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Sonata (Zaleplon) - Summary

 
 



SONATA SUMMARY

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)

Sleep biology discovery could lead to new insomnia treatments that don't target the brain
Source: Biology / Biochemistry News From Medical News Today [2017.08.14]
UCLA scientists report the first evidence that a gene outside the brain controls the ability to rebound from sleep deprivation - a surprising discovery that could eventually lead to greatly improved...

20 Tips to Beat Insomnia and Sleep Better
Source: MedicineNet Sleep Specialty [2017.07.26]
Title: 20 Tips to Beat Insomnia and Sleep Better
Category: Slideshows
Created: 10/1/2014 12:00:00 AM
Last Editorial Review: 7/26/2017 12:00:00 AM

Did Grandpa's Insomnia Serve an Evolutionary Purpose?
Source: MedicineNet Senior Health Specialty [2017.07.12]
Title: Did Grandpa's Insomnia Serve an Evolutionary Purpose?
Category: Health News
Created: 7/11/2017 12:00:00 AM
Last Editorial Review: 7/12/2017 12:00:00 AM

Review: Insomnia medication may wake up some patients from vegetative state
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2017.06.28]
In a new systematic review in JAMA Neurology, Michigan Medicine researchers found reason to further explore the surprising effects of zolpidem that have been observed outside the scope of its primary...

Valerian root for insomnia and anxiety: Does it work?
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2017.06.25]
Valerian root is considered to be safe and may be a gentler alternative to synthetic drugs for relief from anxiety and sleeplessness. Learn more.

more news >>

Published Studies Related to Sonata (Zaleplon)

The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. [2013]
Pharmacokinetics, pharmacodynamics, safety, and tolerability of inhaled zaleplon were assessed in healthy volunteers... Zaleplon inhalation represents a safe, well-tolerated means of rapidly achieving effective plasma concentrations.

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.

more studies >>

Clinical Trials Related to Sonata (Zaleplon)

Zaleplon 10mg Capsules Under Fasting Conditions [Completed]
The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.

Zaleplon 10 mg Capsules Under Non-Fasting Conditions [Completed]
The objective of this study is to compare the relative bioavailability of zaleplon 10 mg capsules(manufactured and distributed by TEVA Pharmaceuticals USA) with that of SONATA® 10mg capsules (Wyeth-Ayerst Pharmaceuticals) in healthy, non-smoking, adult subjects under non-fasting conditions.

Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 [Completed]
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.

A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia [Completed]
This is a multi center, double blind placebo controlled, two-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 to placebo.

Staccato Zaleplon Single Dose PK [Completed]

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: 2017-08-14

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