Research and Clinical Trials on Zolpidem (Ambien, Stilnoct)

avatar image
By Dr Greg Mulhauser

This list of current clinical research trials on Zolpidem (Ambien, Stilnoct) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

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).

 

Get These Clinical Trials as a Newsfeed

Zolpidem:     Get the Zolpidem clinical trials feed.    Add the Zolpidem clinical trials feed to your My Yahoo! page.    Add the Zolpidem clinical trials feed to your MyMSN page.

Current Research Literature on Zolpidem (Ambien, Stilnoct)

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

Dependence on quetiapine in combination with zolpidem and clonazepam in bipolar depression.

Psychiatry Clin Neurosci. 2009 Jun; 63(3): 427-8
Chen CY, Shiah IS, Lee WK, Kuo SC, Huang CC, Wang TY

Highway driving performance and cognitive functioning the morning after bedtime and middle-of-the-night use of gaboxadol, zopiclone and zolpidem.

J Sleep Res. 2009 Jun 22;
Leufkens TR, Lund JS, Vermeeren A
Gaboxadol is a selective extrasynaptic GABA(A) receptor agonist previously in development for the treatment of insomnia. Due to its short half-life (1.5-2 h) it is expected to be free from residual effects the next morning. The present study assessed the residual effects of evening and middle-of-the-night administration of 15 mg of gaboxadol on cognitive, psychomotor and driving performance. Twenty-eight healthy volunteers entered the study with 25 (12 women; mean age 31.4 years) completing a double-blind, placebo-controlled, active-referenced five-way cross-over study. Each treatment night subjects ingested one capsule at 23:00 hours and one at 04:00 hours. Treatments were placebo at both times, 15 mg gaboxadol or 7.5 mg zopiclone followed by placebo, and placebo followed by 15 mg gaboxadol or 10 mg zolpidem. Effects on cognition and psychomotor performance were assessed between 07:30 and 08:30 hours and on driving between 09:00 and 10:00 hours. Driving, as measured by standard deviation of lateral position in an on-the-road driving test, was almost significantly (P < 0.07) impaired after evening administration of gaboxadol for the all-subjects-completed set (n = 25) but significantly (P < 0.05) in the full analysis set (n = 28). Effects of all other active treatments on driving were significant. Evening administration of gaboxadol had minor effects on divided attention only, whereas middle-of-the-night administration impaired performance significantly in all tests except memory. Zolpidem and zopiclone impaired performance significantly in every test except tracking after zopiclone; 15 mg of gaboxadol can produce minor residual effects on driving after evening administration. Administration later at night is associated with moderately impairing residual effects on driving and psychomotor performance but not on memory.

Sleep complaints: Whenever possible, avoid the use of sleeping pills.

Prescrire Int. 2008 Oct; 17(97): 206-12

(1) Most sleep complaints involve difficulties in getting to sleep or staying asleep, or not feeling refreshed on awakening. Misconceptions and worrying over the lack of sleep and its consequences can contribute to reinforcing these disorders; (2) How can patients who complain of poor-quality sleep be helped, without resorting to treatments that can have adverse effects? To answer this question, we conducted a systematic review of the literature based on the standard Prescrire procedure; (3) One effective approach is to explain the basic physiology of sleep, to discuss misconceptions, and to adopt a strategy of "stimulus control". This method has a similar efficacy to prescribing a benzodiazepine. and the effect is longer lasting; (4) Moderate, regular physical exercise, especially in the morning, seems to help some patients, but the evidence is weak; (5) Some clinical trials of phytotherapy have shown a positive risk-benefit balance of weak aqueous or hydroalcoholic valerian extracts. Efficacy is limited, however; (6) A meta-analysis of placebo-controlled trials showed that benzodiazepines and related drugs increase the duration of sleep and help patients to fall asleep sooner. However, none of these trials provides comparative data spanning periods of more than two weeks. Efficacy is uncertain in the longer term, as patients quickly develop a tolerance to the hypnotic effects of benzodiazepines; (7) The adverse effects of benzodiazepines include frequent memory disorders, daytime drowsiness, falls, fractures and road accidents, and a withdrawal syndrome after treatment cessation. Related drugs such as zolpidem and zopiclone provoke similar adverse effects; (8) Sedative antihistamines have not been as well-evaluated as benzodiazepines in this setting. Small comparative trials of doxylamine and diphenhydramine showed no major difference in efficacy versus benzodiazepines and related drugs. The main adverse effects of sedative antihistamines are daytime drowsiness and altered vigilance, and atropinic effects; (9) Case-control studies showed a statistical link between benzodiazepine use in early pregnancy and birth defects such as cleft lip. In contrast, data on the use of doxylamine during pregnancy are reassuring; (10) Other sedative psychotropics have not been adequately tested in this setting or have been shown to have a negative risk-benefit balance; (11) In practice, patients who complain of poor-quality sleep should be given appropriate information on the mechanisms of normal sleep and related misconceptions, on the best methods for getting to sleep, and on the dangers of sedative psychotropics (dependence, withdrawal syndrome). When prescribing or dispensing a benzodiazepine to a woman of child-bearing age, the risk of birth defects, although not clearly demonstrated, must be mentioned.

Age- and gender-related differences in GABAA receptor-mediated postsynaptic currents in GABAergic neurons of the substantia nigra reticulata in the rat.

Neuroscience. 2009 Jun 13;
O C, H H, K N, S L M, A S G
The responsiveness of the rat anterior substantia nigra pars reticulata (SNR) GABAergic neurons to GABA(A)ergic drugs changes with age and gender, altering its role in seizure control. To determine whether maturational and gender-specific differences in the properties of spontaneous GABA(A)Rs-mediated inhibitory postsynaptic currents (sIPSCs) underlie these events, we studied sIPSCs at baseline and after application of the 1 GABA(A)Rs subunit selective agonist zolpidem, at postnatal days (PN) 5-9, PN12-15, and PN28-32. Results were correlated with the 1 and 3 GABA(A)Rs subunit immunoreactivity (-ir) at PN5, PN15, and PN30, using immunochemistry. The mean frequency, amplitude and charge transfer increased whereas the 10-90% rise time and decay time accelerated with age in both genderes. The faster sIPSC kinetics in older rats were paralleled by increased 1-ir and decreased 3-ir. At PN5-9, males had more robust sIPSCs (frequency, amplitude, charge carried per event and charge transfer) than females. At PN28-32, males exhibited higher amplitudes and faster kinetics than females. The zolpidem-induced increase of decay times, amplitude and charge transfer and 1-ir expression were the lowest in PN5-9 males but increased with age, in both genders. Our findings demonstrate that alterations in GABA(A)Rs subunit expression partially underlie age- and gender-specific sIPSC changes in SNR neurons. However, the observation of gender differences in sIPSC kinetics that cannot be attributed to changes in perisomatic 1 expression suggests the existence of additional gender-specific factors that control the sIPSC kinetics in rat SNR.

Zolpidem in fatigue management for surge operations of remotely piloted aircraft.

Aviat Space Environ Med. 2009 Jun; 80(6): 553-5
Van Camp RO
INTRODUCTION: Zolpidem is a hypnotic medication approved to manage sleep for crewmembers involved in combat operations in the USAF and other services. Previous studies demonstrated the effectiveness of zolpidem under laboratory conditions, but confirmation from the field is needed. METHODS: We evaluated zolpidem in managing sleep-work cycles for crews of remotely piloted aircraft (RPA) during surge combat operations. There were 3 10-mg tablets of zolpidem dispensed to each of 43 crewmembers tasked to support RPA surge combat operations requiring rapid unscheduled shift changes. All personnel were required to take the drug on a non-flying day to evaluate its individual effect; use of the drug during operations was voluntary. RESULTS: The surge operations were carried out successfully with no flight or ground mishaps. There were 27 crewmembers (63%) who used the medication. Of those, 19 reported that the intervention resulted in good sleep without side effects or morning drowsiness. The other eight subjects reported side effects consisting of drug hangover (N = 4) or poor sleep with frequent awakening (N = 4). There were no reports of abnormal sleep behaviors. Five crewmembers considered the medication essential to duty performance. CONCLUSION: Zolpidem promoted the safe induction of sleep and was used successful by a majority of the RPA crewmembers. Side effects occurred in some crewmembers even though they had previously tested the drug without side effects. A small subset of the test group heavily relied on medication to successfully manage their sleep-rest cycle.

 

This page was last reviewed by Dr Greg Mulhauser, Monday, 1 June 2009.

The URL of this page is:
http://counsellingresource.com/medications/trials-and-research/zolpidem-research.html