Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-06FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)
FDA approved a supplemental application for ULTRA SLEEP AID containing doxylamine succinate from Walgreens Company.
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CLINICAL_TRIALS trial_result · 2023-09-18Clinical Trial Update: Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation [Phase 2]
Phase 2 trial assessing safety, tolerability, and efficacy of V117957 for insomnia associated with alcohol cessation has completed with resu…
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CLINICAL_TRIALS trial_result · 2023-09-07Clinical Trial Update: Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia [Phase 3]
Phase 3 clinical trial update evaluating long-term safety and efficacy of zolpidem for chronic insomnia.
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CLINICAL_TRIALS trial_result · 2023-08-16Clinical Trial Update: The CANabidiol Use for RElief of Short Term Insomnia [Phase 2]
Phase 2 clinical trial investigating cannabidiol (CBD) for short-term insomnia shows completion of the study.
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FDA approval · 2023-08-16FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved the original application for a generic doxepin hydrochloride product from Amneal Pharmaceuticals NY LLC. The generic is ind…
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FDA approval · 2023-07-10FDA Approved: RAMELTEON — Original Application (Aurobindo Pharma Limited)
FDA approved an Abbreviated New Drug Application for ramelteon from Aurobindo Pharma Limited, marking the generic version's approval. Ramelt…
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FDA approval · 2023-06-30FDA Approved: TEMAZEPAM — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Temazepam submitted by Alembic Pharmaceuticals Limited.
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FDA approval · 2023-06-28FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)
The FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd.
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FDA approval · 2023-06-27FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Micro Labs Limited)
FDA approved the original abbreviated new drug application for doxepin hydrochloride from Micro Labs Limited. Doxepin hydrochloride is used …
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: Treatment of Insomnia in Migraineurs [Phase 4]
Phase 4 clinical trial update on treating insomnia in patients with migraine completed.
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: PracticeGround: Transforming Training and Delivery of Mental Health EBPs [NA]
A completed clinical trial evaluating PracticeGround training and delivery of mental health evidence-based practices; results were posted in…
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FDA approval · 2023-06-07FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Eszopiclone from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-05-09FDA Approved: ZOLPIDEM TARTRATE — Original Application (Almatica Pharma LLC)
FDA approved zolpidem tartrate from Almatica Pharma LLC under an Original Application for the treatment of insomnia.
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FDA approval · 2023-05-02FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approves a supplemental application for Eszopiclone from Macleods Pharmaceuticals Limited, granting approval for the generic product.
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FDA approval · 2023-04-25FDA Approved: RAMELTEON — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ramelteon by Actavis Pharma, Inc. under an ANDA.
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FDA label_change · 2023-04-20FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)
FDA documents a supplemental labeling application for DAYVIGO (lemborexant) by Eisai Inc., likely to modify the drug’s labeling.
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FDA approval · 2023-04-03FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved Novadoz Pharmaceuticals LLC's original application for doxepin hydrochloride (generic). The approval supports the generic produ…
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FDA approval · 2023-03-24FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)
The FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd.
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CLINICAL_TRIALS withdrawal · 2023-03-24Clinical Trial Update: Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept [Phase 4]
A Phase 4 trial of pimavanserin for insomnia in veterans with PTSD was withdrawn.
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CLINICAL_TRIALS trial_result · 2023-03-23Clinical Trial Update: RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder [NA]
A completed randomized trial evaluating a web-based behavioral sleep intervention for individuals with alcohol use disorder, including insom…
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia [Phase 4]
Phase 4 open-label study assessing transitioning to lemborexant in Japanese adults with insomnia; completed.
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FDA approval · 2023-03-08FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Zolpidem Tartrate (Teva Pharmaceuticals USA, Inc.), the sleep medication previously approved for…
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FDA label_change · 2023-03-08FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for zolpidem tartrate from Sun Pharmaceutical Industries, Inc., under ANDA 204170.
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CLINICAL_TRIALS trial_result · 2023-03-07Clinical Trial Update: Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer [NA]
Clinical trial update on CBT-I for chronic insomnia in lung cancer patients, with results posted after completion.
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CLINICAL_TRIALS trial_result · 2023-03-02Clinical Trial Update: Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes [Phase 4]
Phase 4 clinical trial update evaluating suvorexant for sleep disturbance in adults with chronic insomnia and suboptimally controlled type 2…