Zolpidem placebo-controlled studies

Voderholzer U, Riemann D, Hornyak M, et al A double-blind, randomized and placebo-controlled study on the polysomnographic withdrawal effects of zopiclone, zolpidem and triazolam in healthy subjects. Eur Arch Psychiatry Clin Neurosci 251 117-123, 2001... 

Scharf MB, Roth T, Vogel GW, Walsh JK. A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia. J Clin Psychiatry 1994 55(5) 192-199. 

Walsh JK. Zolpidem as needed for the treatment of primary insomnia a doubleblind placebo-controlled study. Sleep Med Rev 2002 6(suppl 1) S7-S11. 

The pharmacokinetics and pharmacodynamics of zaleplon (10 or 20 mg) and zolpidem (10 or 20 mg) have been investigated in a randomized, double-blind, crossover, placebo-controlled study in 10 healthy volunteers with no history of sleep disorder (15). The half-life of zaleplon was significantly shorter than that of zolpidem. Zaleplon produced less sedation than zolpidem at the two doses studied, and the sedation scores in the zaleplon groups returned to baseline sooner than in the zolpidem groups. Zaleplon had no effect on recent or remote recall, whereas zolpidem had a significant effect on both measures. 

In a double-blind, placebo-controlled study in eight healthy men, zolpidem 10 mg produced statistically significant postural sway in the tandem stance test, and triazolam 0.25 mg was statistically significant only as defined by the polygonal area of foot pressure center (23). Zolpidem, which has a minimal muscle-relaxant effect, produced more imbalance than triazolam, which is known for its muscle relaxant effect. The authors suggested that in the use of hypnotics, sway derives from suppression of the central nervous system relevant to awakening rather than from muscle relaxation. 

In a double blind, placebo-controlled study in 36 young healthy volunteers, zolpidem 5 or 10 mg increased N2 and P3 latencies and reduced N2 and P3 amplitudes (29). However, contrary to expectations, there was no change in N1 while P2 amplitude was increased by the higher... 

In a double-blind, crossover, randomized, placebo-controlled study in 22 healthy volunteers, single doses of zolpidem 10 mg and triazolam 0.25 mg had no effect on the enhanced non-word recall observed after sleep or on improvement in the performance of a digit symbol substitution test in subjects who slept (30). The authors concluded that the hypnotics did not interfere with nocturnal sleep-induced improvement in memory. 

Fluconazole. In a placebo-controlled study in healthy subjects itraconazole 100 mg twice daily for 2 days had no significant effect on the pharmacokinetics of a single 5-mg dose of zolpidem given with the third dose of fluconazole. ... 

There is a need for more comparisons with short to medium half-life BZDs for the treatment of insomnia to show that zolpidem has any advantages over the BZDs. One placebo-controlled, randomized polysomnographic study of 24 patients with chronic insomnia found that zolpidem (10 mg) was comparable with triazolam (0.5 mg) and superior to placebo in enhancing sleep efficacy. Further, rebound insomnia occurred during the posttreatment, 3-day withdrawal phase in the triazolam group, but not in the zolpidem or the placebo groups (149). 

Zaleplon and zolpidem have been compared in two concurrent multicenter, randomized, double-blind, placebo-controlled crossover studies in chronic insomniacs (12). In study 1, zaleplon 10 mg, zolpidem 10 mg, or placebo were given double-bhnd to 36 healthy subjects under standardized conditions in a six-period, incomplete-block, crossover study (13). The subjects were gently awakened and given the medication at predetermined times, 5, 4, 3, or 2 hours before morning awakening, which occurred 8 hours after bedtime. When they awoke in the morning, subjective and objective assessments of residual effects of hypnotics were administered. There were no serious adverse experiences during the study all adverse events were mild to moderate. The most commonly reported adverse events associated with zaleplon were weakness and somnolence. Weakness, depersonalization, dizziness, and somnolence were the most frequent nervous system adverse events associated with zolpidem. 

In a double-blind, placebo-controlled, crossover study, 10 patients with probable progressive supranuclear palsy took single oral doses of zolpidem (5 and 10 mg), co-... 

In a double-blind, placebo-controlled, crossover study, 10 patients with probable progressive supranuclear palsy took single oral doses of zolpidem (5 and 10 mg), co-careldopa (levodopa 250 mg plus carbidopa 25 mg), or placebo in four separate trials in random order (10). Zolpidem, unlike levodopa or placebo, reduced voluntary saccadic eye movements, and the 5 mg dose produced a statistically significant improvement in motor function. The adverse effects of zolpidem included drowsiness and... 

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study compared the next-day residual effects, hypnotic efficacy, and sleep staging effects of fluraz-epam (30 mg) and zolpidem (10 and 20 mg) with those of placebo in patients with chronic insomnia. 

In a double-blind, randomized, placebo-controlled, three-way crossover study of the effect of ramelteon on middle-of-the-night balance, mobility, and memory in 33 older adults (age >65 years), zolpidem 10 mg was used as a positive control [25 ]. The subjects took the study medication 30 minutes before bedtime and were awakened 2 hours after dosing to assess balance, turning speed and stabihty, memory... 

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