Research and Clinical Trials on Zolpidem (Ambien, Stilnoct)

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).

• Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
  Status: Active, not recruiting, Condition Summary: Sleep Disorders
• Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
  Status: Not yet recruiting, Condition Summary: Sleep Disorder
• Almorexant in Adult Subjects With Chronic Primary Insomnia
  Status: Recruiting, Condition Summary: Chronic Primary Insomnia
• Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
  Status: Completed, Condition Summary: Insomnia
• Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer
  Status: Recruiting, Condition Summary: Breast Cancer; Hot Flashes; Sleep Disorders
• Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs
  Status: Terminated, Condition Summary: Primary Insomnia
• Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Under Fasting Conditions
  Status: Completed, Condition Summary: Healthy
• A Double-Blind, Group-Comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
  Status: Completed, Condition Summary: Sleep Initiation and Maintenance Disorders
• Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
  Status: Recruiting, Condition Summary: Sleep Initiation and Maintenance Disorders; Insomnia
• Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
  Status: Recruiting, Condition Summary: Insomnia
• Stilnox Treatment in Elderly Patients With Insomnia
  Status: Completed, Condition Summary: Insomnia
• A Study to Assess Facilitation of the Discontinuation of Zolpidem by Ramelteon Administration in Subjects With Chronic Insomnia
  Status: Active, not recruiting, Condition Summary: Chronic Insomnia
• A Safety Study of Ramelteon in Elderly People
  Status: Completed, Condition Summary: Insomnia
• Magnetoencephalographic (MEG) Localization of Ramelteons Effects on Brain Function and Cortical Arousal in Insomnia
  Status: Recruiting, Condition Summary: Insomnia
• Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Tablets
  Status: Completed, Condition Summary: Healthy; Therapeutic Equivalency

 

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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):

Delayed-onset hepatic encephalopathy induced by zolpidem: a case report.

Clinics. 2008 Aug; 63(4): 565-6
Silva VC, Bittencourt PL, Pinho S, Cavalcanti AR, Zollinger CC

Hypnotic use for insomnia management in chronic obstructive pulmonary disease.

Sleep Med. 2008 Aug 8;
Roth T
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of mortality and morbidity worldwide. Because of the chronic nature of the disease, optimal care for patients includes successful treatment of comorbidities that accompany COPD, including insomnia. Insomnia symptoms and associated disruption of sleep are prevalent in COPD patients but treatment with traditional benzodiazepines may compromise respiratory function. This review summarizes the efficacy and safety consideration of current drugs available for the treatment of insomnia in COPD patients including benzodiazepines, non-benzodiazepine receptor agonists such as eszopiclone, zolpidem, and zaleplon, sedating antidepressants such as trazodone, and the melatonin receptor agonist ramelteon.

Zolpidem and traffic safety - the importance of treatment compliance.

Curr Drug Saf. 2007 Sep; 2(3): 220-6
Verster JC, Volkerts ER, Olivier B, Johnson W, Liddicoat L
Zolpidem is among the most frequently prescribed hypnotic drugs for those who suffer from insomnia. Recent media reports drew attention to driving impairment after zolpidem misuse. This review summarizes the available data on the effects of recommended use and misuse of zolpidem on driving ability and traffic safety. Both experimental studies and roadside evidence were taken into account. From these studies it must be concluded that patients should fully comply with the prescription instructions of zolpidem, i.e. to take the medication just prior to a full 8 hours of uninterrupted sleep. If this strategy is adopted, zolpidem is a safe alternative to benzodiazpine hypnotics and zopiclone who do show significant driving impairment the morning following bedtime administration. However, to ensure traffic safety higher dosages than recommended (10 mg) or allowing less than 8 hours between zolpidem intake and actual operation of a motor vehicle should be avoided.

Hypnotics and driving safety: meta-analyses of randomized controlled trials applying the on-the-road driving test.

Curr Drug Saf. 2006 Jan; 1(1): 63-71
Verster JC, Veldhuijzen DS, Patat A, Olivier B, Volkerts ER
BACKGROUND: Many people who use hypnotics are outpatients and are likely to drive a car the day after drug intake. The purpose of these meta-analyses was to determine whether or not this is safe. METHODS: Placebo-controlled, randomized, double-blind trials were selected if using the on-the-road driving test to determine driving ability the day following one or two nights of treatment administration. Primary outcome measure of the driving test was the Standard Deviation of Lateral Position (SDLP); i.e., the weaving of the car. Fixed effects model meta-analyses were performed. Effect size (ES) was computed using mean standardized (weighted) difference scores between treatment and corresponding placebo SDLP values. RESULTS: Ten studies, published from 1984 to 2002 (207 subjects), were included in the meta-analyses. The morning following bedtime administration, i.e. 10-11 hours after dosing, significant driving impairment was found for the recommended dose of various benzodiazepine hypnotics (ES=0.42; 95% Confidence Interval (CI)=0.14 to 0.71). Twice the recommended dose impaired driving both in the morning (ES=0.68; CI=0.39 to 0.97) and afternoon, i.e. 16-17 hours after dosing (ES=0.57; CI=0.26 to 0.88). Zopiclone 7.5 mg also impaired driving in the morning (ES=0.89; CI=0.54 to 1.23). Zaleplon (10 and 20 mg) and zolpidem (10 mg) did not affect driving performance the morning after dosing. Following middle-of-the-night administration, significantly impaired driving performance was found for zopiclone 7.5 mg (ES=1.51, CI=0.85 to 2.17), zolpidem 10 mg (ES=0.66, CI=0.13 to 1.19) and zolpidem 20 mg (ES=1.16, CI=0.60 to 1.72). Zaleplon (10 and 20 mg) did not affect driving performance. CONCLUSIONS: The analyses show that driving a car the morning following nocturnal treatment with benzodiazepines and zopiclone is unsafe, whereas the recommended dose of zolpidem (10 mg) and zaleplon (10 mg) do not affect driving ability.

Post-hypoxic changes in rat cortical neuron GABA(A) receptor function require L-type voltage-gated calcium channel activation.

Neuropharmacology. 2008 Jul 12;
Wang L, Greenfield LJ
Hypoxia modifies GABA(A) receptor (GABA(A)R) function and can cause seizures, encephalopathy or myoclonus. To characterize the effects of hypoxia on neuronal GABA(A)Rs, we subjected rat cortical neurons to 1% O(2) for 2, 4 or 8h, followed by recovery times of 0-96h, and used whole-cell and perforated patch-clamp recording to assess GABA(A)R currents and pharmacology. Hypoxic exposure for 4h caused downregulation of maximal GABA current immediately following hypoxia and after 48h recovery without changing the EC(50) for GABA. Two- and eight-hour hypoxic exposures had inconsistent effects on GABA(A)R currents. Maximal diazepam potentiation was increased immediately following 4h hypoxia, while potentiation by zolpidem was increased after 48h recovery. Pentobarbital enhancement and zinc inhibition of GABA currents were unchanged. Hypoxia also caused a depolarizing shift in the reversal potential of GABA-induced Cl(-) currents after 24h recovery. The L-type voltage-gated calcium channel (L-VGCC) blocker, nitrendipine, during hypoxia or control treatment prevented the reduction in GABA(A)R currents, and increased control currents over baseline. Nitrendipine also prevented the increase in zolpidem potentiation 48h after hypoxia, and blocked the depolarizing shift in Cl(-) reversal potential 24h after hypoxia. The effects of hypoxia on maximal GABA(A)R currents, zolpidem pharmacology and Cl(-) reversal potential thus require depolarization-induced calcium entry via L-VGCCs, and constitutive L-VGCC activity appears to reduce maximal GABA(A)R currents in control neurons via a calcium-dependent process. Calcium-dependent modulation of GABA(A)R currents via L-VGCCs may be a fundamental regulatory mechanism for GABA receptor function.