CLINICAL TRIALS PROFILE FOR RESTORIL

All Clinical Trials for RESTORIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00330291 ↗	Xyrem for Treatment Refractory Insomnia Due to PTSD	Withdrawn	State University of New York - Upstate Medical University	Phase 2	2005-08-01	Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.
NCT01519544 ↗	Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude	Completed	Massachusetts General Hospital	N/A	2012-03-01	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.

Clinical Trial Conditions for RESTORIL

Condition Name

Condition Name for RESTORIL
Intervention	Trials
Anxiety, Post Traumatic	1
High-altitude Sleep Disturbance	1
PTSD	1

Condition MeSH

Condition MeSH for RESTORIL
Intervention	Trials
Dyssomnias	1
Altitude Sickness	1
Stress Disorders, Post-Traumatic	1

Clinical Trial Locations for RESTORIL

Trials by Country

Trials by Country for RESTORIL
Location	Trials
Nepal	1
United States	1

Trials by US State

Trials by US State for RESTORIL
Location	Trials
New York	1

Clinical Trial Progress for RESTORIL

Clinical Trial Phase

Clinical Trial Phase for RESTORIL
Clinical Trial Phase	Trials
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for RESTORIL
Clinical Trial Phase	Trials
Completed	1
Withdrawn	1

Clinical Trial Sponsors for RESTORIL

Sponsor Name

Sponsor Name for RESTORIL
Sponsor	Trials
State University of New York - Upstate Medical University	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for RESTORIL
Sponsor	Trials
Other	2