Skip to main content
construction release_alert
Scholars@Duke will be undergoing maintenance April 11-15. Some features may be unavailable during this time.
cancel
Journal cover image

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.

Publication ,  Journal Article
Roth, T; Krystal, A; Steinberg, FJ; Singh, NN; Moline, M
Published in: Sleep
February 1, 2013

STUDY OBJECTIVES: To 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. DESIGN: Multicenter randomized, double-blind, placebo-controlled, parallel-group. SETTING: Outpatient. 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). INTERVENTIONS: After 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. RESULTS: ZST 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. CONCLUSIONS: 3.5 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 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

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Sleep

DOI

EISSN

1550-9109

Publication Date

February 1, 2013

Volume

36

Issue

2

Start / End Page

189 / 196

Location

United States

Related Subject Headings

  • Zolpidem
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Pyridines
  • Neurology & Neurosurgery
  • Male
  • Hypnotics and Sedatives
  • Humans
  • Female
  • Double-Blind Method
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Roth, Thomas, Andrew Krystal, Frank J. Steinberg, Nikhilesh N. Singh, and Margaret Moline. “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.Sleep 36, no. 2 (February 1, 2013): 189–96. https://doi.org/10.5665/sleep.2370.
Journal cover image

Published In

Sleep

DOI

EISSN

1550-9109

Publication Date

February 1, 2013

Volume

36

Issue

2

Start / End Page

189 / 196

Location

United States

Related Subject Headings

  • Zolpidem
  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Pyridines
  • Neurology & Neurosurgery
  • Male
  • Hypnotics and Sedatives
  • Humans
  • Female
  • Double-Blind Method