Trial reportSleep2013
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.
Trial report in Sleep, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00466193 (A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Pooled it
- Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017Guideline
- Efficacy and safety of Shugan Jieyu capsules in combination with zolpidem for insomnia disorder with depressive symptoms: a double-blind randomized controlled trial.BMC complementary medicine and therapies · 2025Trial
- Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2020Trial
- Pharmacokinetics of zolpidem from sublingual zolpidem tartrate tablets in healthy elderly versus non-elderly subjects.Drugs & aging · 2014Trial
- Trial
- 2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults - Brazilian Sleep Association.Sleep science (Sao Paulo, Brazil) · 2023Review
- Zolpidem: Efficacy and Side Effects for Insomnia.Health psychology research · 2021Review
- The assessment and management of insomnia: an update.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2019Article
- How representative are insomnia clinical trials?Sleep medicine · 2018Article
- Insomnia in Elderly Patients: Recommendations for Pharmacological Management.Drugs & aging · 2018Review
- Challenges and Future Prospects for the Delivery of Biologics: Oral Mucosal, Pulmonary, and Transdermal Routes.The AAPS journal · 2017Article
- People with insomnia: experiences with sedative hypnotics and risk perception.Health expectations : an international journal of public participation in health care and health policy · 2016Article
- Optimizing the Pharmacologic Treatment of Insomnia: Current Status and Future Horizons.Sleep medicine clinics · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo evaluate efficacy and safety of 3.5-mg zolpidem tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia characterized by difficulty returning to sleep after MOTN awakenings.
designMulticenter randomized, double-blind, placebo-controlled, parallel-group.
settingOutpatient. PATIENTS: There were 295 adults (median age 43 y; 68.1% female) with primary insomnia and difficulty returning to sleep after MOTN awakenings (three or more MOTN awakenings/wk during screening).
interventionsAfter a 2-wk, single-blind placebo eligibility period, participants were randomized 1:1 to as-needed MOTN dosing with 3.5 mg ZST or placebo for 28 nights. An interactive voice response system determined if the study drug could be taken and recorded sleep/wake efficacy measures.
resultsZST significantly (P < 0.0001) decreased latency to sleep onset over 4 wk (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min). Ratings of morning sleepiness/alertness significantly (P = 0.0041) favored the ZST group on nights medication was taken but not on other nights. Participants in the ZST group took the study drug on 62% of nights during the 4 wk; members of the placebo group took study medication on 64% of nights. Adverse events were generally mild and at the same rate (19.3% of participants) in both groups. There were no treatment-related serious adverse events (SAEs), and one adverse event-related study discontinuation from the placebo group. Dosing/week did not increase across the study.
conclusions3.5 mg ZST used as needed significantly reduced latency to return to sleep in comparison with placebo in these patients with insomnia. Sleep quality was improved, and morning sleepiness/alertness scores also improved. ZST was well tolerated. These data demonstrate the utility of a sleep-promoting agent when used as needed in the MOTN. CLINICAL TRIAL INFORMATION: CLINICAL TRIALS REGISTRATION: 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
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.