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Restoril (Temazepam) - Summary

 



RESTORIL SUMMARY

Restoril®
(temazepam)
capsules USP

Restoril® (temazepam) is a benzodiazepine hypnotic agent.

Restoril® (temazepam) is indicated for the short-term treatment of insomnia (generally 7-10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that Restoril® (temazepam) should be used for short periods of time (7-10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.


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NEWS HIGHLIGHTS

Media Articles Related to Restoril (Temazepam)

Novel Patent Targets The Most Common Sleep Complaint: Chronic Insomnia
Source: Health News from Medical News Today [2010.02.08]
Consolidated Research of Richmond, Inc. (CRI) announces the awarding of United States Patent 7,654,948 - which is a novel, drug-free system for treating people suffering from the most common sleep complaint: Chronic Insomnia. An estimated 10-20% of the industrialized world's adult population suffers from moderate to severe chronic insomnia, yet, unlike sleep apnea, there is a significant lack of technology addressing this tremendous need. Products based on Consolidated Research's patented technologies will address this market need. Source Consolidated Research of Richmond, Inc...


Somaxon Provides Update On New Drug Application For Silenor(R) For The Treatment Of Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2010.01.22]
Somaxon Pharmaceuticals, Inc...

Link Between Insomnia Symptoms And Medical Complaints In Young School-Aged Children
Source: Headache / Migraine News From Medical News Today [2009.12.15]
A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine indicates that significant associations exist between parent-reported insomnia symptoms and medical complaints of gastrointestinal regurgitation and headaches in young school-aged children. Results of multivariate regression analysis show that parent-reported insomnia was 3...

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

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Published Studies Related to Restoril (Temazepam)

Effects of 2-Week Treatment With Temazepam and Diphenhydramine in Elderly Insomniacs: A Randomized, Placebo-Controlled Trial. [2008.04]
A randomized, controlled, crossover clinical study compared 14-night treatment with 15 mg temazepam, 50 mg diphenhydramine, and placebo in elderly individuals with insomnia (mean age, 73.9 years; range, 70-89 years). Primary outcome measures were subjective assessments of sleep recorded on sleep diaries...

Temazepam at high altitude reduces periodic breathing without impairing next-day performance: a randomized cross-over double-blind study. [2006.12]
The aim of the study was to examine the efficacy and safety of temazepam on nocturnal oxygenation and next-day performance at altitude. A double-blind, randomized, cross-over trial was performed in Thirty-three healthy volunteers... We conclude that at high altitude temazepam is effective in reducing periodic breathing, and is safe to use, without any adverse effect upon next-day performance.

Usefulness of temazepam and zaleplon to induce afternoon sleep. [2006.10]
Insufficient daytime sleep may result in reduction of effectiveness and safety during overnight military missions. The usefulness of temazepam and zaleplon to optimize afternoon sleep and their effects on performance and alertness during a subsequent night shift were studied.

Selective effects of clonidine and temazepam on attention and memory. [2005.05]
The present study compared the effects of clonidine and temazepam on performance on a range of tasks aiming to assess the role of central noradrenergic mechanisms in cognitive function. Fifteen healthy volunteers (seven male, eight female), aged 18-25 years, took part in a five-period crossover study in which they received placebo, temazepam (15 and 30 mg) and clonidine (150 and 300 microg) by mouth in counterbalanced order in sessions at least 4 days apart...

Efficacy of temazepam in frequent users: a series of N-of-1 trials. [2005.04]
BACKGROUND: Benzodiazepines are frequently prescribed for sleep disturbances. However, benzodiazepines are associated with side effects, and may be ineffective when used for a prolonged period of time. OBJECTIVES: To investigate for individual patients whether placebo was as effective as temazepam, or whether 10 mg was as effective as 20 mg temazepam, and whether these results influenced their future temazepam use... CONCLUSION: The results regarding the efficacy of temazepam varied across patients. N-of-1 trials seem to be valuable in patients who are motivated to stop or reduce their temazepam use. They clearly demonstrate the efficacy of temazepam, and may give patients additional confidence to discontinue regular hypnotic use. The value of N-of-1 trials for patients who are less motivated is unclear, as the size of treatment effect does not seem to influence future hypnotic use.

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Clinical Trials Related to Restoril (Temazepam)

Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA) [Completed]
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease [Completed]
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease.

The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.

Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women [Recruiting]
This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers.

The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by a screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit.

Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase.

The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase.

Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status.

The primary study objective is to compare EEG power spectra during nonREM sleep in the slow-wave frequencies following administration with melatonin to temazepam.

20- Versus 23- Gauge System for Pars Plana Vitrectomy [Completed]
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.

The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.

Preoperative Bevacizumab for Vitreous Hemorrhage [Recruiting]
The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Restoril has an overall score of 7.50. The effectiveness score is 9 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
 

Restoril review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   10 mg taken once at night for the period of as needed
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Induces a pleasant intense relaxation. Fall asleep easily but not feel super doped up or hungover in the morning. Prevents laboriously resetting body clock after an all night binge.
Side effects:   none
Comments:   Taken usually after 2 am when it's pretty obvious I will be up all night if I don't and i can't afford to muck up my day by sleeping in! Taken just before retiring - enough time between swallowing the thing and the effects to safely brush teeth and get changed for bed, read a few pages of a book.

 

Restoril review by 32 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Insomnia
Dosage & duration:   10mg taken everyday for the period of A little over 2 weeks
Other conditions:   Lupus (SLE)
Other drugs taken:   Prednisolone, Azathiaprine, Plaquenil
  
Reported Results
Benefits:   Allowed me to fall asleep and stay asleep for the first week.
Side effects:   Drowsiness during the day, drowsiness and disorientation during the night after taking the tablet.
Comments:   I took one 10mg tablet every night and it was very effective for the first week or so. Then after the first week I found that one tablet wasn't very effective, I had trouble falling asleep and also woke up several times during the night. I took 2 tablets for the next few days and it worked well, but after that it wasn't working well anymore so I took 4 tablets one night. The sleep was very disturbed, I kept falling in and out of sleep all night, and felt extremely drowsy and disorientated. I discontinued the use of this drug immediately as I realized I had quickly built a tolerance to it and wasn't effective anymore, even with 40mg.

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Page last updated: 2010-02-08

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