Zolpidem (Ambien, Stilnoct) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Zolpidem (Ambien, Stilnoct).

• Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
  Status: Not yet recruiting, Condition Summary: Insomnia
• Sequenced Therapies for Comorbid and Primary Insomnias
  Status: Recruiting, Condition Summary: Insomnia Comorbid to Psychiatric Disorder; Primary Insomnia
• Orthostatic Hypotension Treatment on Rehab Unit
  Status: Enrolling by invitation, Condition Summary: Orthostatic Hypotension; Falls
• Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
  Status: Completed, Condition Summary: Insomnia; Primary Insomnia; Psychophysiologic Insomnia

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Current Research Literature on Zolpidem (Ambien, Stilnoct)

Here are abstracts for some of the latest research articles to have appeared on Zolpidem (Ambien, Stilnoct):

Segmental Hair Analysis after a Single Dose of Zolpidem: Comparison with a Previous Study.

J Anal Toxicol. 2013 May 8;
Cui X, Xiang P, Zhang J, Shi Y, Shen B, Shen M
Hair is a useful aid and sometimes even the only matrix in the analytical strategy in drug-facilitated crime (DFC) investigations. In this novel study, segmental hair analysis was performed after a single 10 mg dose of zolpidem was given to 20 Chinese volunteers. Hair was collected 1 month after administration and was analyzed using ultra-high-pressure liquid chromatography/electrospray ionization tandem mass spectrometry. Zolpidem concentrations were found to be in the range of 135.0-554.6 pg/mg in the proximal 0-2 cm segments. These results were markedly different from those reported by Villain et al., who used volunteers administered equal doses of zolpidem. The analytical method used, as well as the volunteers' hair color, inter-individual variations such as metabolic capacity, hair growth rate, drug incorporation rates, physical state of the hair, age, gender, body weight, etc. and diffusion from sweat or other secretions are all factors that should be considered when interpreting the DFC results.

Partial Agonism of Taurine at Gamma-Containing Native and Recombinant GABAA Receptors.

PLoS One. 2013; 8(4): e61733
Kletke O, Gisselmann G, May A, Hatt H, A Sergeeva O
Taurine is a semi-essential sulfonic acid found at high concentrations in plasma and mammalian tissues which regulates osmolarity, ion channel activity and glucose homeostasis. The structural requirements of GABAA-receptors (GABAAR) gated by taurine are not yet known. We determined taurine potency and efficacy relative to GABA at different types of recombinant GABAAR occurring in central histaminergic neurons of the mouse hypothalamic tuberomamillary nucleus (TMN) which controls arousal. At binary α1/2β1/3 receptors taurine was as efficient as GABA, whereas incorporation of the γ1/2 subunit reduced taurine efficacy to 60-90% of GABA. The mutation γ2F77I, which abolishes zolpidem potentiation, significantly reduced taurine efficacy at recombinant and native receptors compared to the wild type controls. As taurine was a full- or super- agonist at recombinant αxβ1δ-GABAAR, we generated a chimeric γ2 subunit carrying the δ subunit motif around F77 (MTVFLH). At α1/2β1γ2(MTVFLH) receptors taurine became a super-agonist, similar to δ-containing ternary receptors, but remained a partial agonist at β3-containing receptors. In conclusion, using site-directed mutagenesis we found structural determinants of taurine's partial agonism at γ-containing GABAA receptors. Our study sheds new light on the β1 subunit conferring the widest range of taurine-efficacies modifying GABAAR function under (patho)physiological conditions.

Zolpidem improves tardive dyskinesia and akathisia.

Mov Disord. 2013 May 1;
Waln O, Jankovic J

Determination of zolpidem in human hair by micropulverized extraction based on the evaluation of relative extraction efficiency of seven psychoactive drugs from an incurred human hair specimen.

J Chromatogr A. 2013 Jun 7; 1293: 28-35
Miyaguchi H
A micropulverization method for rapid extraction of psychoactive drugs from hair was developed. A hair sample (10mg) was micropulverized for 10min at 42Hz with 0.2mL of 45% (w/v) aqueous ammonium phosphate (pH 8.4). Liquid-liquid extraction was carried out in the same tube using acetonitrile, and the organic layer was removed and filtered. Conventional methods, including solid-liquid extraction with an ammonium phosphate solution or methanol, were also employed, and the relative extraction efficiencies of amitriptyline, nortriptyline, norfludiazepam, flunitrazepam, 7-aminoflunitrazepam, mianserin and zolpidem with these methods from an incurred human hair specimen were compared using liquid chromatography/tandem mass spectrometry. The highest extraction efficiencies for all the analytes were achieved using the method developed here, even though the extraction time (10min) was short. Overnight methanol extraction has frequently been used for hair analysis; however, the extraction efficiency was not sufficient for amines. The method was successfully applied to the quantification of zolpidem in human hair. The range of quantification was 1-25,000pg/mg, and interday accuracy and precision (n=5) at three concentrations were 1.8-8.8% and 3.3-8.1%, respectively. The developed method was applied to three actual (incurred) samples, for which the concentrations of zolpidem were determined to be 78.9-18,300 (pg/mg).

Tolerability, pharmacokinetics, and pharmacodynamics of single-dose almorexant, an orexin receptor antagonist, in healthy elderly subjects.

J Clin Psychopharmacol. 2013 Jun; 33(3): 363-70
Hoever P, Hay J, Rad M, Cavallaro M, van Gerven JM, Dingemanse J
Sleep disorders are common in the elderly population. Orexin receptor antagonism has been proposed as a new sleep-enabling approach to treat insomnia. The tolerability, pharmacokinetics, and pharmacodynamics of ascending single doses of almorexant, a dual orexin receptor antagonist, were investigated in healthy elderly male and female subjects. In this double-blind, placebo- and active-controlled study, each dose (100, 200, and 400 mg) was investigated in a separate group of 12 subjects (almorexant, placebo, and zolpidem 10 mg in an 8:2:2 ratio). Morning doses of almorexant were well tolerated. As expected for sleep-enabling compounds, somnolence and fatigue were frequently reported. Other adverse events included headache and nausea. Muscular weakness was reported at a higher incidence only with the highest almorexant dose. The pharmacokinetic profile of almorexant was characterized by a median time to the maximum concentration of 1.5 hours, quick disposition with a distribution half-life of 1.6 hours, and rapidly decreasing concentrations to approximately 20% of the maximum concentration over 8 hours, with a terminal half-life of 32 hours. Objective pharmacodynamic measures showed decreases in saccadic peak velocity and adaptive tracking performance and increases in body sway with the 400-mg dose of almorexant. Subjective assessments revealed a dose-dependent decrease in alertness. Almorexant had no effects on mood, calmness, subjective internal and external perception, and feeling high. These findings provide a solid basis to study the effects of almorexant in elderly patients with insomnia.