Insomnia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-08-03Clinical Trial Update: Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder [Phase 2]
A Phase 2 clinical trial assessing iron treatment for sleep disorders in children with autism spectrum disorder has completed.
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FDA approval · 2020-07-28FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Contract Pharmacal Corp.)
FDA approved an original application for doxepin hydrochloride, a generic product from Contract Pharmacal Corp., with labeling for major dep…
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FDA approval · 2020-07-24FDA Approved: DOXEPIN — Original Application (Strides Pharma Science Limited)
FDA approved an original application for doxepin hydrochloride (generic doxepin) by Strides Pharma Science Limited, expanding the availabili…
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FDA approval · 2020-07-02FDA Approved: ZOLPIDEM TARTRATE SUBLINGUAL — Supplemental Application (ENDO USA, Inc.)
FDA approved a supplemental application to allow the marketing of zolpidem tartrate sublingual, a sublingual formulation of zolpidem, develo…
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CLINICAL_TRIALS trial_result · 2020-06-04Clinical Trial Update: Insomnia Treatment and Problems (the iTAP Study) [NA]
A completed clinical trial (iTAP Study) investigating insomnia treatment in the context of alcohol-related harm; results posted in 2020.
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FDA approval · 2020-06-04FDA Approved: ZOLPIDEM TARTRATE — Original Application (Breckenridge Pharmaceutical, Inc.)
FDA approves Breckenridge Pharmaceutical's original ANDA for zolpidem tartrate, a generic sleep-aid formulation for insomnia.
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FDA approval · 2020-04-27FDA Approved: ESZOPICLONE — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for eszopiclone, enabling the approval of a generic version manufactured by Bionpharma Inc. for …
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FDA approval · 2020-04-10FDA Approved: RAMELTEON — Original Application (TruPharma, LLC)
FDA approved the original ANDA for ramelteon filed by TruPharma, LLC, establishing a generic ramelteon product.
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CLINICAL_TRIALS trial_result · 2020-04-09Clinical Trial Update: Cognitive Behavioral Therapy With or Without Armodafinil in Treating Cancer Survivors With Insomnia and Fatigue After Chemotherapy [Phase 2]
Phase 2 trial evaluating cognitive behavioral therapy with or without armodafinil for insomnia and fatigue in cancer survivors post-chemothe…
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FDA approval · 2020-04-06FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Aleve PM, adding the diphenhydramine HCl and naproxen sodium combination (Bayer HealthCare LLC) …
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FDA approval · 2020-03-18FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for BELSOMRA (suvorexant) from Merck Sharp & Dohme LLC.
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FDA approval · 2020-03-17FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…
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CLINICAL_TRIALS trial_result · 2020-02-13Clinical Trial Update: Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep [NA]
A terminated clinical trial evaluating Low Field Magnetic Stimulation (LFMS) for primary insomnia; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-02-11Clinical Trial Update: Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) [Phase 3]
Phase 3 SUNRISE 1 study evaluating the efficacy and safety of lemborexant in adults aged 55 and older with insomnia disorder has completed a…
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FDA approval · 2020-02-07FDA Approved: RAMELTEON — Supplemental Application (Dr.Reddys Laboratories Inc)
The FDA entry documents a supplemental application submission for ramelteon from Dr. Reddy's Laboratories as part of an approval action for …
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FDA approval · 2020-02-07FDA Approved: RAMELTEON — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ramelteon (Actavis Pharma, Inc.), resulting in an additional regulatory approval for the product…
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CLINICAL_TRIALS trial_result · 2020-01-31Clinical Trial Update: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia [Phase 2]
Phase 2 randomized trial assessing E2006 for chronic insomnia in adults and elderly, with Bayesian adaptive design; study completed with res…
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FDA approval · 2020-01-29FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for BELSOMRA (suvorexant) submitted by Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2020-01-18Clinical Trial Update: Hyper-Arousal in Chronic Primary Insomnia
A completed clinical trial investigating hyper-arousal in chronic primary insomnia has posted results.
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CLINICAL_TRIALS trial_result · 2020-01-18Clinical Trial Update: A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 [Phase 1]
Phase 1 clinical trial update for E2006 assessing safety, tolerability, PK, and PD in insomnia; completed with results posted.
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FDA approval · 2019-12-26FDA Approved: DIAZEPAM — Original Application (Natco Pharma USA LLC)
FDA approved Natco Pharma USA LLC's original application for a generic diazepam product, enabling its marketing in the United States.
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FDA approval · 2019-12-20FDA Approved: DAYVIGO — Original Application (Eisai Inc.)
FDA approved DAYVIGO (lemborexant) from Eisai as the original application for adults with insomnia, marking the drug's initial regulatory au…
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FDA approval · 2019-12-20FDA Approved: ESZOPICLONE — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved Dr. Reddy's Laboratories Limited's supplemental application for eszopiclone, granting approval of a generic version of the …
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FDA approval · 2019-12-03FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for a generic eszopiclone product from Macleods Pharmaceuticals Limited.
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FDA approval · 2019-11-29FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved Torrent Pharmaceuticals Limited's supplemental application for zolpidem tartrate (generic). The approval allows the generic…