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Restoril (Temazepam) - Summary



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.

See all Restoril indications & dosage >>


Media Articles Related to Restoril (Temazepam)

Talk Therapy May Help Ease Insomnia, Even With Other Health Woes
Source: MedicineNet Sleep Specialty [2015.07.17]
Title: Talk Therapy May Help Ease Insomnia, Even With Other Health Woes
Category: Health News
Created: 7/17/2015 12:00:00 AM
Last Editorial Review: 7/17/2015 12:00:00 AM

Cognitive behavioral therapy for insomnia with psychiatric, medical conditions
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2015.07.06]
Cognitive behavioral therapy is a widely used nonpharmacologic treatment for insomnia disorders and an analysis of the medical literature suggests it also can work for patients whose insomnia is...

Insomnia leads to decreased empathy in health care workers
Source: Caregivers / Homecare News From Medical News Today [2015.06.10]
Study highlights the importance to evaluate and treat insomnia in health care workersA new study suggests that insomnia decreases empathy in health care workers and may lead to adverse clinical...

73% of insomniacs cured after 1-hour therapy session
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2015.06.02]
A simple one-hour therapy session has helped to cure 73% of people suffering from acute insomnia, according to a new study from Northumbria University.

Source: MedicineNet Creutzfeldt-Jakob Disease 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

more news >>

Published Studies Related to Restoril (Temazepam)

Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. [2010.04]
BACKGROUND: Benzodiazepines can improve sleep quality, but are also thought to cause respiratory depression in patients with chronic obstructive pulmonary disease (COPD). The aims of this study were to assess the effects of temazepam on indices of circadian respiratory function, dyspnea, sleep quality, and sleepiness in patients with severe COPD and insomnia... CONCLUSIONS: One week usage of temazepam 10mg does not influence circadian respiratory function, dyspnea, and sleepiness in patients with stable, severe, normocapnic COPD and insomnia and it improves total sleep time and subjective sleep latency. However, this is a preliminary explorative study for assessing the feasibility to perform a larger study on this topic. The clinical implications of this study are very limited. Copyright 2009 Elsevier Ltd. All rights reserved.

Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. [2010]
in patients with severe COPD and insomnia... CONCLUSIONS: One week usage of temazepam 10mg does not influence circadian

Highway driving in the elderly the morning after bedtime use of hypnotics: a comparison between temazepam 20 mg, zopiclone 7.5 mg, and placebo. [2009.10]
A major problem related to hypnotic drug use is residual sedation the morning after bedtime administration. This constitutes a particular safety hazard for patients who have to drive a car the next morning... The magnitude of impairing effects in the elderly was comparable with those found previously in younger volunteers.

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.

more studies >>

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.

Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle [Recruiting]
Periocular blockade with 12. 5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.

SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy [Recruiting]
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of SAR 1118 within the anterior and posterior chamber of the eye and plasma in subjects undergoing elective vitrectomy when treated with escalating concentrations of the study drug for approximately 1 week.

more trials >>

Reports of Suspected Restoril (Temazepam) Side Effects

Insomnia (14)Anxiety (13)Pain (11)Fall (11)Nausea (11)Confusional State (10)Constipation (10)Gastrooesophageal Reflux Disease (10)Weight Decreased (9)Osteomyelitis (9)more >>


Based on a total of 5 ratings/reviews, Restoril has an overall score of 7.80. The effectiveness score is 8.40 and the side effect score is 8.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Restoril review by 47 year old female patient

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 56 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Sleeplessness
Dosage & duration:   10mg taken half a tab 3 times a month for the period of 3 years
Other conditions:   0
Other drugs taken:   HRT
Reported Results
Benefits:   Sometimes it makes the difference to stress- related sleeplessness.
Side effects:   I am aware that it is habit-forming, so I use it less often than I would like. If I take it late at night, I can feel sleepy next day
Comments:   Swollow half a pill.


Restoril review by 32 year old female patient

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.

See all Restoril reviews / ratings >>

Page last updated: 2015-07-17

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