Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia

Krystal, Andrew D.; Durrence, H. Heith; Scharf, Martin B.; Jochelson, Philip; Rogowski, Roberta; Ludington, Elizabeth; Roth, Thomas

doi:10.1093/sleep/33.11.1553

Cited by 162 publications

(134 citation statements)

References 29 publications

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“…15 Costs and cost-savings linked to medication are complicated by the inconsistent duration of medication use in clinical trials, even more so in the real world. A brief review of the literature found duration of clinical trials of sedative hypnotics range from short (2 weeks 16,17 ) to moderate (1-3 months [18][19][20] ) to long (6 months 15 ).…”

Section: S C I E N T I F I C I N V E S T I G a T I O N Smentioning

confidence: 99%

Impact of Brief Cognitive Behavioral Treatment for Insomnia on Health Care Utilization and Costs

McCrae

Bramoweth

Williams

et al. 2014

Journal of Clinical Sleep Medicine

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Study Objectives: To examine health care utilization (HCU) and costs following brief cognitive behavioral treatment for insomnia (bCBTi). Methods: Reviewed medical records of 84 outpatients [mean age = 54.25 years (19.08); 58% women] treated in a behavioral sleep medicine clinic (2005)(2006)(2007)(2008)(2009)(2010) based in an accredited sleep disorders center. Six indicators of HCU and costs were obtained: estimated total and outpatient costs, estimated primary care visits, CPT costs, number of office visits, and number of medications. All patients completed ≥ 1 session of bCBTi. Those who attended ≥ 3 sessions were considered completers (n = 37), and completers with significant sleep improvements were considered responders (n = 32). Results: For completers and responders, all HCU and cost variables, except number of medications, signifi cantly decreased (ps < 0.05) or trended towards decrease at posttreatment. Completers had average decreases in CPT costs of $200 and estimated total costs of $75. Responders had average decreases in CPT costs of $210. No signifi cant decreases occurred for non-completers. Conclusions: bCBTi can reduce HCU and costs. Response to bCBTi resulted in greater reduction of HCU and costs. While limited by small sample size and non-normal data distribution, the fi ndings highlight the need for greater dissemination of bCBTi for several reasons: a high percentage of completers responded to treatment, as few as 3 sessions can result in signifi cant improvements in insomnia severity, bCBTi can be delivered by novice clinicians, and health care costs can reduce following treatment. Insomnia remains an undertreated disorder, and brief behavioral treatments can help to increase access to care and reduce the burden of insomnia. Keywords: Insomnia, health care utilization, costs, brief cognitive behavioral treatment, physician visits, medication Citation: McCrae CS; Bramoweth AD; Williams J; Roth A; Mosti C. Impact of brief cognitive behavioral treatment for insomnia on health care utilization and costs. J Clin Sleep Med 2014;10(2):127-135.http://dx.doi.org/10.5664/jcsm.3436 S C I E N T I F I C I N V E S T I G A T I O N SC hronic insomnia impacts approximately 8% to 10% of adults in the United States population 1 and carries substantial economic burden. Direct costs (i.e., costs directly related to treatment) have been estimated at $13.9 billion annually in the United States, with total treatment costs estimated at $77 to $92 billion. 2 When indirect costs (i.e., lost productivity, insomniarelated accidents, increased medical problems) are included, annual costs exceed $100 billion. 3 Evidence from outside the U.S. reveals a similar pattern. Specifi cally, a study in Quebec, Canada, found that the combined direct and indirect per-person costs of insomnia syndrome (insomnia complaint ≥ 3 nights/ week with > 1 month duration, dissatisfaction with sleep, and daytime impairment; prescription sleep medication ≥ 3 nights/ week) was approximately $5,010; with $293 attributed to direct costs and $4,717...

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Section: S C I E N T I F I C I N V E S T I G a T I O N Smentioning

confidence: 99%

Impact of Brief Cognitive Behavioral Treatment for Insomnia on Health Care Utilization and Costs

McCrae

Bramoweth

Williams

et al. 2014

Journal of Clinical Sleep Medicine

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“…In the 3-month clinical trial, the 3 mg dose produces significant improvement in sleep latency without evidence of next-day residual sedation [27] . In elderly patients, the 4-week study of 6 mg doxepin significantly improved total sleep time and sleep quality versus placebo and these improvements were sustained throughout the trial [25] .…”

Section: Low Dose Doxepin For Insomniamentioning

confidence: 99%

“…Doxepin should be avoided in patients who take anti-depresants, alcohol and sedating antihistaminic. Doxepin is metabolized by CYP isoenzymes, co-administration of cimetidine and sertraline like CYP inhibitors may increase the plasma concentration of doxepin [19,[25][26][27][28][29][30] .…”

Section: Tolerabilitymentioning

confidence: 99%

“…Third, there is no report of weight gaining or appetite increasing. The most common adverse reactions reported were sedation, somnolence, nausea and upper respiratory tract infection [19,[25][26][27][28][29][30] . During the clinical trial, there is no report for rebound insomnia/withdrawal syndrome after doxepin discontinuation.…”

Section: Safetymentioning

confidence: 99%

“…During the clinical trial, there is no report for rebound insomnia/withdrawal syndrome after doxepin discontinuation. Thus doxepin does not produce physical dependence [19,[25][26][27][28][29][30] . Cardiac safety study showed no prolongation of QT interval with 50 mg dose of doxepin [31] .…”

Section: Safetymentioning

confidence: 99%

See 2 more Smart Citations

Therapeutic rationale for low dose doxepin in insomnia patients

Katwala

Kumar

Sejpal

et al. 2013

Asian Pacific Journal of Tropical Disease

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Antidepressants for insomnia in adults

Everitt

Baldwin

Stuart

et al. 2018

Cochrane Database of Systematic Reviews

105

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We identified relatively few, mostly small studies with short-term follow-up and design limitations. The effects of SSRIs compared with placebo are uncertain with too few studies to draw clear conclusions. There may be a small improvement in sleep quality with short-term use of low-dose doxepin and trazodone compared with placebo. The tolerability and safety of antidepressants for insomnia is uncertain due to limited reporting of adverse events. There was no evidence for amitriptyline (despite common use in clinical practice) or for long-term antidepressant use for insomnia. High-quality trials of antidepressants for insomnia are needed.

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Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia

Cited by 162 publications

References 29 publications

Impact of Brief Cognitive Behavioral Treatment for Insomnia on Health Care Utilization and Costs

Impact of Brief Cognitive Behavioral Treatment for Insomnia on Health Care Utilization and Costs

Therapeutic rationale for low dose doxepin in insomnia patients

Antidepressants for insomnia in adults

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