Zolpidem

Zolpidem is sold in the United States under the name Ambien. Zolpidem tartrate is a drug of the hypnotic class that resembles a benzodiazepine drug.

The medicine induces deep sleep and does not have the muscle relaxant or anticonvulsant properties of benzodiazepine drugs.

Zolpidem
Zolpidem, a GABAA receptor agonist, is indicated for the management of insomnia. The most common complaint among patients with insomnia is difficulty staying asleep. In order to address this population more directly, a modified-release (MR) zolpidem formulation has been developed that incorporates both immediate-release (IR) and prolonged-release preparations. The MR formulation provides sustained plasma zolpidem concentrations in the middle portion of the night (3-6 hours post dose) to improve sleep maintenance, even though it has the same elimination half-life as standard zolpidem.

To determine which formulation of zolpidem MR provides the optimal duration of sleep maintenance without residual effects, Hindmarch and colleagues[11] report the results of a randomized, double-blind placebo- and standard-dose zolpidem (10 mg) controlled, crossover, pharmacodynamic study of 8 zolpidem MR formulations. The study employed a traffic noise model of insomnia in 32 subjects undergoing nocturnal polysomnography. Two particular formulations, including the "E" (12.5-mg) formulation, significantly reduced the total night number of awakenings when compared with placebo and standard zolpidem. In order to investigate the time course of hypnotic action, awakenings were also analyzed on a per-hour basis. All formulations significantly reduced the number of awakenings up to 3 hours after sleep onset. Three formulations, including E, were also effective for 5 hours when compared with placebo. Standard zolpidem and 3 of the MR formulations, including E, showed no evidence of residual effects in psychometric/cognitive tests. The MR formulation promises to be superior to standard zolpidem for the treatment of sleep-maintenance insomnia, with no additional negative effects on daytime performance.

A major challenge for clinicians is the uncertainty of how long hypnotics should be used by chronic insomnia sufferers. To address this concern, Perlis and colleagues[12] from 9 centers reported data on 199 patients (mean age, 41 ± 12.8 years; 71% women) who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for primary insomnia. They were randomized in a double-blind, placebo-controlled fashion to either 10 mg of zolpidem nonnightly or placebo for 12 weeks. Compared with placebo, the medication demonstrated significant improvements in subjective sleep latency (SL), the number of awakenings, WASO, and TST. The maintenance of clinical gains over the 3-month study interval suggests that, in the absence of dose escalation, habituation and tolerance do not occur with chronic intermittent use of zolpidem. Another analysis of the same data[13] indicated that patients did not escalate zolpidem medication intake, as compared with the placebo group. Participants using zolpidem voluntarily limited use to 80% of available medication. Increases in use represented only 20% of the possible increase, and this trend did not differ from that of the patients taking placebo.

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"Sleep hath seized me wholly"

(William Shakespeare – Cymebline)