Edluar (zolpidem tartrate)Company: Orexo
Approval Status: Approved March 2009
Treatment for: insomnia
Areas: Neurology & Nervous System; Psychiatry / Psychiatric
Edluar (zolpidem tartrate) is a sublingual non-benzodiazepine hypnotic of the imidazopyridine class. It interacts with a GABA-BZ receptor complex, found in the central and peripheral autonomic nervous system, by binding to gamma-aminobutyric acid (GABAA) receptors at the same location as benzodiazepines. Imidazopyridine are molecularly distinct from the classical benzodiazepine molecule and thus don't possess the potential adverse effects of the benzodiazepine class.Edluar is specifically indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Edluar is supplied as a 5 mg or 10 mg sublingual tablet designed for oral administration. The dose should be individualized. Hoeever, the recommended initial dose for adults is 10 mg once daily immediately before bedtime. The total Edluar daily dose should not exceed 10 mg. The recommended dose of Edluar in the elderly or debilitated population is 5 mg once daily immediately before bedtime. Edluar should not be given with or immediately after a meal. The sublingual tablet should be placed under the tongue and alowed to disintegrate. It should not be swallowed and should not be taken with water.
Clinical ResultsFDA Approval
The FDA approval of Edluar was based on several studies:
This double-blind, parallel group, 5-week trial enrolled 75 adult subjects with chronic insomnia. The subjects received two doses of zolpidem tartrate or placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.
This double-blind, parallel group, 4-week trial enrolled 141 adult subjects with chronic insomnia who received two doses of zolpidem or placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.
This double-blind, parallel group, single-night trial enrolled 462 adult subjects experiencing transient insomnia during the first night in a sleep laboratory. The subjects received two doses of zolpidem tartrate oral tablets (7.5 and 10 mg) or placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.
This double-blind, crossover, 2-night trial enrolled 35 elderly adults (mean age 68) experiencing transient insomnia during the first two nights in a sleep laboratory. The subjects received four doses of zolpidem (5, 10, 15 and 20 mg) or placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).
Edluar was also studied for the following latent effects.
Next-day residual effects
Seven studies enrolled normal adult subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of zolpidem tartrate in non-elderly patients with insomnia did not detect evidence of next-day residual effect.
In studies evaluating sleep on the nights following discontinuation of zolpidem tartrate, there was no objective (polysomnographic) evidence of rebound insomnia at the recommended doses.
Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the recommended administration of zolpidem tartrate.
Effects on sleep stages
In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.
Adverse events associated with the use of Edluar may include, but are not limited to, the following:
Mechanism of Action
Edluar (zolpidem tartrate) is a sublingual non-benzodiazepine hypnotic of the imidazopyridine class. It interacts with a GABA-BZ receptor complex, found in the central and peripheral autonomic nervous system, by binding to gamma-aminobutyric acid (GABAA) receptors at the same location as benzodiazepines. Imidazopyridine are molecularly distinct from the classical benzodiazepine molecule and thus don't possess the potential adverse effects of the benzodiazepine class.
Staner L, Eriksson M, Cornette F, Santoro F, Muscat N, Luthinger R, Roth T Sublingual zolpidem is more effective than oral zolpidem in initiating early onset of sleep in the post-nap model of transient insomnia: A polysomnographic study. Sleep Medicine 2008 Nov 7
Roth T, Hull SG, Lankford DA, Rosenberg R, Scharf MB; Intermezzo Study Group Low-dose sublingual zolpidem tartrate is associated with dose-related improvement in sleep onset and duration in insomnia characterized by middle-of-the-night (MOTN) awakenings. Sleep 2008 Sep 1;31(9):1277-84
Roth T, Mayleben D, Corser BC, Singh NN Daytime pharmacodynamic and pharmacokinetic evaluation of low-dose sublingual transmucosal zolpidem hemitartrate. Human Psychopharmacology 2008 Jan;23(1):13-20
Additional InformationFor additional information regarding Edluar or insomnia, please visit the Edluar web page.
Edluar Drug Information
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