Insomnia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2008-07-22Clinical Trial Update: Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs [Phase 2]
Phase 2 efficacy and safety study of adipiplon vs placebo and an active control in adults with primary insomnia was terminated.
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FDA approval · 2008-07-14FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)
The FDA approved a supplemental application for Ultra Sleep Aid (doxylamine succinate) from Walgreens Company.
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FDA approval · 2008-07-14FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
FDA approved Lannett's supplemental application for doxepin hydrochloride, confirming a generic version is approvable. The product will carr…
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma Holdings, Inc.'s original ANDA for Zaleplon, a generic short-acting hypnotic used to treat insomnia.
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s generic Zaleplon via an Original Application, adding a generic option for this sleep medic…
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved Unichem Pharmaceuticals (USA), Inc.'s original ANDA for Zaleplon, a generic version of the sleep medication. This marks the ava…
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FDA approval · 2008-05-29FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approves a supplemental application for zolpidem tartrate (Zolpidem) submitted by ACI Healthcare USA, Inc. The action represents an appr…
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FDA approval · 2008-05-23FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, indicating regulatory action on a generic zolpidem produc…
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FDA approval · 2008-05-13FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
FDA approves a supplemental application for zolpidem tartrate by Sandoz Inc, indicating a modification/added aspect to the approved generic …
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FDA approval · 2008-05-07FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) filed by Cosette Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2008-04-23Clinical Trial Update: The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia [Phase 4]
Phase 4 trial evaluating the effects of modafinil on waking function and sleep in adults with primary insomnia has completed.
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CLINICAL_TRIALS trial_result · 2008-04-03Clinical Trial Update: Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo [Phase 4]
Post-marketing Phase 4 trial comparing residual effects of extended-release zolpidem and eszopiclone versus placebo in adults with insomnia.
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FDA approval · 2008-03-31FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Northstar RxLLC)
FDA approved Northstar RxLLC's Original Application for hydroxyzine hydrochloride, a generic antihistamine product.
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CLINICAL_TRIALS trial_result · 2008-03-18Clinical Trial Update: Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial [NA]
A randomized controlled trial evaluating quetiapine for primary insomnia has completed.
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FDA approval · 2008-02-25FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for RESTORIL (temazepam) filed by SpecGx LLC. The action updates the product labeling under the …
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FDA approval · 2008-02-20FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)
FDA approves a supplemental application for ESTAZOLAM by Dr. Reddy's Laboratories Inc., marking approval of a supplemental submission for th…
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CLINICAL_TRIALS trial_result · 2008-02-15Clinical Trial Update: Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Clinical trial update on nocturnal sleep latency profiling in insomnia; the study status is completed.
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FDA approval · 2008-02-12FDA 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 · 2008-01-30Clinical Trial Update: Efficacy Study of EVT 201 to Treat Insomnia [Phase 2]
Phase 2 efficacy study of EVT 201 for insomnia has completed.
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FDA approval · 2008-01-29FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for LUNESTA (eszopiclone) filed by Waylis Therapeutics LLC.
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FDA approval · 2007-12-20FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for zolpidem tartrate filed by Sanofi-Aventis U.S. LLC.
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CLINICAL_TRIALS trial_result · 2007-12-06Clinical Trial Update: STILDEP: Zolpidem in Depressive and Dysthimic Patients [Phase 4]
Sanofi-sponsored Phase 4 trial evaluating zolpidem in patients with insomnia and depressive disorders (including dysthymia) has completed.
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FDA approval · 2007-12-04FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Estazolam (Actavis Pharma, Inc.). The drug is used for the short-term treatment of insomnia.
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CLINICAL_TRIALS trial_result · 2007-10-12Clinical Trial Update: Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro) [Phase 4]
This Phase 4 study compares Ambien CR to placebo for insomnia associated with anxiety in patients taking escitalopram (Lexapro) and has comp…
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FDA approval · 2007-10-04FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) submitted by Cosette Pharmaceuticals, Inc.