List of investigational insomnia drugs

This is a list of investigational insomnia drugs, or drugs that are currently under development for clinical use for the treatment of insomnia but are not yet approved. They may also be referred to as investigational hypnotics.

Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses. The format of list items is "Name (Synonyms) – Mechanism of Action [Reference]".

This list was last comprehensively updated in September 2025. It is likely to become outdated with time.

Under development

Preregistration

  • Tasimelteon (Hetlioz; BMS-214778; VEC-162) – melatonin MT1 and MT2 receptor agonist[1]

Phase 3

  • Brexpiprazole (Rexulti; Lu-AF41156; OPC-34712; OPDC-34712) – atypical antipsychotic (non-selective monoamine receptor modulator)[2]
  • Cannabidiol soft-gel (CBD soft-gel; CBD-TPM) — cannabinoid and various actions[3][4]
  • Diphenhydramine/lorazepam/zolpidem (SM-1; SM1) – combination of diphenhydramine (antihistamine and anticholinergic), lorazepam (benzodiazepine and GABAA receptor positive allosteric modulator), and zolpidem (nonbenzodiazepine/Z-drug and GABAA receptor positive allosteric modulator)[5]
  • Zuranolone (BIIB-125; S-812217; SAGE-217; SGE-797; Zurzuvae) – GABAA receptor positive allosteric modulator and neurosteroid[6]

Phase 2

  • Dexmedetomidine buccal (RE-03) — α2-adrenergic receptor agonist[7]
  • Lumateperone (Caplyta; ITI-007; ITI-722) – atypical antipsychotic (non-selective monoamine receptor modulator)[8]
  • Pimavanserin (Nuplazid; ACP-103; BVF-048) – serotonin 5-HT2A receptor antagonist[9]
  • Piromelatine (Neu-P11) – melatonin MT1 and MT2 receptor agonist, serotonin 5-HT1A and 5-HT1D receptor agonist, and serotonin 5-HT2B receptor antagonist[10]
  • Seltorexant (JNJ-42847922; JNJ-7922; MIN-202) – orexin OX2 receptor antagonist[11]
  • Sunobinop (IMB-115; IT-1315; RSC117957; S-117957; V-117957) – nociceptin receptor agonist[12]
  • Trazodone extended-release (AF-1161; DDS-04A; Oleptro; Triticum AC; Trittico) – serotonin 5-HT1A receptor partial agonist, serotonin 5-HT2A and 5-HT2C receptor antagonist, α1- and α2-adrenergic receptor antagonist, weak serotonin reuptake inhibitor, and other actions[13]

Phase 1/2

  • SVT-4A1011 – microbiome modulator and live microbial therapeutic[14]

Phase 1

  • Ramelteon controlled-release – melatonin MT1 and MT2 receptor agonist[15]

Preclinical

  • APSTZD (APS-TZD) – undefined mechanism of action[16]
  • HS-10506 – orexin OX2 receptor antagonist[17]
  • TPT-0601 – fatty acid amide hydrolase (FAAH) inhibitor[18][19]
  • YZG-331 – adenosine receptor agonist[20][21]

Research

  • Trazodone (TrazoFlex-24; TrazoFlex-CR; TrazoFlex) – serotonin 5-HT1A receptor partial agonist, serotonin 5-HT2A and 5-HT2C receptor antagonist, α1- and α2-adrenergic receptor antagonist, weak serotonin reuptake inhibitor, and other actions[22]

Phase unknown

  • Midazolam sublingual film – GABAA receptor positive allosteric modulator and benzodiazepine[23]
  • OP-010 (OP010) – undefined mechanism of action[24]
  • Zolpidem extended-release – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[25]

Not under development

Suspended

No development reported

  • Filorexant (MK-6096) – orexin OX1 and OX2 receptor antagonist[28]
  • HEC-83518 – orexin receptor antagonist[29][30]
  • IN-AQUL-001 – undefined mechanism of action[31][32]
  • JNJ-48816274 – orexin OX2 receptor antagonist[33]
  • Lirequinil (RO-413696) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/benzoquinolizinone [34]
  • Lorediplon (GF-015535-00) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/pyrazolopyrimidine[35]
  • MK-1064 – orexin OX2 receptor antagonist[36]
  • Research programme: psychophysiological insomnia therapeutics - Neurim Pharmaceuticals – melatonin and serotonin receptor agonists[37]
  • Zolpidem topical gel (TR-396) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[38]

Discontinued

  • ACT-462206 – orexin OX1 and OX2 receptor antagonist[39]
  • Adipiplon (NG-273) – GABAA receptor positive allosteric modulator[40]
  • ADX-10061 (NNC 01-0687; CEE-03-310; NNC-687) – dopamine D1 receptor antagonist[41][42][43]
  • Almorexant (ACT-078573) – orexin OX1 and OX2 receptor antagonist[44]
  • ANPH-101 – undefined mechanism of action[45]
  • Atagabalin (PD-0200390) – gabapentinoid (α2δ voltage-gated calcium channel ligand)[46]
  • Eplivanserin (Ciltyri; Sliwens; SR–46349; SR–46349B; SR–46615A) – serotonin 5-HT2A receptor antagonist[47]
  • Esmirtazapine (ORG-50081; SCH-900265; (S)-mirtazapine) – histamine H1 receptor antagonist, serotonin 5-HT2 receptor antagonist, and α2-adrenergic receptor antagonist[48]
  • Gaboxadol (LU-02030; LU-2-030; MK-0928; OV-101; THIP) – GABAA receptor agonist[49]
  • GT-2203 – histamine H3 receptor agonist[50]
  • Indiplon (NBI-34060) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/pyrazolopyrimidine[51][52][53][54]
  • LY-2624803 (HY-10275) – histamine H1 receptor inverse agonist and serotonin 5-HT2A receptor antagonist[55]
  • Nabilone (Cesamet) – cannabinoid CB1 and CB2 receptor agonist[56]
  • NBI-75043 – antihistamine (histamine H1 receptor antagonist)[57]
  • Nelotanserin (APD-125; RVT-102) – serotonin 5-HT2A receptor antagonist[58]
  • NGD-962 (NGD 96-2) – GABAA receptor modulator[59]
  • Paliperidone (Invega; JNS-007ER; RO-76477; 9-hydroxyrisperidone) – atypical antipsychotic (non-selective monoamine receptor modulator)[60]
  • PD-0299685 (PF-299685) – gabapentinoid (α2δ voltage-gated calcium channel ligand)[61]
  • Pruvanserin (EMD-281014; LY-2422347; LSN-2411347) – serotonin 5-HT2A receptor antagonist[62]
  • Remimazolam (HR-7056; Byfavo) – GABAA receptor positive allosteric modulator and benzodiazepine[63]
  • Seganserin (R-56413) – serotonin 5-HT2A and 5-HT2C receptor antagonist[64]
  • Suvecaltamide (CX-8998; JZP-385; MK-8998) – T-type calcium channel inhibitor[65]
  • Tasipimidine (ODM-105) – α2A-adrenergic receptor agonist[66]
  • Tesamorelin (Egrifta; MDVTM; TH-9507; ThGRF 1-44) – growth hormone-releasing hormone (GHRH) receptor agonist[67]
  • Tiagabine (A-70569; CEP-6671; Gabitril; NO-050328; NO-328) – GABA transporter 1 (GAT-1) blocker and GABA reuptake inhibitor[68]
  • Triazolam intranasal (Hypnostat; TGAR01H) – GABAA receptor positive allosteric modulator and benzodiazepine[69]
  • Volinanserin (M-100907; MDL-100907) – serotonin 5-HT2A receptor antagonist[70]

Formal development never or not yet started

Clinically used drugs

Approved drugs

GABAA receptor positive allosteric modulators

Benzodiazepines

Nonbenzodiazepines/Z-drugs

  • Eszopiclone (Esopiclone; Estorra; Lunesta; Lunivia; S-Zopiclone; SEP-0227018; SEP-190; SEP-225441) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[81]
  • Zaleplon (Sonata; Zerene; CL–284846; L–846; LJC–10846) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[82]
  • Zolpidem extended-release (Ambien CR; FK-199B; Stilnox; Zolpidem XR) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[83]
  • Zolpidem oral spray (Zolpimist) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[84]
  • Zolpidem sublingual (Edluar; Sublinox; OX-22) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[85]

Orexin receptor antagonists

  • Daridorexant (Quviviq; ACT-541468; nemorexant) – orexin OX1 and OX2 receptor antagonist[86]
  • Fazamorexant (Mengping; HY-901139; YZJ-1139) – orexin OX1 and OX2 receptor antagonist[87]
  • Lemborexant (Dayvigo; E-2006) – orexin OX1 and OX2 receptor antagonist[88]
  • Suvorexant (Belsomra; MK-4305) – orexin OX1 and OX2 receptor antagonist[89]
  • Vornorexant (Vorzzz; ORN-0829; TS-142) – orexin OX1 and OX2 receptor antagonist[90]

Melatonin receptor agonists

  • Melatonin controlled-release (Circadin; Orlogin; PedPRM; Slenyto; KI-1001) – melatonin MT1 and MT2 receptor agonist[91]
  • Ramelteon (Rozerem; TAK-375) – melatonin MT1 and MT2 receptor agonist[92]

Other drugs

Withdrawn drugs

GABAA receptor positive allosteric modulators

  • Zolpidem sublingual (Intermezzo) – GABAA receptor positive allosteric modulator and nonbenzodiazepine/Z-drug[97]

Discontinued drugs

GABAA receptor positive allosteric modulators

Other drugs

  • Fenadiazole (phénadiazole; Hypnazol, Eudormil, Viodor) – unknown mechanism of action

Off-label drugs

See also

References

  1. ↑ "Tasimelteon - Vanda Pharmaceuticals - AdisInsight".
  2. ↑ "Brexpiprazole - Lundbeck/Otsuka - AdisInsight".
  3. ↑ "Cannabidiol soft-gel - Avecho Biotechnology - AdisInsight".
  4. ↑ Stevens, Ben (13 July 2026). "World's Largest CBD Insomnia Trial Could Hand Avecho an Australian Monopoly". Business of Cannabis. Retrieved 8 August 2026.
  5. ↑ "Diphenhydramine/Lorazepam/Zolpidem - Eusol Biotech - AdisInsight".
  6. ↑ "Zuranolone - Biogen/SAGE Therapeutics - AdisInsight".
  7. ↑ "Dexmedetomidine - Reconnect Labs - AdisInsight".
  8. ↑ "Lumateperone - Intra-Cellular Therapies - AdisInsight".
  9. ↑ "Pimavanserin - ACADIA Pharmaceuticals - AdisInsight".
  10. ↑ "Piromelatine - Neurim Pharmaceuticals - AdisInsight".
  11. ↑ "Seltorexant - Janssen Research & Development/Minerva Neurosciences - AdisInsight".
  12. ↑ "Sunobinop - Imbrium Therapeutics/Shionogi - AdisInsight".
  13. ↑ "Trazodone - Angelini Group/Labopharm - AdisInsight".
  14. ↑ "SVT 4A1011 - AdisInsight".
  15. ↑ "Ramelteon controlled-release - Overseas Pharmaceuticals - AdisInsight".
  16. ↑ "APSTZD - Apsen Farmaceutica - AdisInsight".
  17. ↑ "HS 10506 - AdisInsight".
  18. ↑ "TPT 0601 - AdisInsight".
  19. ↑
  20. ↑ "Delving into the Latest Updates on YZG-331 with Synapse". Synapse. 8 May 2025. Retrieved 6 October 2025.
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  23. ↑ "Midazolam sublingual film - Aoxing Pharmaceutical Company - AdisInsight".
  24. ↑ "OP 010 - AdisInsight".
  25. ↑ "Zolpidem extended release - Beijing CoSci Med Tech - AdisInsight".
  26. ↑ "Osemozotan". AdisInsight. 11 December 2025. Retrieved 7 August 2026.
  27. ↑ "SEC Filing". MediciNova. 17 September 2009. Retrieved 7 August 2026. For example, in October 2007, MediciNova announced that its Phase II clinical trial of MN-305 for the treatment of insomnia failed to achieve statistical significance in its primary endpoint; as a result, MediciNova terminated development of MN-305 for the treatment of insomnia. [...] Phase II clinical trial in insomnia completed in Q4, 2007†† [...] †† In the Phase II clinical trial conducted on MN-305 in insomnia, the predefined statistical endpoint of the clinical trial was not achieved; therefore, MediciNova terminated any further development of MN-305 for the treatment of insomnia. [...]
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  29. ↑ "HEC 83518 - AdisInsight".
  30. ↑
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  38. ↑ "Zolpidem topical gel - Tritech Biopharmaceuticals - AdisInsight".
  39. ↑ "ACT 462206 - AdisInsight".
  40. ↑ "Adipiplon - AdisInsight".
  41. ↑ "ADX 10061 - AdisInsight".
  42. ↑ Eder DN (February 2002). "CEE-03-310 CeNeS pharmaceuticals". Curr Opin Investig Drugs. 3 (2): 284–288. PMID 12020061. CEE-03-310 is a selective dopamine D1-like receptor antagonist with no appreciable binding affinity for other receptors. Although originally developed by Novo Nordisk A/S as NNC-687 for the treatment of schizophrenia, the company changed its therapeutic focus in the mid-1990s and the full rights to CEE-03-310 and several related compounds were subsequently granted to CeNeS Pharmaceuticals in 1999. CeNeS is currently investigating the drug's potential in the treatment of insomnia and alcohol dependency [340965], [382293], [401496],[416026]. A phase II, double-blind, placebo-controlled trial of CEE-03-310 demonstrated a dose-dependent enhancement of NREM sleep at the beginning of the night without any effects on the quantity of REM sleep [410739].
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  45. ↑ "ANPH 101 - AdisInsight".
  46. ↑ "Atagabalin - AdisInsight".
  47. ↑ "Eplivanserin - AdisInsight".
  48. ↑ "Esmirtazapine - AdisInsight".
  49. ↑ "Gaboxadol - Lundbeck A/S - AdisInsight".
  50. ↑ "GT 2203 - AdisInsight".
  51. ↑ "Indiplon - AdisInsight".
  52. ↑ "Delving into the Latest Updates on Indiplon with Synapse".
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  57. ↑ "NBI 75043 - AdisInsight".
  58. ↑ "Nelotanserin - Sio Gene Therapies - AdisInsight".
  59. ↑ "NGD 962 - AdisInsight".
  60. ↑ "Paliperidone - Johnson & Johnson - AdisInsight".
  61. ↑ "PD 0299685 - AdisInsight".
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  63. ↑ "Remimazolam tosylate - Jiangsu Hengrui Medicine - AdisInsight".
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  66. ↑ "Tasipimidine - Orion - AdisInsight".
  67. ↑ "Tesamorelin - Theratechnologies - AdisInsight".
  68. ↑ "Tiagabine". AdisInsight. 24 October 2021. Retrieved 17 January 2026.
  69. ↑ "Triazolam intranasal - Fabre Kramer - AdisInsight".
  70. ↑ "Volinanserin - AdisInsight".
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  82. ↑ "Zaleplon - Pfizer - AdisInsight".
  83. ↑ "Zolpidem extended release - Cosette Pharmaceuticals/Sanofi-aventis - AdisInsight".
  84. ↑ "Zolpidem oral spray - Amherst Pharmaceuticals - AdisInsight".
  85. ↑ "Zolpidem sublingual - Orexo - AdisInsight".
  86. ↑ "Daridorexant - Idorsia Pharmaceuticals - AdisInsight".
  87. ↑ "YZJ 1139 - AdisInsight".
  88. ↑ "Lemborexant - Eisai - AdisInsight".
  89. ↑ "Suvorexant - Merck & Co - AdisInsight".
  90. ↑ "Vornorexant - Taisho Pharmaceutical - AdisInsight".
  91. ↑ "Melatonin controlled-release - Neurim Pharmaceuticals - AdisInsight".
  92. ↑ "Ramelteon - Takeda - AdisInsight".
  93. ↑ "Doxepin low dose - Somaxon Pharmaceuticals - AdisInsight".
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  105. ↑ Broese M, Riemann D, Hein L, Nissen C (September 2012). "α-Adrenergic receptor function, arousal and sleep: mechanisms and therapeutic implications". Pharmacopsychiatry. 45 (6): 209–216. doi:10.1055/s-0031-1299728. PMID 22290201. Tizanidine is a centrally acting α2 -receptor agonist, structurally related to clonidine. [...] In a study by Tanaka et al. [ 75 ] tizanidine was used in children with spastic quadriplegia to treat refractory sleep disturbances. Tizanidine treatment improved sleep induction and/or maintenance in 61.9 % of the children.
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