Patients With Treatment-Resistant Insomnia Taking Nightly Prescription Medications for Sleep

Krakow, Barry; Ulibarri, Victor A.; Romero, Edward

doi:10.4088/pcc.09m00873bro

Cited by 13 publications

(14 citation statements)

References 31 publications

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“…11,14,29 In comparison to some studies conducted in non-veteran populations that employed a lower AHI threshold (AHI ≥ 5), our study's prevalence rate is slightly lower. 12,30,31 As described in our methods section, we chose a conservative AHI threshold of ≥ 15; our prevalence rate would have been much higher if we had selected an AHI ≥ 5. Compared to two other studies in non-veteran populations that employed the same AHI threshold used in our study, 11,14 we found a higher prevalence rate among older veterans.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Symptoms of Occult Sleep Disordered Breathing among Older Veterans with Insomnia

Fung

Martin

Dzierzewski³

et al. 2013

Journal of Clinical Sleep Medicine

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Study Objectives: To determine the prevalence of occult sleep disordered breathing (SDB) and describe the relationship between classic SDB symptoms (e.g., loud snoring) and occult SDB in older veterans with insomnia. Methods: We analyzed baseline survey and in-home sleep study data for 435 veterans (mean age = 72.0 years [SD 8.0]) who had no known history of SDB, met International Classifi cation of Sleep Disorders 2 nd Edition criteria for insomnia, and were enrolled in a behavioral intervention trial for insomnia. Variables of interest included apnea-hypopnea index (AHI) ≥ 15, age, race/ethnicity, marital status, body mass index (BMI), insomnia subtype (i.e., onset, maintenance, or terminal), self-reported excessive daytime sleepiness, snoring, and witnessed breathing pause items from the Berlin Questionnaire. We computed the frequency of AHI ≥ 15 and assessed whether each classic SDB symptom was associated with an AHI ≥ 15 in 4 separate multivariate logistic regression models.Results: Prevalence of AHI ≥ 15 was 46.7%. Excessive daytime sleepiness (adjusted odds ratio 1.63, 95% CI 1.02, 2.60, p = 0.04), but not snoring loudness, snoring frequency, or witnessed breathing pauses was associated with occult SDB (AHI ≥ 15). Insomnia subtypes were not signifi cantly associated with occult SDB (p > 0.38). Conclusions: In our sample of older veterans with insomnia, nearly half had occult SDB, which was characterized by reported excessive daytime sleepiness, but not loud or frequent snoring or witnessed breathing pauses. Insomnia subtype was unrelated to the presence of occult SDB.

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Section: Discussionmentioning

confidence: 99%

Prevalence and Symptoms of Occult Sleep Disordered Breathing among Older Veterans with Insomnia

Fung

Martin

Dzierzewski³

et al. 2013

Journal of Clinical Sleep Medicine

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“…[5][6][7][8] Given this evidence of long-term hypnotic use in insomnia, it is also of interest to assess long-term gender differences in the efficacy and safety of zolpidem. Controlled studies using polysomnography (PSG) to evaluate hypnotic efficacy for 6 months and beyond have shown continued efficacy.…”

Section: Introductionmentioning

confidence: 99%

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem

Roehrs

Roth

2016

Journal of Clinical Sleep Medicine

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Study Objectives: Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either shortor long-term differences in efficacy and safety. Methods: To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Results: Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. Conclusions:In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. Clincial Trials Registration: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/ show/NCT01006525. Keywords: gender differences, primary insomnia, zolpidem Citation: Roehrs TA, Roth T. Gender differences in the efficacy and safety of chronic nightly zolpidem. J Clin Sleep Med 2016;12(3):319-325. I NTRO DUCTI O NGender-related pharmacokinetic differences in zolpidem plasma concentration have been reported, with plasma concentrations in women being higher and clearance slower than in men. Men metabolized the 10 mg standard formulation of zolpidem at approximately double the rate of women.1,2 The peak concentration of the sublingual formulation of zolpidem was 45% higher in women than men.3 Some studies have shown that these pharmacokinetic differences are associated with safety differences. At 5 h post daytime zolpidem administration and testing, poorer automobile driving was found 3 and in the morning 4 h after middle of the night zolpidem administration, poorer automobile driving was shown in women than men. 4 It should be noted that these pharmacokinetic studies were done in healthy volunteers and not patients with insomnia for whom this medication is indicated.Many insomnia patients use prescription hypnotics chronically, with over half taking hypnotics longer than 4 weeks, likely due to their chronic and frequent symptomatology. [5][6][7][8] Given this evidence of long-term hypnotic use in insomnia, it is also of interest to assess long-term gender differences in the efficacy and safety of zolpidem. Contro...

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“…In the only prior study of patients whose insomnia was resistant to treatment with prescription sleep-aids including BzRAs, levels of comorbid psychopathology were high. 6 However, this study lacked a comparator group of treatment responders, rendering it difficult to implicate comorbid psychopathology in treatmentresistance. Another report presented post hoc analyses of BzRA treatment from 5 different efficacy trials, including patients with "primary" insomnia and those with insomnia comorbid with depression, GAD, menopause, and arthritis.…”

Section: 38mentioning

confidence: 99%

“…[3][4][5] As such, efficacy in a controlled trial may not translate to effectiveness in clinical practice. A recent report 6 identified a series of sleep clinic patients with persistent insomnia symptoms despite chronic nightly use of prescription sleep-aids, of which BzRAs were the most commonly used and accounted for two-thirds of all sleep-aids. However, as only nonremitters were included in this study, rates of remission (and nonremission) from insomnia disorder among BzRA users in clinical settings is currently unknown.…”

Section: Introductionmentioning

confidence: 99%

“…Psychiatric/medical disorders are comorbid with insomnia in 70% to 86% of cases, [14][15][16] and have been proposed as an important factor in the effectiveness of prescription sleep-aids. 6 The exclusion of patients with medical and psychiatric disorders in efficacy trials has been criticized for this reason since as early as 1989. [3][4][5] In its prescribing information (label) for 2 common BzRAs, the FDA notes that nonremission from insomnia while taking these medications may reflect a comorbid condition warranting assessment.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of Benzodiazepine Receptor Agonists in the Treatment of Insomnia: An Examination of Response and Remission Rates

Pillai

Roth

Roehrs

et al. 2016

Sleep

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Study objectives:To examine the real-world effectiveness of benzodiazepine receptor agonists (BzRAs) by quantifying response and remission rates in a clinical sample receiving chronic BzRA treatment for insomnia. Methods: Participants were outpatients (N = 193; 72% female; 55.2 ± 11.1 year) who had an insomnia diagnosis per medical records, and who were taking a therapeutic dose of BzRA for their insomnia. Endpoints were nocturnal sleep disturbance and Insomnia Severity Index (ISI) scores. A reduction meeting the criterion for the minimally important difference in ISI scores (change ≥ 6) constituted "response"; "remission" was inferred when symptoms fell below the clinical cutoff (ISI < 11). Results: Most participants (71%) used BzRAs at least 5 nights per week. Mean ISI scores were significantly lower (t = 22.31; p < .01) while on BzRAs than when untreated, but remained in the clinical range (mean = 11.0; standard deviation = 5.7). Although 76.7% responded to treatment, only 47.7% remitted. The majority (68.9%) of participants had a sleep-onset latency > 30 minutes and/or wake-time after sleep onset > 60 minutes while on BzRAs. After controlling for gender and insomnia severity when untreated, odds of insomnia persistence despite BzRA use were 2 times higher in patients with comorbid medical [odds ratio (OR) = 2.39; 95% confidence interval (CI) = 1.20% to 4.77%; p < .05] and psychiatric disorders (OR = 2.24; 95% CI = 1.21% to 4.13%; p < .05). Conclusions: This is the first study to distinguish between response and remission in insomnia patients taking BzRAs. Findings suggest that while many insomnia patients respond to chronic BzRA treatment, most do not remit. Remission rates are particularly low for comorbid insomnia, the most prevalent phenotype of the disorder.

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Patients With Treatment-Resistant Insomnia Taking Nightly Prescription Medications for Sleep

Cited by 13 publications

References 31 publications

Prevalence and Symptoms of Occult Sleep Disordered Breathing among Older Veterans with Insomnia

Prevalence and Symptoms of Occult Sleep Disordered Breathing among Older Veterans with Insomnia

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem

Effectiveness of Benzodiazepine Receptor Agonists in the Treatment of Insomnia: An Examination of Response and Remission Rates

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