Insomnia

• FDA approval · 2026-04-15
  FDA Approved: RAMELTEON — Supplemental Application (Micro Labs Limited)

  The FDA approved a supplemental application for ramelteon from Micro Labs Limited, under the ANDA supplemental process.

• EMA approval · 2026-03-12
  EMA Authorised: Quviviq (daridorexant hydrochloride) — Idorsia Pharmaceuticals Deutschland GmbH

  EU has authorised Quviviq (daridorexant hydrochloride) by Idorsia for sleep initiation and maintenance disorders. This approval provides a n…

• EMA approval · 2025-11-11
  EMA Authorised: Slenyto (melatonin) — RAD Neurim Pharmaceuticals EEC SARL

  The EMA authorised Slenyto (melatonin) for sleep initiation and maintenance disorders and sleep disturbances associated with autism spectrum…

• FDA approval · 2025-08-22
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approved a Diphenhydramine hydrochloride product from Micro Labs Limited under Original Application (ANDA 219845). This approval covers …

• EMA approval · 2025-07-07
  EMA Authorised: Circadin (melatonin) — RAD Neurim Pharmaceuticals EEC SARL

  The EMA authorised Circadin (melatonin) by RAD Neurim Pharmaceuticals EEC SARL for Sleep Initiation and Maintenance Disorders, with decision…

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• FDA approval · 2025-03-10
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for BELSOMRA (suvorexant) by Merck Sharp & Dohme LLC.

• FDA approval · 2025-02-19
  FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)

  This FDA page documents Eisai Inc.'s supplemental application for Dayvigo (lemborexant), seeking to modify or expand its labeling for the tr…

• FDA approval · 2025-01-14
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for zolpidem tartrate. This represents a supplemental approval for a…

• FDA approval · 2024-09-30
  FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)

  The FDA approved a supplemental application for QUVIVIQ (daridorexant) submitted by Idorsia Pharmaceuticals Ltd.

• FDA approval · 2024-08-19
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for temazepam submitted by Ascend Laboratories, LLC.

• FDA approval · 2024-07-26
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for Temazepam (generic) under ANDA071456, authorizing the marketed Temazepam …

• FDA approval · 2024-07-25
  FDA Approved: DOXEPIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for doxepin from Aurobindo Pharma Limited, granting approval for a generic doxepin product.

• FDA approval · 2024-07-01
  FDA Approved: DOXEPIN — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for doxepin (Doxepin), a generic antidepressant/tricyclic used for depression, an…

• FDA approval · 2024-04-04
  FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)

  FDA approved a supplemental application for Ultra Sleep Aid (doxylamine succinate) from Walgreens Company, updating its labeling for use as …

• FDA approval · 2024-03-20
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a generic diphenhydramine hydrochloride product through an Original Application (ANDA 218448) by Sagent Pharmaceuticals.

• FDA approval · 2024-03-14
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Temazepam (generic) from Ascend Laboratories, LLC.

• FDA approval · 2024-02-20
  FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)

  FDA approved Walgreens' supplemental application for Ultra Sleep Aid (doxylamine succinate) under the ANDA framework, indicating a supplemen…

• FDA approval · 2024-01-16
  FDA Approved: DOXEPIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for the generic doxepin from Actavis Pharma, Inc., adding regulatory authorization for this prod…

• FDA approval · 2024-01-04
  FDA Approved: ESZOPICLONE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approves Camber Pharmaceuticals' original ANDA for eszopiclone, a generic sleep medication used to treat insomnia.

• FDA approval · 2023-11-18
  FDA Approved: TEMAZEPAM — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for temazepam submitted by Actavis Pharma, Inc., under the ANDA process.

• FDA approval · 2023-11-17
  FDA Approved: TEMAZEPAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Temazepam from Amneal Pharmaceuticals LLC under the ANDA program.

• FDA approval · 2023-10-30
  FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)

  FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd, updating the product's labeling.

• FDA approval · 2023-10-06
  FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)

  FDA approved a supplemental application for ULTRA SLEEP AID containing doxylamine succinate from Walgreens Company.

• FDA approval · 2023-08-16
  FDA 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…

• FDA approval · 2023-07-10
  FDA 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…