Novel Sublingual Low-Dose Zolpidem Tablet Reduces Latency to Sleep Onset following Spontaneous Middle-of-the-Night Awakening in Insomnia in a Randomized, Double-Blind, Placebo-Controlled, Outpatient Study

Roth, Thomas; Krystal, Andrew D.; Steinberg, Frank; Singh, Neeti Rajan; Moline, Margaret

doi:10.5665/sleep.2370

Cited by 45 publications

(34 citation statements)

References 7 publications

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“…Erman Fourteen additional studies met inclusion criteria but could not be included in meta-analysis due to inadequate data sets. 71,[83][84][85][86][87][88][89][90][91][92][93][94][95] Pertinent results from these studies are noted independently of meta-analysis results.…”

Section: Discussionmentioning

confidence: 99%

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0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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Introduction:The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations:The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance in...

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Section: Discussionmentioning

confidence: 99%

“…57 [88][89][90]92,94,95 These studies varied significantly with regard to drug preparation, dosage, mode of administration and methodology, rendering comparisons between them or to the meta-analytic data difficult. Four of the six evaluated sublingual zolpidem, primarily for treatment of middle-of-the-night (MOTN) awakenings.…”

Section: Sleep Latencymentioning

confidence: 99%

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

View full text Add to dashboard Cite

show abstract

“…Six studied individual in-person CBT-I, [54][55][56]60,62,65 five studied group CBT-I, 53,57,59,61,72 one studied phonedelivered CBT-I, 51 and ten studied self-help CBT-I using either books or handouts or electronic resources. 52,58,63,64,[66][67][68][69][70][71] Comparison groups also varied across trials. Some trials attempted to have a placebo control group that received similar therapy hours (i.e., quasi-desensitization or stress management).…”

Section: Overview Of Studiesmentioning

confidence: 99%

“…Double blind study and with a low attrition rate. Roth 2013; 69 Roth 2014 70 Low Adjusted for multiple comparisons using hierarchy; 20/294 (7%) attrition; reporting bias, i.e., data only for TST; outcomes for NOW, SL must be estimated from figure; no data for WASO Herring 2014; 71 Herring 2012 72 Low. Computer-generated randomization schedule based on input from a blinded Merck statistician.…”

Section: Appendix a Search Strategies Key Question Trials Searches -mentioning

confidence: 99%

Cognitive Behavioral Therapy in the Treatment of Insomnia

Haynes¹,

Talbert²,

Fox³

et al. 2018

Southern Medical Journal

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“…45 However, effect sizes for improvements in daytime functioning, including alertness, ability to concentrate and to function, and physical well-being, were modest for all groups, although highest in groups with primary insomnia and lowest in those with comorbid psychiatric conditions. Roth et al 46 examined sublingual low-dose zolpidem (3.5 mg) for patients with primary insomnia and difficulty returning to sleep after nighttime awakenings (N = 295). Results showed that, compared with placebo, this formulation significantly decreased sleep latency (P < .0001) and favored zolpidem in ratings of morning sleepiness/alertness (P = .004).…”

Section: Fda-approved Prescription Medications For Insomniamentioning

confidence: 99%

Understanding the Sleep-Wake Cycle: Sleep, Insomnia, and the Orexin System

Krystal¹,

Benca²,

Kilduff³

2013

J. Clin. Psychiatry

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Novel Sublingual Low-Dose Zolpidem Tablet Reduces Latency to Sleep Onset following Spontaneous Middle-of-the-Night Awakening in Insomnia in a Randomized, Double-Blind, Placebo-Controlled, Outpatient Study

Abstract: NCT00466193: "A Study of Zolpidem Tartrate Tablet in Adult Patients with Insomnia" http://www.clinicaltrials.gov/ct2/show/NCT00466193?spons=%22Transcept+Pharmaceuticals%22&spons_ex=Y&rank=2

Cited by 45 publications

References 7 publications

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Cognitive Behavioral Therapy in the Treatment of Insomnia

Understanding the Sleep-Wake Cycle: Sleep, Insomnia, and the Orexin System

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