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SONATA (ZALEPLON): CLINICAL TRIALS
Controlled Trials Supporting Effectiveness
Sonata (typically administered in doses of 5, 10, or 20 mg) has been studied in patients with chronic insomnia (n = 3,435) in 12 placebo- and active-drug controlled trials. Three of the trials were in elderly patients (n = 1,019). It has also been studied in transient insomnia (n=264). Because of its very short halflife, studies focused on decreasing sleep latency, with less attention to duration of sleep and number of awakenings, for which consistent differences from placebo were not demonstrated. Studies were also carried out to examine the time course of effects on memory and psychomotor function, and to examine withdrawal phenomena.
Normal adults experiencing transient insomnia during the first night in a sleep laboratory were evaluated in a double-blind, parallel-group trial comparing the effects of two doses of Sonata (5 and 10 mg) with placebo. Sonata 10 mg, but not 5 mg, was superior to placebo in decreasing latency to persistent sleep (LPS), a polysomnographic measure of time to onset of sleep.
Adult outpatients with chronic insomnia were evaluated in three double-blind, parallel-group outpatient studies, one of 2-weeks duration and two of 4-weeks duration, that compared the effects of Sonata (Zaleplon) capsules at doses of 5 (in two studies), 10, and 20 mg with placebo on a subjective measure of time to sleep onset (TSO). Sonata 10 and 20 mg were consistently superior to placebo for TSO, generally for the full duration of all three studies. Although both doses were effective, the effect was greater and more consistent for the 20-mg dose. The 5-mg dose was less consistently effective than were the 10- and 20-mg doses. Sleep latency with Sonata 10 and 20 mg was on the order of 10-20 minutes (15%-30%) less than with placebo in these studies.
Adult outpatients with chronic insomnia were evaluated in six double-blind, parallel-group sleep laboratory studies that varied in duration from a single night up to 35 nights. Overall, these studies demonstrated a superiority of Zaleplon (Sonata) capsules 10 and 20 mg over placebo in reducing LPS on the first 2 nights of treatment. At later time points in 5-, 14-, and 28-night studies, a reduction in LPS from baseline was observed for all treatment groups, including the placebo group, and thus, a significant difference between Sonata and placebo was not seen beyond 2 nights. In a 35-night study, Sonata 10 mg was significantly more effective than placebo in reducing LPS at the primary efficacy endpoint on nights 29 and 30.
Elderly outpatients with chronic insomnia were evaluated in two 2-week, double-blind, parallel-group outpatient studies that compared the effects of Sonata (Zaleplon) 5 and 10 mg with placebo on a subjective measure of time to sleep onset (TSO). Sonata at both doses was superior to placebo on TSO, generally for the full duration of both studies, with an effect size generally similar to that seen in younger persons. The 10-mg dose tended to have a greater effect in reducing TSO.
Elderly outpatients with chronic insomnia were also evaluated in a 2-night sleep laboratory study involving doses of 5 and 10 mg. Both 5- and 10-mg doses of Zaleplon (Sonata) were superior to placebo in reducing latency to persistent sleep (LPS).
Generally in these studies, there was a slight increase in sleep duration, compared to baseline, for all treatment groups, including placebo, and thus, a significant difference from placebo on sleep duration was not demonstrated.
Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs
Studies involving the exposure of normal subjects to single fixed doses of Sonata (10 or 20 mg) with structured assessments of short-term memory at fixed times after dosing (eg, 1, 2, 3, 4, 5, 8, and 10 hours) generally revealed the expected impairment of short-term memory at 1 hour, the time of peak exposure to zaleplon, for both doses, with a tendency for the effect to be greater after 20 mg. Consistent with the rapid clearance of zaleplon, memory impairment was no longer present as early as 2 hours post dosing in one study, and in none of the studies after 3-4 hours. Nevertheless, spontaneous reporting of adverse events in larger premarketing clinical trials revealed a difference between Sonata and placebo in the risk of next-day amnesia (3% vs 1%), and an apparent dose-dependency for this event.
Studies involving the exposure of normal subjects to single fixed doses of Sonata (10 or 20 mg) with structured assessments of sedation and psychomotor function (eg, reaction time and subjective ratings of alertness) at fixed times after dosing (eg, 1, 2, 3, 4, 5, 8, and 10 hours) generally revealed the expected sedation and impairment of psychomotor function at 1 hour, the time of peak exposure to zaleplon, for both doses. Consistent with the rapid clearance of zaleplon, impairment of psychomotor function was no longer present as early as 2 hours post dosing in one study, and in none of the studies after 3-4 hours. Spontaneous reporting of adverse events in larger premarketing clinical trials did not suggest a difference between Sonata (Zaleplon) capsules and placebo in the risk of next-day somnolence.
Withdrawal Emergent Anxiety and Insomnia
During nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug or its active metabolites (ie, in relationship to the receptor site) may occur at some point in the interval between each night's use. This sequence of events is believed to be responsible for two clinical findings reported to occur after several weeks of nightly use of other rapidly eliminated hypnotics: increased wakefulness during the last quarter of the night and the appearance of increased signs of daytime anxiety.
Zaleplon (Sonata) capsules have a short half-life and no active metabolites. At the primary efficacy endpoint (nights 29 and 30) in a 35-night sleep laboratory study, polysomnographic recordings showed that wakefulness was not significantly longer with Sonata than with placebo during the last quarter of the night. No increase in the signs of daytime anxiety was observed in clinical trials with Sonata. In two sleep laboratory studies involving 14 and 28 nightly doses of Sonata (5 and 10 mg in one study and 10 and 20 mg in the second) and structured assessments of daytime anxiety, no increases in daytime anxiety were detected. Similarly, in a pooled analysis (all the parallel-group, placebo-controlled studies) of spontaneously reported daytime anxiety, no difference was observed between Sonata and placebo.
Rebound insomnia, defined as a dose-dependent temporary worsening in sleep parameters (latency, total sleep time, and number of awakenings) compared to baseline following discontinuation of treatment, is observed with short- and intermediate-acting hypnotics. Rebound insomnia following discontinuation of Zaleplon (Sonata) relative to baseline was examined at both nights 1 and 2 following discontinuation in three sleep laboratory studies (14, 28, and 35 nights) and five outpatient studies utilizing patient diaries (14 and 28
nights). Overall, the data suggest that rebound insomnia may be dose dependent. At 20 mg, there appeared to be both objective (polysomnographic) and subjective (diary) evidence of rebound insomnia on the first night after discontinuation of treatment with Sonata. At 5 and 10 mg, there was no objective and minimal subjective evidence of rebound insomnia on the first night after discontinuation of treatment with Sonata.
At all doses, the rebound effect appeared to resolve by the second night following withdrawal. In the 35-night study, there was a worsening in sleep on the first night off for both the 10- and 20-mg groups compared to placebo, but not to baseline. This discontinuation-emergent effect was mild, had the characteristics of the return of the symptoms of chronic insomnia, and appeared to resolve by the second night after zaleplon discontinuation.
Other Withdrawal-Emergent Phenomena
The potential for other withdrawal phenomena was also assessed in 14 to 28 night studies, including both the sleep laboratory studies and the outpatient studies, and in open-label studies of 6- and 12-month durations. The Benzodiazepine Withdrawal Symptom Questionnaire was used in several of these studies, both at baseline and then during days 1 and 2 following discontinuation. Withdrawal was operationally defined as the emergence of 3 or more new symptoms after discontinuation. Sonata was not distinguishable from placebo at doses of 5, 10, or 20 mg on this measure, nor was Sonata distinguishable from placebo on spontaneously reported withdrawal-emergent adverse events. There were no instances of withdrawal delirium, withdrawal associated hallucinations, or any other manifestations of severe sedative/hypnotic withdrawal.
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