Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle‐of‐the‐night awakening in insomnia

  title={Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle‐of‐the‐night awakening in insomnia},
  author={Thomas Roth and Frank Steinberg and Nikhilesh N. Singh and Margaret Moline},
  journal={Human Psychopharmacology: Clinical and Experimental},
Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet (ZST) formulation. 
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial
The safety and efficacy of both zolpidem formulations are comparable, and the sublingual 5 mg dose induced sleep more rapidly, compared to the oral dose, at bedtime and “as needed” following middle-of-the-night awakenings. Expand
Zolpidem and Gender: Are Women Really At Risk?
Dose reduction in women of zolpidem is not supported by available scientific evidence, and may in fact lead to underdosing and the consequent hazard of inadequately treated insomnia. Expand
Advances in the management of chronic insomnia
Advances in the past six years in both non-pharmacologic and pharmacologic treatments for patients with chronic insomnia are discussed and the controversies surrounding some of the current drug treatments are reviewed. Expand
Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes
The percentage of overall patients in the University of Colorado Health system, and specifically young women, with initial prescriptions for low-dose zolpidem significantly increased as compared to before the labeling change, and the change was only significant in young women. Expand
Sex bias persists in surgical research: A 5-year follow-up study.
The majority of articles failed to report, analyze, or discuss results based on sex, which will negatively affect clinical translatability and outcomes of evidence-based medicine. Expand


Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose sublingual transmucosal zolpidem hemitartrate
This double‐blind placebo‐controlled cross‐over study evaluated the pharmacokinetics and daytime‐sedative profile of 1.0, 1.75, and 3.5 mg dose of the ST zolpidem formulation for the treatment of middle‐of‐the‐night insomnia. Expand
Low-dose sublingual zolpidem tartrate is associated with dose-related improvement in sleep onset and duration in insomnia characterized by middle-of-the-night (MOTN) awakenings.
Low-dose sublingual zolpidem tartrate may be suitable for treatment of patients who have difficulty resuming sleep after MOTN awakenings, and was generally safe and well tolerated in this Randomized, double-blind, placebo-controlled, 3-way crossover study. Expand
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.
3.5 mg ZST used as needed significantly reduced latency to return to sleep in comparison with placebo in these patients with insomnia, and sleep quality was improved, and morning sleepiness/alertness scores also improved. Expand
Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.
Gaboxadol 15 mg showed variable efficacy on measures of sleep duration and onset at 3 months in adult patients with Primary Insomnia in these studies and appeared to be more effective in women than men. Expand
Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences.
The complete dependence of triazolam clearance on CYP3A activity, as opposed to the mixed CYP participation in zolpidem clearance, may explain the differing sex effects on clearance of the two compounds. Expand
Insomnia symptoms in older adults: associated factors and gender differences.
  • I. Jaussent, Y. Dauvilliers, +5 authors A. Besset
  • Psychology, Medicine
  • The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry
  • 2011
The data suggest that women may have specific predisposition factors of multiple IS, which may involve both behavioral and hormonal factors, and Identification and treatment of these risk factors may form the basis of an intervention program for reduction of IS in the elderly. Expand
Pharmacokinetic properties of zolpidem in elderly and young adults: possible modulation by testosterone in men.
The clinical and in vitro data suggest that reduced free serum testosterone may have a modulatory role in age-dependent changes in zolpidem pharmacokinetics in men and recommendations of lower clinical doses of zolPidem in the elderly are consistent with recommendations. Expand
Fatigue, insomnia and nervousness: gender disparities and roles of individual characteristics and lifestyle factors among economically active people
Women suffered more from fatigue/insomnia and nervousness and used more drug for those disorders than men and Socio-demographic and lifestyle factors played significant roles among men and women but they did not explain the gender disparities. Expand
Sex and gender aspects in anesthetics and pain medication.
There is an obvious need for more research, which should include psychological and social factors in experimental preclinical and clinical paradigms in view of their importance on pain mechanism, in order to individualize analgesia to optimize pain relief. Expand
Impact of Sex and Gender on Irritable Bowel Syndrome
Sex and gender modulation of gastrointestinal motility and transit, visceral pain sensitivity, autonomic nervous system function, serotonin biochemistry, and differences in health care-seeking behavior for IBS are examined. Expand