Efficacy and safety of doxepin 6mg in a four-week outpatient trial of elderly adults with chronic primary insomnia

Lankford, Alan; Rogowski, Roberta; Essink, Beal; Ludington, Elizabeth; Durrence, H. Heith; Roth, Thomas

doi:10.1016/j.sleep.2011.09.006

Cited by 77 publications

(77 citation statements)

References 12 publications

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“…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] . Clinical trial in transient insomnia patients (n=565) also demonstrated the effectiveness of doxepin 6 mg in sleep onset, sleep maintenance, sleep duration and sleep quality [28] .…”

Section: Low Dose Doxepin For Insomniamentioning

confidence: 93%

“…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%

“…Low doses doxepin 3 mg and 6 mg have several distinctive advantages over other available hypnotic agents for several reasons [19,[25][26][27][28][29][30] .…”

Section: Benefits Of Low Dose Doxepin Therapy For Insomniamentioning

confidence: 99%

See 4 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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Section: Low Dose Doxepin For Insomniamentioning

confidence: 93%

Section: Tolerabilitymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

“…Low doses doxepin 3 mg and 6 mg have several distinctive advantages over other available hypnotic agents for several reasons [19,[25][26][27][28][29][30] .…”

Section: Benefits Of Low Dose Doxepin Therapy For Insomniamentioning

confidence: 99%

See 3 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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Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Lai,

Ge,

Sun

et al. 2024

JAMA Netw Open

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ImportanceLarge language models (LLMs) may facilitate the labor-intensive process of systematic reviews. However, the exact methods and reliability remain uncertain.ObjectiveTo explore the feasibility and reliability of using LLMs to assess risk of bias (ROB) in randomized clinical trials (RCTs).Design, Setting, and ParticipantsA survey study was conducted between August 10, 2023, and October 30, 2023. Thirty RCTs were selected from published systematic reviews.Main Outcomes and MeasuresA structured prompt was developed to guide ChatGPT (LLM 1) and Claude (LLM 2) in assessing the ROB in these RCTs using a modified version of the Cochrane ROB tool developed by the CLARITY group at McMaster University. Each RCT was assessed twice by both models, and the results were documented. The results were compared with an assessment by 3 experts, which was considered a criterion standard. Correct assessment rates, sensitivity, specificity, and F1 scores were calculated to reflect accuracy, both overall and for each domain of the Cochrane ROB tool; consistent assessment rates and Cohen κ were calculated to gauge consistency; and assessment time was calculated to measure efficiency. Performance between the 2 models was compared using risk differences.ResultsBoth models demonstrated high correct assessment rates. LLM 1 reached a mean correct assessment rate of 84.5% (95% CI, 81.5%-87.3%), and LLM 2 reached a significantly higher rate of 89.5% (95% CI, 87.0%-91.8%). The risk difference between the 2 models was 0.05 (95% CI, 0.01-0.09). In most domains, domain-specific correct rates were around 80% to 90%; however, sensitivity below 0.80 was observed in domains 1 (random sequence generation), 2 (allocation concealment), and 6 (other concerns). Domains 4 (missing outcome data), 5 (selective outcome reporting), and 6 had F1 scores below 0.50. The consistent rates between the 2 assessments were 84.0% for LLM 1 and 87.3% for LLM 2. LLM 1’s κ exceeded 0.80 in 7 and LLM 2’s in 8 domains. The mean (SD) time needed for assessment was 77 (16) seconds for LLM 1 and 53 (12) seconds for LLM 2.ConclusionsIn this survey study of applying LLMs for ROB assessment, LLM 1 and LLM 2 demonstrated substantial accuracy and consistency in evaluating RCTs, suggesting their potential as supportive tools in systematic review processes.

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Antidepressants for insomnia in adults

Everitt

Baldwin

Stuart

et al. 2018

Cochrane Database of Systematic Reviews

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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 6mg in a four-week outpatient trial of elderly adults with chronic primary insomnia

Cited by 77 publications

References 12 publications

Therapeutic rationale for low dose doxepin in insomnia patients

Therapeutic rationale for low dose doxepin in insomnia patients

Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models

Antidepressants for insomnia in adults

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