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Sonata (Zaleplon) - Summary

 
 



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).


See all Sonata indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Sonata (Zaleplon)

Can insomnia be treated with two weeks in a specialized hospital?
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2014.09.05]
Insomnia is a disturbance that afflicts many people. Some new findings published in Psychotherapy and Psychosomatics indicate that a two week stay in a specialized hospital may help.

Morning Break: The Incredible Shrinking Insomniac Brain
Source: MedPage Today Psychiatry [2014.09.05]
(MedPage Today) -- Health news and commentary from around the Web, gathered by the MedPage Today staff.

10 Tips to Avoid Insomnia and Get a Good Night's Sleep
Source: MedicineNet Sleep Aids And Stimulants Specialty [2014.07.18]
Title: 10 Tips to Avoid Insomnia and Get a Good Night's Sleep
Category: Doctor's Views
Created: 6/14/2005 12:00:00 AM
Last Editorial Review: 7/18/2014 12:00:00 AM

Insomnia
Source: MedicineNet Biorhythms Specialty [2014.07.17]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005 12:00:00 AM
Last Editorial Review: 7/17/2014 12:00:00 AM

Insomnia Treatment (Sleep Aids and Stimulants)
Source: MedicineNet Jet Lag Specialty [2014.07.17]
Title: Insomnia Treatment (Sleep Aids and Stimulants)
Category: Diseases and Conditions
Created: 9/24/1999 7:06:00 AM
Last Editorial Review: 7/17/2014 12:00:00 AM

more news >>

Published Studies Related to Sonata (Zaleplon)

A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia. [2011.01]
BACKGROUND: Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia... CONCLUSION: There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.

Pharmacokinetic profile of SKP-1041, a modified release formulation of zaleplon. [2011]
modified-release preparation of zaleplon (SKP-1041)... CONCLUSIONS: Zaleplon, 15 mg, in a novel, modified-release formulation (SKP-1041)

A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia. [2011]
effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia... CONCLUSION: There was no significant difference between zaleplon and zolpidem in

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.

more studies >>

Clinical Trials Related to Sonata (Zaleplon)

Safety Study of Lifitegrast to Treat Dry Eye [Recruiting]
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Dual Release Zaleplon AP (Zaleplon Accordion Pill) to Placebo in Subjects With Insomnia [Recruiting]
This is a multi center, double blind placebo controlled, three-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing 2 formulations of the Zaleplon AP to placebo.

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

Hypnotic Medications and Memory: Effect of Drug Exposure During the Night [Not yet recruiting]
The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.

more trials >>

Reports of Suspected Sonata (Zaleplon) Side Effects

Drug Ineffective (5)Death (3)Insomnia (3)Drug Screen False Positive (2)Victim of Sexual Abuse (1)Pruritus (1)Urticaria (1)Blood Thyroid Stimulating Hormone Increased (1)Erythema (1)Poor Quality Sleep (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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.

 

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.

See all Sonata reviews / ratings >>

Page last updated: 2014-09-05

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