Insomnia
📧 Sign up to get email alerts when something new happens for Insomnia.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS research · 2009-05-05Clinical Trial Update: Quetiapine for the Treatment of Insomnia in Alzheimer's Disease [NA]
Clinical trial update evaluating quetiapine for insomnia in Alzheimer's disease; the current study status is unknown.
-
CLINICAL_TRIALS research · 2009-04-28Clinical Trial Update: Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia [Phase 2]
This update describes a Phase 2 trial evaluating whether activities and exercise improve sleep in elderly individuals with dementia. The stu…
-
FDA approval · 2009-04-23FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC.
-
CLINICAL_TRIALS trial_result · 2009-04-07Clinical Trial Update: Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia [Phase 3]
A Phase 3 trial evaluated zolpidem (Ambien) for ADHD-associated insomnia in children aged 6 to 17, assessing efficacy, safety, and tolerabil…
-
FDA approval · 2009-04-06FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2009-04-06Clinical Trial Update: Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG) [Phase 3]
Phase 3 results evaluating the efficacy and safety of Zolpidem-MR given long-term as needed for insomnia, sponsored by Sanofi.
-
FDA approval · 2009-03-31FDA Approved: TEMAZEPAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Temazepam from Actavis Pharma, Inc., indicating approval of an additional aspect of the product'…
-
CLINICAL_TRIALS trial_result · 2009-03-25Clinical Trial Update: A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia [Phase 2]
A Phase 2 trial comparing prolonged-release melatonin with placebo in adults with type 2 diabetes and insomnia; results have been completed …
-
FDA approval · 2009-03-13FDA Approved: EDLUAR — Original Application (Viatris Specialty LLC)
The FDA approved EDLUAR (zolpidem tartrate) through Viatris Specialty LLC's original NDA (NDA021997) for the treatment of insomnia.
-
FDA approval · 2009-03-10FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, signaling an approval related to a generic product under an A…
-
CLINICAL_TRIALS withdrawal · 2009-02-12Clinical Trial Update: A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia [Phase 2]
Pfizer's Phase 2 dose-ranging trial of PD 0200390 in elderly subjects with primary insomnia has been withdrawn.
-
FDA approval · 2009-01-23FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for zolpidem tartrate from NorthStar Rx LLC under ANDA078413, enabling its continued marketing a…
-
CLINICAL_TRIALS trial_result · 2009-01-16Clinical Trial Update: Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients [Phase 1]
The document reports the completion of a Phase 1 clinical trial evaluating cognitive behavioral therapy for insomnia in patients with chroni…
-
FDA approval · 2009-01-08FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)
The FDA approved a supplemental application for estazolam by Dr. Reddy's Laboratories Inc. (ANDA074921).
-
CLINICAL_TRIALS trial_result · 2009-01-06Clinical Trial Update: Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly [Phase 4]
Phase 4 clinical trial update on cognitive-behavioural therapy with hypnotic treatment for chronic primary insomnia in older adults; the stu…
-
FDA approval · 2008-11-06FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for zolpidem tartrate by Teva Pharmaceuticals USA, Inc., indicating an approved change to the produc…
-
FDA approval · 2008-10-20FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc., resulting in a labeli…
-
CLINICAL_TRIALS trial_result · 2008-10-17Clinical Trial Update: A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys [Phase 2]
This document reports the completion of a Phase 2 pilot trial evaluating whether microcurrent therapy affects three sleep survey measures in…
-
FDA approval · 2008-10-14FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ESTAZOLAM from Actavis Pharma, Inc., authorizing the ESTAZOLAM product under the approved drug f…
-
FDA approval · 2008-09-10FDA Approved: LORAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for lorazepam submitted by Teva Pharmaceuticals USA, Inc., under the existing approval of the dr…
-
FDA approval · 2008-09-09FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)
FDA approved a supplemental ANDA for ESTAZOLAM by Novitium Pharma LLC. Estazolam is a prescription sleep aid used to treat insomnia.
-
FDA approval · 2008-09-03FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approved a supplemental application for Zolpidem tartrate by ACI Healthcare USA, Inc.
-
FDA approval · 2008-08-20FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ESTAZOLAM from Actavis Pharma, Inc., related to the generic insomnia medication estazolam.
-
FDA label_change · 2008-08-05FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Hydroxyzine Hydrochloride (Teva Pharmaceuticals USA, Inc.), updating the labeling.
-
CLINICAL_TRIALS trial_result · 2008-07-28Clinical Trial Update: Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro [Phase 4]
Phase 4 trial evaluating Ambien CR (zolpidem tartrate extended-release) for insomnia associated with depression when used with Lexapro (esci…