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A Comparison of Nefazodone and Fluoxetine on Mood and on Objective, Subjective, and Clinician-Rated Measures of Sleep in Depressed Patients: A Double-Blind, 8-Week Clinical Trial
Abstract
Background Previous small trials have suggested that nefazodone does not suppress rapid-eye-movement (REM) sleep or increase REM latency in depressed patients, in contrast to fluoxetine. The effects of nefazodone and fluoxetine on sleep architecture and on clinician- and patient-rated sleep measures were directly compared in this 8-week, multicenter, double-blind, randomized, parallel-group study. Method Forty-four outpatients with moderate to severe, nonpsychotic major depressive disorder (DSM-III-R) and insomnia were randomly assigned to receive nefazodone (Days 1-7, 200 mg/day; Days 8-56, 400 mg/day) or fluoxetine (Days 1-56, 20 mg/day). Sleep measures were obtained at baseline, while patients were unmedicated, and at Weeks 2, 4, and 8 of treatment. Results In 43 evaluable patients (23 nefazodone, 20 fluoxetine), nefazodone and fluoxetine demonstrated similar antidepressant efficacy. All significant values were p Conclusion While nefazodone and fluoxetine showed equivalent antidepressant efficacy, more objective, subjective, and clinician-rated measures of sleep disturbance were improved during treatment with nefazodone than with fluoxetine. These results suggest that antidepressant effects of medications can occur independently of drug-induced changes in objective, subjective, and clinician-rated measures of sleep. Further studies, including parallel placebo-controlled comparisons with nefazodone, are needed to further test this hypothesis.
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In RCTs, prolonged sleep latency and reduced sleep time have been noted with sertraline, fluoxetine, fluvoxamine and paroxetine, particularly when compared to placebo and against sedative TCAs.
“In RCTs, prolonged sleep latency and reduced sleep time have been noted with sertraline (Jindal et al., 2003), fluoxetine (Gillin et al., 1997), fluvoxamine (Wilson et al., 2000) and paroxetine (Hicks et al., 2002), particularly when compared to placebo and against the sedative TCAs.”
From Antidepressants and their effect on sleep (2005) · cites this paper as Gillin et al., 1997
Patients receiving nefazodone demonstrated increased sleep efficiency, while patients on fluoxetine demonstrated a significant reduction in sleep efficiency and a significant increase in number of awakenings compared to baseline scores.
“With respect to sleep parameters, patients receiving nefazodone demonstrated increased sleep efficiency, while patients on fluoxetine demonstrated a significant reduction in sleep efficiency and a significant increase in number of awakenings compared to baseline scores [Gillin et al., 1997].”
From Depression, sleep physiology, and antidepressant drugs (2001) · cites this paper as Gillin et al., 1997
In the comparative nefazodone-fluoxetine sleep study, there was an increase in total REM sleep time in patients receiving nefazodone in contrast to the expected REM suppression associated with fluoxetine.
“With respect to REM sleep physiology, the comparative nefazodonefluoxetine sleep study demonstrated an increase in total REM sleep time in patients receiving nefazodone in contrast to the expected REM suppression associated with”
From Depression, sleep physiology, and antidepressant drugs (2001) · cites this paper as Gillin et al., 1997
Nefazodone exerts minimal effects in altering sleep continuity measures; it either decreases awake and movement time and number of awakenings, increases sleep efficiency, or has no effect on these parameters, thus preserving sleep continuity.
“First, nefazodone exerts minimal effects in altering sleep continuity measures.In this regard, nefazodone either decreases awake and movement time and number of awakenings, increases sleep efficiency, or has no effect on these parameters, thus preserving sleep continuity [Armitage et al., 1994[Armitage et al., , 1997;;Gillin et al., 1997;Sharpley et al., 1992Sharpley et al., , 1996;;Rush et al., 1”
From Depression, sleep physiology, and antidepressant drugs (2001) · cites this paper as Gillin et al., 1997
In recent studies comparing nefazodone and fluoxetine in 125 patients with major depression, clinical efficacy was comparable for both groups.
“Recent studies compared the effects of nefazodone and fluoxetine on sleep parameters in 125 patients with major depression [Gillin et al., 1997;Armitage et al., 1997;Rush et al., 1998].Standard dosing regimen were employed for both drugs in these studies.Clinical efficacy was comparable for both groups.”
From Depression, sleep physiology, and antidepressant drugs (2001) · cites this paper as Gillin et al., 1997
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Saad, M. (2019) · uO Research (University of Ottawa) · doi:10.20381/ruor-23661
Berry, R. B., & Wagner, M. H. (2014) · Elsevier eBooks · doi:10.1016/b978-1-4557-7051-9.00041-3
Metadata
- Authors
- Gillin, J. C., Rapaport, M., Erman, M. K., Winokur, A., & Albala, B. J.
- Affiliations
- University of California San Diego (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 1997-05-15
- Volume
- 58
- Issue
- 5
- Pages
- 185-192
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2046170940
- Cited by
- 104
- References
- 0
- Citations by year
- 2025: 1 · 2024: 1 · 2020: 3 · 2019: 2 · 2018: 1 · 2017: 1 · 2016: 7 · 2014: 4 · 2013: 3 · 2012: 2
- FWCI
- 9.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (5-P50-MH30914-19, P50MH030914)
- National Center for Research Resources (M01RR000827)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Life Sciences › Neuroscience › Cognitive Neuroscience › Sleep and Wakefulness Research
- Keywords
- nefazodone, fluoxetine, major depressive disorder, insomnia, sleep architecture, REM sleep, REM latency, sleep efficiency, awakening, antidepressant efficacy, sleep disorders, objective sleep measures, subjective sleep measures
- MeSH terms
- Adult, Affect, Ambulatory Care, Depressive Disorder, Double-Blind Method, Female, Fluoxetine, Humans, Male, Middle Aged, Personality Inventory, Piperazines, Placebos, Psychiatric Status Rating Scales, Sleep, Sleep Wake Disorders, Triazoles, Treatment Outcome, Polysomnography, Antidepressive Agents, Second-Generation
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