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Condition (MeSH)

Sleep Initiation and Maintenance Disorders

ClinicalTrials.gov lists 2,655 trials for Sleep Initiation and Maintenance Disorders or a narrower condition beneath it. VA Office of Research and Development has the most among industry and government lead sponsors, with 49.

MeSH D007319 Nervous System Diseases C10 F03
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Phase 1 Phase 1 82 Phase 1/2 Phase 1/2 17 Phase 2 Phase 2 133 Phase 2/3 Phase 2/3 18 Phase 3 Phase 3 151 Phase 4 Phase 4 137 Not applicable Not applicable 1,796 Observational Observational 320 Phase 1 Phase 1 82 Phase 1/2 Phase 1/2 17 Phase 2 Phase 2 133 Phase 2/3 Phase 2/3 18 Phase 3 Phase 3 151 Phase 4 Phase 4 137 Not applicable Not applicable 1,796 Observational Observational 320

Trials per phase (log scale)

1 more section with rows

2,638 of the 2,655 trials are tagged with Sleep Initiation and Maintenance Disorders itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Sleep Initiation and Maintenance Disorders trials start? (32)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 5 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 311

1995: 1 trials (Phase 2 1) 1996: 1 trials (Phase 2 1) 1997: 2 trials (Observational 1, Not applicable 1) 1998: 3 trials (Phase 4 1, Phase 3 2) 1999: 2 trials (Not applicable 1, Phase 2/3 1) 2000: 3 trials (Not applicable 2, Phase 2 1) 2001: 5 trials (Phase 4 1, Phase 3 1, Phase 2 2, Phase 1 1) 2002: 9 trials (Not applicable 2, Phase 4 1, Phase 3 4, Phase 2 1, Phase 1/2 1) 2003: 14 trials (Not applicable 4, Phase 4 1, Phase 3 7, Phase 2 2) 2004: 30 trials (Observational 1, Not applicable 4, Phase 4 2, Phase 3 16, Phase 2 4, Phase 1 3) 2005: 45 trials (Observational 4, Not applicable 8, Phase 4 8, Phase 3 14, Phase 2/3 1, Phase 2 8, Phase 1/2 1, Phase 1 1) 2006: 65 trials (Observational 3, Not applicable 15, Phase 4 15, Phase 3 16, Phase 2/3 1, Phase 2 12, Phase 1/2 1, Phase 1 2) 2007: 54 trials (Observational 5, Not applicable 5, Phase 4 12, Phase 3 14, Phase 2/3 3, Phase 2 8, Phase 1/2 1, Phase 1 6) 2008: 64 trials (Observational 6, Not applicable 27, Phase 4 4, Phase 3 10, Phase 2/3 2, Phase 2 9, Phase 1/2 1, Phase 1 5) 2009: 48 trials (Observational 5, Not applicable 24, Phase 4 3, Phase 3 5, Phase 2/3 1, Phase 2 5, Phase 1/2 1, Phase 1 4) 2010: 45 trials (Observational 3, Not applicable 20, Phase 4 3, Phase 3 7, Phase 2/3 1, Phase 2 1, Phase 1 10) 2011: 43 trials (Observational 6, Not applicable 20, Phase 4 1, Phase 3 6, Phase 2 4, Phase 1 6) 2012: 43 trials (Observational 4, Not applicable 22, Phase 4 3, Phase 3 7, Phase 2/3 1, Phase 2 3, Phase 1 3) 2013: 49 trials (Observational 4, Not applicable 33, Phase 4 3, Phase 3 3, Phase 2/3 2, Phase 2 3, Phase 1 1) 2014: 50 trials (Observational 6, Not applicable 37, Phase 4 2, Phase 3 1, Phase 2 1, Phase 1 3) 2015: 59 trials (Observational 8, Not applicable 39, Phase 4 3, Phase 3 1, Phase 2 5, Phase 1/2 1, Phase 1 2) 2016: 81 trials (Observational 3, Not applicable 62, Phase 4 5, Phase 3 6, Phase 2 3, Phase 1/2 2) 2017: 92 trials (Observational 11, Not applicable 62, Phase 4 9, Phase 3 2, Phase 2 3, Phase 1/2 1, Phase 1 4) 2018: 111 trials (Observational 14, Not applicable 85, Phase 4 3, Phase 3 4, Phase 2/3 1, Phase 2 3, Phase 1 1) 2019: 108 trials (Observational 11, Not applicable 78, Phase 4 9, Phase 3 3, Phase 2 5, Phase 1 2) 2020: 131 trials (Observational 19, Not applicable 100, Phase 4 3, Phase 3 1, Phase 2 5, Phase 1 3) 2021: 172 trials (Observational 22, Not applicable 135, Phase 4 5, Phase 3 2, Phase 2/3 1, Phase 2 3, Phase 1/2 1, Phase 1 3) 2022: 199 trials (Observational 26, Not applicable 155, Phase 4 5, Phase 3 1, Phase 2/3 1, Phase 2 7, Phase 1/2 1, Phase 1 3) 2023: 231 trials (Observational 24, Not applicable 178, Phase 4 10, Phase 3 3, Phase 2/3 1, Phase 2 9, Phase 1/2 2, Phase 1 4) 2024: 279 trials (Observational 30, Not applicable 225, Phase 4 4, Phase 3 6, Phase 2 8, Phase 1/2 1, Phase 1 5) 2025: 311 trials (Observational 57, Not applicable 225, Phase 4 9, Phase 3 5, Phase 2 9, Phase 1 6)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 298
2025 311
2024 279
2023 231
2022 199
2021 172
2020 131
2019 108
2018 111
2017 92

Showing 10 of 32 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 350 trials starting in 2026 and about 320 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 34 months from start to primary completion across 323 trials still running at the 2026-10-09 snapshot; registered median of 14 months across 1,602 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Sleep Initiation and Maintenance Disorders trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 82
Phase 1/2 17
Phase 2 133
Phase 2/3 18
Phase 3 151
Phase 4 137
Not applicable 1,796
Observational 320
Expanded access 1

How many Sleep Initiation and Maintenance Disorders trials are recruiting? (10)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 247
Recruiting 338
Enrolling by invitation 39
Active, not recruiting 82
Completed 1,512

Showing 5 of 10 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Sleep Initiation and Maintenance Disorders trials? (4)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
VA Office of Research and Development 49
Takeda 25
Merck Sharp & Dohme LLC 20
Sanofi 18

Which drugs are being tested for Sleep Initiation and Maintenance Disorders? (4)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Ramelteon 35
Trazodone 13
DEXMEDETOMIDINE 12
YZJ-1139 9

Interventions as named in the registry (11)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Zolpidem MR 57
Eszopiclone 3 mg QHS 43
Low Dose Suvorexant 38
Melatonin PR 26
Lemborexant Pill 22

Showing 5 of 11 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Sleep Initiation and Maintenance Disorders trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Hospitalization / Death 62 1
Death 31 3
Surgeries/Procedures 30 1
Surgical and medical procedures 10 1
Pneumonia 9 8

Showing 5 of 10 adverse events.

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Which publications cover Sleep Initiation and Maintenance Disorders? (1,952)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Exploring the Relationship Between Insomnia and Biological Factors, Substance Use, and Physical Activity in People With HIV in the United States: Insights From the PROSPER Study. The Journal of the Association of Nurses in AIDS Care : JANAC 2026 Yes
Greater adherence to healthful dietary patterns is associated with lower insomnia risk in the Women's Health Initiative Observational Study. Sleep 2026 Yes
Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women. Contemporary clinical trials 2026 Yes
Anxiety sensitivity in late-life depression. Links to cognitive impairment, insomnia, and health-related quality of life. Journal of psychiatric research 2026 Yes
A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder. Sleep medicine 2026 Yes

Showing 5 of 1,952 publications.

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Sub-conditions in MeSH (1)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

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