Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-02-21FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
FDA approved a supplemental application for Advil PM (diphenhydramine citrate and ibuprofen) tablets, coated, expanding its regulatory autho…
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FDA approval · 2023-02-17FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic doxepin hydrochloride for oral use under an Original Application (ANDA).
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CLINICAL_TRIALS trial_result · 2023-02-16Clinical Trial Update: CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes [NA]
Clinical trial update on CBT-I for psychosis reports guidelines, preliminary efficacy, and functional outcomes for insomnia and psychosis, w…
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CLINICAL_TRIALS trial_result · 2023-02-15Clinical Trial Update: Suvorexant and Trauma Related Insomnia [Phase 4]
Phase 4 trial update on suvorexant for trauma-related insomnia completed; results posted in 2023.
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CLINICAL_TRIALS research · 2023-02-09Clinical Trial Update: Insomnia Self-Management in Heart Failure [NA]
Clinical trial update on insomnia self-management in heart failure; study completed with results posted.
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FDA approval · 2023-02-09FDA Approved: RAMELTEON — Original Application (Micro Labs Limited)
FDA approved an Abbreviated New Drug Application for ramelteon from Micro Labs Limited, establishing a generic version of the insomnia drug …
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CLINICAL_TRIALS trial_result · 2023-02-08Clinical Trial Update: Improving Sleep Using Mentored Behavioral and Environmental Restructuring [NA]
A completed clinical trial evaluating mentored behavioral and environmental restructuring for improving sleep in individuals with insomnia; …
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FDA approval · 2023-01-25FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)
FDA approves a supplemental application for DAYVIGO (lemorexant) from Eisai Inc., incorporating labeling changes.
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FDA approval · 2023-01-17FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)
FDA approved a supplemental application for Estazolam from Novitium Pharma LLC.
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FDA approval · 2023-01-17FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)
FDA approved a supplemental application for Estazolam from Dr. Reddy's Laboratories under ANDA074921, resulting in updated labeling and manu…
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FDA approval · 2023-01-17FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Estazolam from Actavis Pharma, Inc., updating the regulatory status of this benzodiazepine produ…
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FDA approval · 2023-01-17FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for flurazepam hydrochloride, with Chartwell RX, LLC listed as the manufacturer. Flurazepam hydrochl…
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FDA approval · 2023-01-17FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Flurazepam hydrochloride from Chartwell RX, LLC, indicating continued approval of this generic d…
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FDA approval · 2023-01-13FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for HALCION (triazolam) from Pharmacia & Upjohn Company LLC. The action updates the existing approva…
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FDA approval · 2023-01-13FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for RESTORIL (temazepam) submitted by SpecGx LLC.
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FDA approval · 2023-01-11FDA Approved: TEMAZEPAM — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Temazepam submitted by Amneal Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2023-01-06Clinical Trial Update: The Menopause After Cancer Study [Phase 2]
Phase 2 clinical trial update for the Menopause After Cancer Study completed, investigating menopause-related symptoms in cancer patients.
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CLINICAL_TRIALS trial_result · 2022-12-29Clinical Trial Update: Insomnia Prevalence and Treatment Impact on Systemic Hypertension [Phase 4]
Phase 4 clinical trial investigating insomnia prevalence and its impact on systemic hypertension has been terminated.
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FDA approval · 2022-12-28FDA Approved: TRIAZOLAM — Original Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved TRIAZOLAM under an Original Application, authorizing the marketing of a generic triazolam product by Zydus Pharmaceuticals …
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FDA approval · 2022-11-25FDA Approved: RAMELTEON — Original Application (Xiromed, LLC)
FDA approved Xiromed, LLC's ramelteon under an Original Application, providing a generic option for adults with insomnia characterized by di…
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FDA approval · 2022-11-21FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for zolpidem tartrate (Sandoz Inc) under ANDA 090107. The snippet does not specify the exact change,…
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FDA approval · 2022-11-21FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)
The FDA approved Breckenridge Pharmaceutical, Inc.'s supplemental application for zolpidem tartrate.
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FDA label_change · 2022-11-17FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approved a supplemental application for zolpidem tartrate submitted by ACI Healthcare USA, Inc., resulting in updated labeling for the p…
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CLINICAL_TRIALS trial_result · 2022-11-15Clinical Trial Update: Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome) [Phase 4]
Phase 4 trial update for Xuefu-Zhuyu Capsule investigating Qi stagnation and blood stasis syndrome; status is unknown with conditions includ…
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CLINICAL_TRIALS trial_result · 2022-11-14Clinical Trial Update: Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia [Phase 3]
Phase 3 clinical trial update investigating intranasal dexmedetomidine and zolpidem for treatment of primary insomnia.