SONATA SUMMARY
Controlled Trials Supporting Effectiveness
Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class.
Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings.
Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks. Sonata should not be prescribed in quantities exceeding a 1-month supply (see WARNINGS).
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NEWS HIGHLIGHTSMedia Articles Related to Sonata (Zaleplon)
Stress, Bad Bedtime Habits Cause Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.07.27]
Title: Stress, Bad Bedtime Habits Cause Insomnia
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009
Pills Plus Psychotherapy Can Beat Insomnia
Source: MedicineNet Sleep Aids And Stimulants Specialty [2009.05.20]
Title: Pills Plus Psychotherapy Can Beat Insomnia
Category: Health News
Created: 5/20/2009 2:00:00 AM
Last Editorial Review: 5/20/2009
Insomnia
Source: MedicineNet Biorhythms Specialty [2009.03.03]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005
Last Editorial Review: 3/3/2009
Insomnia Treatment: Sleep Aids and Stimulants
Source: MedicineNet Narcolepsy Specialty [2009.01.14]
Title: Insomnia Treatment: Sleep Aids and Stimulants
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 1/14/2009
Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet temazepam Specialty [2008.06.05]
Title: Ten Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005
Last Editorial Review: 6/5/2008
Published Studies Related to Sonata (Zaleplon)
Zaleplon and zolpidem objectively alleviate sleep disturbances in mountaineers at a 3,613 meter altitude. [2007.11.01]
STUDY OBJECTIVES: To assess the effects of zolpidem and zaleplon on nocturnal sleep and breathing patterns at altitude, as well as on daytime attention, fatigue, and sleepiness... CONCLUSIONS: Both zolpidem and zaleplon have positive effects on sleep at altitude without adversely affecting respiration, attention, alertness, or mood. Hence, they may be safely used by climbers.
Sleep and residual sedation after administration of zaleplon, zolpidem, and placebo during experimental middle-of-the-night awakening. [2006.10.15]
STUDY OBJECTIVES: To assess the efficacy of zaleplon 10 mg and zolpidem 10 mg administered during experimental middle-of-the-night awakenings in patients with sleep-maintenance insomnia using objective polysomnographic measures and to assess daytime residual sedation 4 to 7 hours after dosing using sleep-latency testing... CONCLUSIONS: Zaleplon 10 mg and zolpidem 10 mg effectively shorten sleep latency and lengthen sleep duration after dosing, when administered during experimental nocturnal awakening. Residual sedation was not detected as little as 4 hours after zaleplon 10 mg, whereas residual sedation was detected with zolpidem 10 mg up to 7 hours after treatment. These findings suggest that zaleplon may be an appropriate treatment for use when patients awaken during the night and have difficulty reinitiating sleep.
High-performance liquid chromatography-atmospheric pressure chemical ionisation-mass spectrometry determination of zaleplon in human plasma. [2006.02.24]
A sensitive and specific liquid chromatography-atmospheric pressure chemical ionisation-mass spectrometry (LC-APCI-MS) method has been developed and validated for the identification and quantification of zaleplon in human plasma using estazolam as an internal standard (IS)...
Zaleplon (Sonata) oral sedation for outpatient third molar extraction surgery. [2005.01]
Zalpelon was compared with triazolam for oral sedation in a third molar surgery model using a double-blind crossover design. Factors such as anxiolysis, amnesia, and quality of sedation were assessed.Of the 14 participants who completed the study, zaleplon sedation was found to be similar to triazolam sedation in all regards except that recovery from zaleplon was more rapid.
Sleep-inducing pharmaceuticals: a comparison of melatonin, zaleplon, zopiclone, and temazepam. [2004.06]
CONCLUSIONS: The sleep-inducing power of the medications before psychomotor testing was zopiclone > zaleplon > melatonin > temazepam. The corresponding effect after psychomotor testing was zopiclone > melatonin > zaleplon > temazepam.
Clinical Trials Related to Sonata (Zaleplon)
Pharmacokinetics of Staccato Zaleplon [Completed]
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions [Completed]
The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon
Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions [Completed]
The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon
Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
Study of Sleep-Maintenance Activity of 3 Doses of SKP-1041 [Not yet recruiting]
SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is
currently available as Sonata as well as several generic formulations. Sonata and its
generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is
designed to become active 2-3 hours after ingestion. It is intended for use in people who
have no trouble falling to sleep but who often awaken in the middle of the night. This
trial will determine the best dose to prevent those awakenings.
Measurement of Cerebral Oxygen Extraction Fraction Using MRI Technique [Recruiting]
All images in this study were acquired on a 1. 5 T Sonata whole body scanner (Siemens Medical
Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D
single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility
contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen
utilization were calculated and plotted in all subjects.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Sonata has an overall score of 9. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Sonata review by 63 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | wakefulness -- difficulty falling back asleep |
| Dosage & duration: | | 10 mg taken once a week for the period of last 5 years |
| Other conditions: | | osteopenia |
| Other drugs taken: | | Boniva | | |
Reported Results |
| Benefits: | | I was able to go back to sleep after waking and then to get up in two hours without any grogginess or after effects. The sleep I had as a result of the pill was very restful. This drug allows you to take a pill in the early morning hours, go back to sleep and then get up at the normal time without any sort of hangover. It is wonderful. |
| Side effects: | | Better sleep. |
| Comments: | | Upon waking and not being able to return to sleep, one 10 mg dose of Sonata will return the patient to sleep. If used too frequently, I understand that the product will be ineffective. |
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| | Sonata review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Insomnia |
| Dosage & duration: | | .5 mg taken 1/night for the period of 8 weeks |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Fell asleep easily without feeling drugged the next day. |
| Side effects: | | None, but the drug didn't last long. It guaranteed I'd get about 5 hours sleep, no more. |
| Comments: | | Was having chronic insomnia, but I wanted a very mild sleep aid as I need to be very alert in my workday. I was able to get myself into a good sleep pattern without any drug dependence. |
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Page last updated: 2009-07-27
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