Zolpidem comparative studies

Salin-Pascual R. J. (2005). Comparative study between mirtazapine vs. zolpidem in isomnia associated with major depression management. Rev. Mex. Neurosci. 6, 212-17. 

Zolpidem 10 mg/day and zopiclone 7.5 mg/day, given at night, have been compared in a 14-day, double-blind study in 479 chronic primary insomniacs (17). With zolpidem 68% of the patients were rated at least moderately improved, versus 62% with zopiclone. However, with zolpidem sleep-onset latency improved in significantly more patients (86 versus 78%). In addition, significantly fewer patients who took zolpidem had drug-related adverse events (31 versus 45%) bitter taste accounted for 5.8% of such complaints with zolpidem compared with 40% with zopiclone. In conclusion, zolpidem was at least as effective as zopiclone but showed significantly less rebound on withdrawal overall it was better tolerated. 

Tsutsui SZolipidem Study Group. A double-blind comparative study of zolpidem versus zopiclone in the treatment of chronic primary insomnia. J Int Med Res 2001 29(3) 163-77. 

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). 

During the course of a study of the salts formed by saccharin with quinine, haloperidol, mirtazapine, pseudoephedrine, lamivudine, risperidone, sertraline, venlafaxine, zolpidem, and amlodipine, a 1 1 cocrystal of saccharin and piroxicam was detected [68]. In the crystal structure, the asymmetric unit was found to consist of one saccharin molecule and one zwitterionic piroxicam molecule that were linked by two sets of N—H O hydrogen bonds. The piroxicam-saccharin synthons were in turn linked through bridging C—H O hydrogen bonds. Interestingly, the drug substance solubility out of the cocrystal was found to be comparable to that of the marketed piroxicam product. 

The PSG withdrawal effects of zopiclone (7.5 mg), zolpidem (10 mg) and triazolam (0.25 mg) as compared with placebo were studied in 38 healthy subjects over 4 weeks [33], Slight, non-significant rebound effects on sleep continuity were detected after withdrawal of zopiclone and zolpidem. Total sleep time and sleep efficiency were lower the first night after cessation of triazolam. 

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. 

Zolpidem 10 mg, temazepam 15 mg, and placebo have been compared in 630 healthy adults in a multicenter study (15). They were given 15 minutes before lights... 

Flunitrazepam in a 2-mg dose was compared with zolpidem in a 20-mg dose. Forty-two insomniac female in-patients between 30 and 65 years of age were included in a doubleblind, parallel group trial and were randomly allocated to the two treatments. Study duration was 9 days with 2 days of placebo run-in, 5 days of active medication, and 2 days of placebo withdrawal. Sleep latency, sleep dura-... 

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. 

Triazolam was compared with zolpidem and placebo in a double-blind randomized study in elderly insomniacs. The patients received zolpidem (5 mg 70 patients), zolpidem (10 mg 74 patients), or triazolam (0.25 mg 77 patients). The 3-week active treatment period was preceded by 3 days and followed by 7 days of placebo administration. Both patients and clinicians evaluated sleep quality. The improvements between the end of placebo phase and the end of the active treatment phase were significant for all treatments. Overall evaluation indicated that zolpidem and triazolam are both effective in geriatric insomniac patients (98). 

Drug formulation Efficacy of sublingual zolpidem (5 and 10 mg) was compared to oral zolpidem 10 mg in an open-label, randomised, double-blind, controlled trial in 58 healthy volimteers [20 ]. This study found that people who had sublingual zolpidem, 5 mg or 10 mg, had an earlier sleep onset compared to those who had oral zolpidem 10 mg (p < 0.005). There was no significant difference between the effects of the 5 mg and the 10 mg doses sublingual in sleep initiation. 

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