Insomnia
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2022-01-11FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)
The FDA approved a supplemental labeling application for Advil PM, a combination product of diphenhydramine HCl and ibuprofen, by Haleon US …
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FDA approval · 2022-01-10FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
FDA approved a supplemental application for Advil PM, a coated tablet containing ibuprofen and diphenhydramine citrate, with Lil Drug Store …
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FDA approval · 2022-01-07FDA Approved: QUVIVIQ — Original Application (Idorsia Pharmaceuticals Ltd)
FDA approves QUVIVIQ (daridorexant) from Idorsia as an Original Application for treating insomnia in adults.
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FDA approval · 2021-11-12FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc. under an ANDA, reflecting a regulatory action on th…
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FDA approval · 2021-11-03FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ROZEREM (ramelteon) from Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2021-10-29Clinical Trial Update: Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia [Phase 4]
Phase 4 trial update on suvorexant for insomnia, focusing on its efficacy for hot flash-associated insomnia; results posted after completion…
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FDA approval · 2021-10-27FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for HALCION (triazolam) submitted by Pharmacia & Upjohn Company LLC.
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CLINICAL_TRIALS trial_result · 2021-10-07Clinical Trial Update: Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia [Phase 4]
Phase 4 clinical trial investigating the impact of suvorexant on sympathetic nerve activity and baroreflex function in chronic insomnia.
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CLINICAL_TRIALS trial_result · 2021-09-09Clinical Trial Update: CPAP vs ASV for Insomnia [NA]
Clinical trial comparing CPAP and ASV for insomnia and sleep-disordered breathing has completed with results posted.
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FDA approval · 2021-08-04FDA Approved: RAMELTEON — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved Granules Pharmaceuticals' supplemental application for Ramelteon, adding a granule formulation of ramelteon.
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FDA approval · 2021-08-02FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)
The FDA approves a supplemental application for Estazolam, with Novitium Pharma LLC as the sponsor, indicating an expansion/approval under a…
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CLINICAL_TRIALS trial_result · 2021-07-16Clinical Trial Update: Pharmacological Treatment of Insomnia in Palliative Care [Phase 4]
A Phase 4 clinical trial update on pharmacological treatment of insomnia in palliative care has completed, assessing sleep outcomes in this …
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CLINICAL_TRIALS trial_result · 2021-06-22Clinical Trial Update: Study of the Effects of HIRREM-SOP for Insomnia [NA]
A completed clinical trial investigating the effects of HIRREM-SOP for insomnia with results posted in 2021.
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FDA approval · 2021-06-11FDA Approved: TEMAZEPAM — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved a supplemental application for Temazepam filed by Alembic Pharmaceuticals Limited.
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CLINICAL_TRIALS trial_result · 2021-05-26Clinical Trial Update: Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2 [Phase 1, Phase 2]
A Phase 1/Phase 2 trial investigating recovery of damaged cells to address post-COVID-19 sequelae and related conditions. Current status is …
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CLINICAL_TRIALS trial_result · 2021-04-28Clinical Trial Update: Suvorexant in Insomnia Co-morbid With Fibromyalgia [Phase 4]
Phase 4 trial update on suvorexant for insomnia co-morbid with fibromyalgia; study terminated with posted results.
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CLINICAL_TRIALS trial_result · 2021-04-12Clinical Trial Update: A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia [Phase 3]
Phase 3 study evaluating transition from zolpidem to lemborexant for insomnia has completed with posted results.
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CLINICAL_TRIALS withdrawal · 2021-04-09Clinical Trial Update: Ramelteon for Complex Insomnia in Veterans With PTSD [Phase 4]
Phase 4 trial of ramelteon for complex insomnia in veterans with PTSD was withdrawn.
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CLINICAL_TRIALS trial_result · 2021-03-30Clinical Trial Update: Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
A completed clinical trial evaluating how hyperarousal affects performance on simple and complex cognitive tasks in individuals with insomni…
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CLINICAL_TRIALS trial_result · 2021-03-29Clinical Trial Update: Ramelteon for Treatment of Insomnia in Cirrhosis [Phase 4]
Phase 4 clinical trial of ramelteon for insomnia in patients with cirrhosis has completed with results posted.
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FDA approval · 2021-03-25FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for BELSOMRA (suvorexant) from Merck Sharp & Dohme LLC, updating the product labeling.
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CLINICAL_TRIALS trial_result · 2021-03-23Clinical Trial Update: Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors [NA]
Update on a completed clinical trial evaluating yoga, survivorship health education, and cognitive behavioral therapy to reduce insomnia in …
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FDA approval · 2021-03-09FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Leading Pharma, LLC)
FDA approved the original application for doxepin hydrochloride (generic) from Leading Pharma, LLC, for use in treating depressive disorders…
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CLINICAL_TRIALS trial_result · 2021-02-24Clinical Trial Update: Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia [Phase 4]
A Phase 4 trial comparing 5 mg sublingual zolpidem to 10 mg oral zolpidem for induction and maintenance of sleep in adults with primary inso…
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CLINICAL_TRIALS withdrawal · 2021-02-21Clinical Trial Update: Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia [Phase 4]
A Phase 4 trial of suvorexant (Belsomra) for bipolar depression with insomnia has been withdrawn.