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.

See all Restoril indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Restoril (Temazepam)

Relationship Between Sleep Duration And Suicidal Thoughts In People With Insomnia.
Source: Health News from Medical News Today [2013.05.17]
Results of a new study show that every one-hour increase in sleep duration was associated with a 72 percent decrease in the likelihood of moderate or high suicide risk, in comparison with low risk. Data were adjusted for age, gender, race/ethnicity, education and age of onset of sleep difficulties. "We were surprised by the strength of the association between sleep duration and suicide risk," said primary author Linden Oliver, MA, clinical research coordinator for the University of Pennsylvania Behavioral Sleep Medicine Research Program in Philadelphia, Pa...

Insomnia Can Lead To Future Hospitalization And Increased Health Service Use
Source: Seniors / Aging News From Medical News Today [2013.05.14]
Having trouble falling or staying asleep? According to a new study led by a team of researchers at the Johns Hopkins Bloomberg School of Public Health, insomnia may be an important indicator of future hospitalization among middle-aged and older adults...

A Woman's Risk Of Heart Disease May Be Increased By Insomnia And Disrupted Sleep During Menopause
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2013.05.13]
Insomnia and other sleep disturbances are common among perimenopausal and postmenopausal women and may increase their risk of coronary heart disease (CHD) and cardiovascular disease (CVD)...

Making Sense Of The Neurobiology Of Restless Legs Syndrome And Related Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2013.05.09]
Johns Hopkins researchers believe they may have discovered an explanation for the sleepless nights associated with restless legs syndrome (RLS), a symptom that persists even when the disruptive, overwhelming nocturnal urge to move the legs is treated successfully with medication...

Insomnia May Raise Risk of Heart Attack, Stroke
Source: MedicineNet Hyperthyroidism Specialty [2012.11.05]
Title: Insomnia May Raise Risk of Heart Attack, Stroke
Category: Health News
Created: 11/4/2012 8:35:00 PM
Last Editorial Review: 11/5/2012 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 [Recruiting]
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.

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.

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 >>

PATIENT REVIEWS / RATINGS / COMMENTS

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 56 year old female patient
		Rating
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
		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.