RESTORIL NEWS HIGHLIGHTS Media Articles Related to Restoril (Temazepam)
Mylan Receives FDA Approval For Additional Strength Of Generic Restoril(R)
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.26]
Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths of the product. Temazepam Capsules are the generic version of Mallinckrodt's Restoril®, a sleep aid, which had total U.S.
Scientists Search For Sleepless Souls Suffering Lifelong Insomnia, Scotland
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.21]
Most people have experienced the odd sleepless night before a crucial exam, a job interview or before going on holiday, but few people get by with just a couple of hours of sleep a day, every day. Terry McKinnes, 54, of Falkirk, is one of the unfortunate people who suffers from idiopathic insomnia who feels she has spent almost her entire life awake.
APSS: Nonsedating Sleep Aid Improves Insomnia and Performance (CME/CE)
Source: MedPage Today Psychiatry [2009.06.18]
SEATTLE (MedPage Today) -- An investigational nonsedating medication improved sleep maintenance without residual next-day effects in a placebo-controlled trial of patients with chronic insomnia.
Frontal Cerebral Hypothermia Found To Be Possible New Treatment For Insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.14]
Insomnia is associated with increased frontal cerebral metabolism during Rapid Eye Movement (REM) sleep. Cerebral hypothermia, or cooling of the brain, has been found to reduce cerebral metabolism in other medical conditions, but its effects in insomnia are unknown. In a University of Pittsburgh study by Eric Nofzinger, M.D.
Neurim Pharmaceuticals Reports Long Term Efficacy And Safety For Circadin(R) For Insomnia In Elderly Patients
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.12]
Neurim Pharmaceuticals presented the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, (APSS) held at Seattle, Washington. The SLEEP meeting attracts the largest audience of sleep specialists in world.
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 [generic for Restoril], 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 [generic for Restoril] 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 [generic for Restoril] 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 [generic for Restoril] 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 [generic for Restoril], 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.
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.
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.
Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema [Recruiting]
To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and
visual acuity in patients with diffuse diabetic macular edema and their relation to renal
disease.
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