Rosenberg and colleagues conducted a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of a one-time dose of eszopi-clone using the “first-night effect” model of transient insomnia. The first-night effect refers to the insomnia that commonly occurs when someone is assessed in a sleep laboratory.
A total of 436 adults aged 25 to 50 years were randomly assigned to receive either placebo or eszopiclone 1, 2, 3, or 3.5 mg. Participants had to have a body mass index between 16 and 30 kg/m, no history of insomnia, and a report of normal sleep patterns. viagra uk online
Participants were excluded from the study if they:
- had previously slept in a sleep laboratory.
- had symptoms of a primary sleep disorder.
- had a known hypersensitivity to zopiclone or other hypnotic agents.
- had any unstable medical conditions or a history of psychiatric problems.
Participants were instructed to avoid taking any over-the-counter analgesics within seven days of the study or any other medication within 14 days, and they were required not to have used tobacco or nicotine products within the previous three months. Caffeine intake was limited to 180 mg daily, and no caffeine or alcohol was allowed after 2 p.m. on the day of the study.
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The primary endpoint was latency to persistent sleep (LPS), as measured objectively by polysomnography. LPS was defined as the time from “lights out” (bedtime) to the beginning of 10 uninterrupted minutes of sleep. Objective secondary measures included:
- wake time (the time spent awake during undesired awakenings) after initial sleep onset.
- sleep efficiency.
- the number of awakenings lasting at least one minute.
- sleep architecture (the stages and cycles of sleep).
All of these measures were obtained via polysomnography. Subjective measures were also obtained from the patients, including quality of sleep and depth of sleep. Safety was assessed via clinical laboratory tests, electrocardiograms, vital signs, physical and neurological examinations, and the occurrence of ADEs. viagra soft
A total of 436 patients were randomly selected to receive either placebo or eszopiclone 1, 2, 3, or 3.5 mg. The baseline characteristics were similar for all five groups. Subjects who received 2, 3, and 3.5 mg had a statistically significant shorter LPS compared with those receiving placebo (P < .0001). For those taking eszopiclone 1 mg, the LPS was reduced but did not different significantly from that in the placebo group (P= .06).
The wake time after sleep onset was significantly reduced in all patients taking eszopiclone compared with that in those taking placebo (P < .05). The number of awakenings was significantly decreased with eszopiclone 3 and 3.5 mg compared with placebo (P< .005). Sleep efficiency, or total sleep time, significantly increased in all eszopiclone patients compared with placebo patients (P< .02).
Self-reported total sleep time increased significantly in the patients taking 2, 3, and 3.5 mg compared with the placebo patients (P < .01). More patients treated with eszopiclone reported deep or very deep sleep compared with the placebo subjects (P < .01). All of the study drug groups, except for those taking 1 mg, reported good or excellent quality of sleep compared with the placebo group (P < .0001). However, more patients in the 3- and 3.5-mg treatment groups reported morning drowsiness compared with those in the placebo group (P< .05).
Sleep architecture did not change significantly in any of the treatment groups, except with eszopiclone 3.5 mg, when compared with placebo. The 3.5-mg group experienced a statistically significant decrease in total time spent in non-rapid-eye movement (NREM) stage 1 sleep and rapid-eye movement (REM) sleep, as well as a statistically significant increase in time spent in NREM stage 2 (P < .05) sleep. Stages 3 and 4, which are the restorative stages of sleep, did not change significantly in any of the treatment groups.
The most commonly reported ADEs with all doses were headache, somnolence, and unpleasant taste. Dizziness was reported more often with the patients who received 3.5 mg of eszopi-clone. An unpleasant taste was the only ADE reported with more frequency in the eszopiclone groups (range, 17.021.6%) than in the placebo group (7.1%). There were no abnormal laboratory parameters, vital signs, or electrocardio-graphic changes.
The authors concluded that the doses of 2 and 3 mg were the most effective for treating transient insomnia without affecting sleep structure or causing next-day drowsiness.
The average wholesale price (AWP) of a month’s supply of eszopiclone 1-mg tablets is $111. The price is the same for the 2- and 3-mg tablets. This charge may vary according to acquisition costs in different health care systems.
The other leading hypnotic agent, zolpidem (Ambien™, Sanofi-Synthelabo), is less expensive ($78.90 for a month’s supply of 5-mg tablets and $96.70 for the 10-mg tablets). The AWP of zaleplon (Sonata™, Wyeth) is $74.40 for a month’s supply of 5-mg capsules and $91.50 for the 10-mg capsules.
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Further research is needed to compare these drugs and to determine whether the higher cost of eszopiclone is rational. Because all three drugs have a similar mechanism of action, one would not expect much difference in their efficacy.
The advantages of eszopiclone include its quick onset and proper duration of action, little next-day residual drowsiness, and a low incidence of ADEs. This agent is unique among the sedativehypnotics, in that the FDA has not limited its use in the short-term treatment of insomnia. However, caution must be used when treating insomnia chronically with an oral medication. True primary insomnia is rare. Insomnia is often the result of another underlying untreated medical condition or psychiatric illness. Physicians and pharmacists should conduct a thorough assessment of a patient’s complaint of insomnia before prescribing any sedative-hypnotics.