk individuals for whom trazodone contraindications existed; with this not being the case, “lack of evidence” arising from multiple reasons and sources, including physicians’ preferences or industry interest, should never stop scientific inquiry. Leaving trazodone underinvestigated, despite promising results, and grossly prescribed should be a matter of public health concern for the National Institutes of Health and the U.S. Food & Drug Administration.Insomnia with objective short sleep duration was proposed by our group as a novel phenotype associated with activation of the stress system, particularly the hypothalamic-pituitary-adrenal axis, significant cardiometabolic and neurocognitive morbidity, and, possibly, better response to biologic treatments.7 Comparing the effectiveness of a pharmacologic agent that seemed to decrease the activation of the hypothalamic-pituitary-adrenal axis and increase total sleep time with that of cognitive-behavioral therapy for insomnia, the first-line recommended treatment, was one of the goals of our preliminary study. Our results are interesting but far from conclusive, as indicated in the title of our report. Notably, 4 studies consisting of retrospective secondary analyses of previously published RCTs have found lower insomnia remission rates after cognitive-behavioral therapy for insomnia in the insomnia with objective short sleep duration phenotype than in the insomnia with normal sleep duration phenotype,8–11 and 3 other studies have found equivalent insomnia remission rates in these 2 phenotypes.12–14 Similarly, despite this preliminary evidence, the issue of the relative efficacy of cognitive-behavioral therapy for insomnia in our proposed insomnia phenotypes remains inconclusive but should fuel scientific inquiry for well-designed, adequately powered, prospective RCTs using a personalized medicine, phenotype-matching approach.Dr. Hunasikatti1 also noted our choice of measure and cutoff point for total sleep time when classifying the insomnia with objective short sleep duration phenotype. The answer is clearly indicated in the “Methods” section of the article and discussed in the following manner:In this study, we used the cut-off of less than 7 hours via actigraphy, which was the closest meaningful cut-off to the median of 6.8 hours. This is higher than the cut-off of 6 hours, which was the median PSG sleep duration in physiological studies and in large random general population samples. It is to be expected that the median value of TST will differ based on the method used (i.e., actigraphy tends to overestimate TST when compared to PSG), population studied (i.e., general random sample versus clinical or volunteer), and age of the sample. We have emphasized that the previously suggested cut-off of 6 hours for the ISS phenotype has been used as an internally valid marker of the severity of insomnia and not as a recommended optimal sleep duration for the general population.2These statements and approach should have resolved any concerns and is consistent with our early proposal that an important research agenda for insomnia phenotyping was to “replace the expensive, inconvenient, and impractical in-lab sleep measures with easy-to-use, inexpensive, home-based objective sleep measures.”7 Future studies should validate actigraphy and other wearable technology, not just to accurately estimate specific polysomnography parameters as has been traditionally done but also to provide reliability and validity for specific cutoff points needed to identify individuals who are short sleepers despite adequate opportunity for sleep and, thus, individuals with the insomnia with objective short sleep duration phenotype.The results of our small pilot study are interesting, obviously stimulating, but far from conclusive. We cannot agree more with the final statement by Wong and colleagues4 in their Journal of the American Medical Association article that “[M]ore studies evaluating the efficacy and safety of trazodone for insomnia are warranted” and with the conclusive statements by Morin and colleagues6 in their Journal of the American Medical Association Psychiatry article: “Additional studies are needed to validate best treatment algorithms for insomnia disorder, and rather than randomizing patients to treatment options, perhaps a more effective strategy would involve a personalized approach matching patients with their preferred treatment, while also taking into account their insomnia phenotypes (ie, presence of hyperarousal and TST).”DISCLOSURE STATEMENTAll authors have seen and approved the manuscript. The authors report no conflicts of interest.REFERENCES1. Hunasikatti M. Real effect vs placebo effect. J Clin Sleep Med. 2021;17(5):1141. https://doi.org/ DOI: https://doi.org/10.5664/jcsm.9092 CrossrefGoogle Scholar2. Vgontzas AN, Puzino K, Fernandez-Mendoza J, Krishnamurthy VB, Basta M, Bixler EO. Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study. J Clin Sleep Med. 2020;16(12):2009–2019. https://doi.org/10.5664/jcsm.8740 LinkGoogle Scholar3. Bertisch SM, Herzig SJ, Winkelman JW, Buettner C. National use of prescription medications for insomnia: NHANES 1999-2010. Sleep. 2014;37(2):343–349. https://doi.org/10.5665/sleep.3410 CrossrefGoogle Scholar4. Wong J, Murray Horwitz M, Bertisch SM, Herzig SJ, Buysse DJ, Toh S. Trends in dispensing of zolpidem and low-dose trazodone among commercially insured adults in the United States, 2011-2018. JAMA. 2020;324(21):2211–2213. https://doi.org/10.1001/jama.2020.19224 CrossrefGoogle Scholar5. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(2):307–349. https://doi.org/10.5664/jcsm.6470 LinkGoogle Scholar6. Morin CM, Edinger JD, Beaulieu-Bonneau S, et al.. Effectiveness of sequential psychological and medication therapies for insomnia disorder: a randomized clinical trial. JAMA Psychiatry. 2020;77(11):1107–1115. https://doi.org/10.1001/jamapsychiatry.2020.1767 CrossrefGoogle Scholar7. Vgontzas AN, Fernandez-Mendoza J, Liao D, Bixler EO. Insomnia with objective short sleep duration: the most biologically severe phenotype of the disorder. Sleep Med Rev.2013;17(4):241-254. https://doi.org/10.1016/j.smrv.2012.09.005 Google Scholar8. Troxel WM, Conrad TS, Germain A, Buysse DJ. Predictors of treatment response to brief behavioral treatment of insomnia (BBTI) in older adults. J Clin Sleep Med. 2013;9(12):1281–1289. https://doi.org/10.5664/jcsm.3270 LinkGoogle Scholar9. Bathgate CJ, Edinger JD, Krystal AD. Insomnia patients with objective short sleep duration have a blunted response to cognitive behavioral therapy for insomnia. Sleep. 2017;40(1):zsw012. Google Scholar10. Rochefort A, Jarrin DC, Bélanger L, Ivers H, Morin CM. Insomnia treatment response as a function of objectively measured sleep duration. Sleep Med. 2019;56:135–144. https://doi.org/10.1016/j.sleep.2019.01.016 CrossrefGoogle Scholar11. Kalmbach DA, Cheng P, Roth T, Sagong C, Drake CL. Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women. Sleep Med. 2020;73:82–92. https://doi.org/10.1016/j.sleep.2020.04.024 CrossrefGoogle Scholar12. Lovato N, Lack L, Kennaway DJ. Comparing and contrasting therapeutic effects of cognitive-behavior therapy for older adults suffering from insomnia with short and long objective sleep duration. Sleep Med. 2016;22:4–12. https://doi.org/10.1016/j.sleep.2016.04.001 CrossrefGoogle Scholar13. Miller CB, Espie CA, Bartlett DJ, Marshall NS, Gordon CJ, Grunstein RR. Acceptability, tolerability, and potential efficacy of cognitive behavioural therapy for insomnia disorder subtypes defined by polysomnography: a retrospective cohort study. Sci Rep. 2018;8(1):6664. https://doi.org/10.1038/s41598-018-25033-3 CrossrefGoogle Scholar14. Crönlein T, Wetter TC, Rupprecht R, Spiegelhalder K. Cognitive behavioral treatment for insomnia is equally effective in insomnia patients with objective short and normal sleep duration. Sleep Med. 2020;66:271–275. https://doi.org/10.1016/j.sleep.2018.10.038 CrossrefGoogle Scholar Previous article Next article FiguresReferencesRelatedDetails Volume 17 • Issue 5 • May 1, 2021ISSN (print): 1550-9389ISSN (online): 1550-9397Frequency: Monthly Metrics History Submitted for publicationJanuary 20, 2021Submitted in final revised formJanuary 20, 2021Accepted for publicationJanuary 20, 2021Published onlineMay 1, 2021 Information© 2021 American Academy of Sleep Medicine" @default.
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