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Restoril (Temazepam) - Summary



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)

Insomnia Quiz: What Is Insomnia?
Source: MedicineNet Sleep Specialty [2017.09.19]
Title: Insomnia Quiz: What Is Insomnia?
Category: MedicineNet Quiz
Created: 6/6/2016 12:00:00 AM
Last Editorial Review: 9/19/2017 6:44:12 PM

20 Tips to Beat Insomnia and Sleep Better
Source: MedicineNet Sleep Aids And Stimulants 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

Source: MedicineNet Hyperthyroidism Specialty [2017.05.12]
Title: Insomnia
Category: Symptoms and Signs
Created: 7/28/2006 12:00:00 AM
Last Editorial Review: 5/12/2017 12:00:00 AM

Insomnia (Symptoms, Causes, Remedies, and Cures)
Source: MedicineNet Biorhythms Specialty [2017.04.19]
Title: Insomnia (Symptoms, Causes, Remedies, and Cures)
Category: Diseases and Conditions
Created: 6/6/2005 12:00:00 AM
Last Editorial Review: 4/19/2017 12:00:00 AM

Sleep Disorders: Insomnia, Sleep Apnea, and More
Source: MedicineNet modafinil Specialty [2016.08.22]
Title: Sleep Disorders: Insomnia, Sleep Apnea, and More
Category: Slideshows
Created: 7/23/2010 2:39:00 PM
Last Editorial Review: 8/22/2016 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)

Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude [Completed]
More than 70% of visitors to high altitude suffer poor sleep. The present study seeks to answer the question: Which medication is associated with better sleep at high altitude: temazepam or acetazolamide? The investigators hypothesis is that one medication will be associated with higher subjective sleep scores than the other. The study will compare the sleep quality of 100 subjects as they take either temazepam or acetazolamide during a visit to high altitude.

Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia [Completed]
The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks. This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.

Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women [Completed]
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.

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.

The Treatment of Insomnia in Patients With HIV Disease [Completed]
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

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: 2017-09-19

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