Vitamin B12 and insomnia symptoms

Useful facts when choosing a product

• This is an independent sleep question concerning vitamin B12.
• The principal descriptive record names cyanocobalamin in its conclusion.
• Actual route,formulation,all actives and dose are unverified.

What the research actually shows

# Vitamin B12 and insomnia symptoms

## A 30-second answer Within the sources actually accessible in this task, a direct controlled effect establishing that vitamin B12 improves insomnia in adults was not verified. The nearest treatment record describes sleep quality before and after treatment in B12-deficient patients. Mean PSQI fell from9.77 to4.31 at two months, but a concurrent comparator, actual route/dose and adult-insomnia eligibility were not established. [S01–S02]

This is a **completed, ungraded evidence report for a new independent question**. Efficacy grade, score and all seven scoring axes are null, not F0, an exact null effect or demonstrated safety. It is a separate reports-format output rather than a normal efficacy verdict. No clinical follow-up task is delegated.

## Separate the question from the observation The original question asks what effects, differences or risks relate vitamin B12 to insomnia symptoms in adults with such symptoms. The queue’s single-agent oral formulation, ISI and placebo are proposed investigation fields, not verified study facts. The principal record describes238 patients with serum B12<200ng/L and names cyanocobalamin in its conclusion. Age and directness to diagnosed insomnia remain unverified. [S01]

The **single descriptive primary endpoint is the two-month PSQI sleep-quality score**, with lower scores in the favorable direction. This accessible record was selected because it jointly provides B12 treatment and numerical patient-centered sleep measurements. Selection was editorial, after searching and before report authoring; it is not a claim that an original registered primary endpoint was verified. PSQI is not relabeled ISI, sleep latency, objective efficiency or melatonin phase. SF-36 quality of life and blood B12 are not the principal insomnia endpoint. [S01]

## Human evidence table | Study and access | Actual comparison/population | Endpoint and time | Verified finding and boundary | |---|---|---|---| | Durmaz2024,S01/S02; author-institution abstract; publisher full text403 |238 patients reported with B12<200ng/L,before/after; age,route,dose and full composition unknown | PSQI,two months | Means9.77±5.01 to4.31±3.59. SD/SE meaning of±unknown. No concurrent-comparator effect or CI. | | Djokic2019,S03; PubMed primary abstract |60 insomnia patients,30 per combination/control arm | AIS,three months | Improvement reported, but melatonin,magnesium,B6 and folate accompany B12; not an isolated B12 effect. | | Bouloukaki2023,S04; PubMed primary abstract |512 adults,cross-sectional serum-level comparison | AIS insomnia symptoms,assessment visit | For B12<342pg/mL,aOR2.434(95%CI1.331–4.452),P=.004; not supplementation efficacy or future incidence risk. | | Same Bouloukaki family,S04 | Same sample,different outcome | PSQI sleep quality,same visit | OR1.416(95%CI0.678–2.958),P=.354. Not counted as another independent study. | | Takahashi1999,S05; relevant primary full-text sections | Delayed-phase/non-24-hour disorders,high versus low methylcobalamin dose | Sleep-wake/clinical ratings,4 and8weeks | Selected-time/item signals and nonsignificant overall improvement are distinguished; not an ordinary insomnia scale or isolated oral-versus-placebo effect. | | Mayer1996,S06; primary abstract |20 healthy volunteers,cyano versus methyl forms | Sleep time/alertness,14days | Shorter sleep and alerting with methylcobalamin do not demonstrate insomnia relief. | | InfantRCT2022,S07; primary abstract | Infants | Actigraphic sleep | Excluded from adult-insomnia evidence. |

## Numbers, denominators and interpretation The principal record’s238 is an abstract study count, not a separately verified visit-specific PSQI denominator or paired complete-case count.4.31−9.77=−5.46 points is a **simple subtraction of reported rounded means**. It is not established as the mean of individual changes, a net comparator effect, an adjusted effect or a clinically important change. Exact PSQI P is null because the Results/Conclusion statements do not unambiguously identify its contrast. P=.02/P<.05/P<.001 are not combined by selecting the smallest value. [S01]

A crossover design/washout is not reported; original registration,SAP,imputation,multiplicity and control of co-treatment are not established. No paired t-test,adjusted regression,meta-analysis,standardized effect,CI,MCID or NNT was recomputed. Arithmetic receipts do not represent newly reported inferential statistics from the original paper.

The B12 amount in S03 is16μg,with other active ingredients whose effects cannot be separated. A pre-bedtime combination exposure is not an independently optimal B12 administration time. The abstract’s mixed median/± wording for the control and printed P=0.000 are retained in a separate extraction,not silently corrected or interpreted as an exact zero probability. [S03]

The342pg/mL threshold in S04 is its sample median. A cross-sectional association below that value establishes neither deficiency diagnosis,causality,response to supplementation nor prospective incidence risk. Its nonsignificant PSQI result is also retained. Different scales,populations and interventions are not treated as confirmatory/contradictory versions of the same comparison. [S04]

## Why no numerical grade is assigned Section4.1 of the supplied multidimensional-classification policy requires claim-identity fields including route,population and comparator before a normal efficacy page is created. The route-unverified B12 before/after record cannot be asserted to be a single-agent oral comparison in adults with insomnia. This is not automatic non-grading merely because evidence is observational: the supplied observational/B2 workaround was read. That workaround does not supply missing route,formulation or directly eligible population facts.

The output is completed under `grading_status=not_applicable_or_policy_missing`,specifically **mandatory-claim-identity applicability exclusion**. No new policy or false no-human-study projection is introduced. The original calculator was read and preserved, but clinical functions/CLI were not executed. All four decision receipts accurately contain nonperformance,nulls and reasons; the numerical anchor is also null. Document quality,safety and ungraded efficacy are separate.

## Seven assessment explanations

1. Directness — The anchor concerns sleep quality in deficient patients, not a verified single-agent oral trial in adults with insomnia. The directly requested controlled effect is unknown.

2. Clinical magnitude — A difference of reported means can be described but is not a comparator effect, remission or MCID. Unknown efficacy is distinct from no effect.

3. Replication — No independent matching PSQI/two-month/route comparison was established. Healthy, circadian and combination studies do not count as matching replications.

4. Credibility and bias — The described before/after design, subjective scale and unknown background treatment limit causal attribution. Nonreporting is not failed blinding or zero events.

5. Precision and statistics — Exact PSQI P/CI, dispersion definition and paired sample size are unavailable. No inferential reanalysis was performed; arithmetic is separate.

6. Safety — Event ascertainment and denominators for the sleep record are unavailable, so safety is Unknown. Reused general warnings or other-form safety are not trial-specific evidence.

7. Applicability and reporting quality — Known/unknown values, access failures, full bilingual text and applicability exclusion are disclosed. Document qualityA is not confirmed efficacy or independent external certification.

## Reasons for all seven null scoring axes

**claim_type: null.** The question is clinical, but this output is a separate report because mandatory identity conditions are unmet. All scoring axes remain null.

**endpoint: null.** The descriptive endpoint is two-month PSQI sleep quality, not ISI, a verified registered primary or objective sleep. P is not partially filled to simulate a graded verdict.

**replication: null.** The selected before/after record differs from combination, healthy-volunteer and circadian studies. It is not promoted to a confirmatory RCT, nor are incomparable findings labeled R0/RX.

**independence: null.** Funding, product supply and conflicts for the principal study are unknown. Academic affiliation does not establish I2; I1 is also not adopted as an execution input for this ungraded report.

**effect: null.** The descriptive mean difference is−5.46 points, not a controlled B12 effect or an MCID. No E+,E0,E− or grade-forcing EX is assigned.

**bias: null.** The causal limitations of no reported concurrent comparator and self-report are discussed. Inaccessible details are not manufactured into a counted defect profile.

**precision: null.** A comparator-effect CI/SE and paired covariance are unavailable. Precision/equivalence is not calculated; null and the reason are retained.

## Twelve classification facets

**kind** — S

**canonical_entity** — Vitamin B12; the principal descriptive record names cyanocobalamin in its conclusion

**source_part** — Manufacturing source and origin unverified

**formulation** — Actual formulation and all actives unverified; not confirmed single-ingredient oral treatment

**route** — Unverified: mandatory efficacy-page identity exclusion; neither oral nor injection is assumed

**dose** — Unverified; doses from other studies are not transferred

**duration** — Principal assessment two months after treatment; actual dose-level exposure and interruption unknown

**population** — 238 patients reported with B12<200ng/L; adult-only scope, insomnia diagnosis and paired denominator unverified

**claim** — B12 effects in adults with insomnia symptoms; deficient-patient sleep-quality before/after observations do not establish treatment efficacy

**primary_endpoint** — Descriptive endpoint:two-month mean PSQI score; original registered primary unknown

**comparator** — Same-cohort pretreatment measure; no concurrent placebo/untreated arm in accessible abstract

**duplicate_key** — REPORT|B12|route-unverified|low-B12|PSQI|2months|before-after; not a publishable permanent code

## Safety and applicability The safety label is **Unknown**. Event ascertainment,denominators and withdrawals in the principal record are not established; nonreporting is not zero events or demonstrated safety. Previously completed NIH/MHRA general B12 safety context is reused unchanged,not transferred into a sleep-study incidence rate or equivalent risk across molecular forms. Deficiency correction differs from additional supplementation for insomnia in nondeficient adults. Oral,injectable and combination results are not pooled. Research exposures are not instructions for personal supplementation,injection or changing hypnotics. [S01,S03,S06,R01–R02]

## All unresolved and nonapplicable information

### U01 · Age and adult-only scope — inaccessible The accessible abstract says238 patients without an age range; it is not relabeled238 adults. Source: S01/S02.

### U02 · Insomnia diagnosis and entry criteria — not_reported PSQI sleep-quality measurement is established, but no insomnia diagnosis, ISI/AIS entry threshold or chronicity is given. Source: S01.

### U03 · Actual administration route — inaccessible Naming cyanocobalamin does not establish oral, intramuscular or intravenous administration. This identity gap is central to excluding a normal efficacy page. Source: S01/S02.

### U04 · Single ingredient and full product composition — inaccessible The abstract phrase B12 treatment does not verify all actives, formulation, brand, batch or excipients. Source: S01/S02.

### U05 · Dose, frequency, clock time and adherence — inaccessible Daily dose, frequency, timing relative to food/bedtime and cumulative exposure are unverified. Doses from other studies are not transferred. Source: S01/S02.

### U06 · Concurrent comparator — not_reported The reported contrast is before versus two months after treatment. The abstract supplies no randomized or concurrent untreated/placebo arm; absence from the inaccessible full text is not asserted. Source: S01.

### U07 · Recruitment, analysis, completion and attrition — inaccessible 238 is the abstract study count. Paired PSQI complete cases, visit-specific denominators and reasons for attrition are unknown. Source: S01/S02.

### U08 · Registration, original primary outcome and SAP — inaccessible Registry identifier/fields/amendments and the analysis plan were not obtained. The page-selected PSQI is not called a registered primary outcome. Source: S01/S02.

### U09 · Meaning of ± — not_reported The abstract does not define5.01/3.59 or1.87/1.42 as SD or SE. The printed notation is retained without conversion. Source: S01.

### U10 · Exact endpoint P — conflicting Results give P=.02/P<.05 while the conclusion mentions P<.001 without unambiguous contrast attribution. No single P is assigned to the PSQI change. Source: S01.

### U11 · Between-group effect, CI and model SE — not_reported No independent-comparator effect, adjusted estimate or CI is available. The−5.46-point difference of rounded means is not a between-group estimate. Source: S01.

### U12 · Paired-change variance and covariance — not_reported No IPD, change SD or baseline/follow-up covariance is available; no paired test or CI was reanalyzed. Source: S01.

### U13 · Applicable MCID — not_reported No validated MCID for this deficient population and treatment comparison was established. A PSQI classification cutoff or another insomnia-scale threshold is not its MCID. Source: S01.

### U14 · PSQI version, implementation and reliability — inaccessible The reported PSQI score is treated as the overall score, but translation, recall window, administration, scoring, item-missing handling and study-specific reliability are unknown. Source: S01/S02.

### U15 · Diary, actigraphy and PSG — not_reported Objective sleep monitoring is not established in the abstract. PSQI/reported sleep duration is not relabeled actigraphy, PSG or melatonin phase. Source: S01.

### U16 · Latency, awakenings and efficiency estimates — not_reported A narrative shortening of time to sleep is reported without a numerical effect, unit or CI; no subcomponent estimate is invented. Source: S01.

### U17 · Hypnotics, light, behavioral and depression treatments — inaccessible Common/changed hypnotics, light, CBT, antidepressants, other vitamins, exercise and diet are unknown; improvement is not attributed solely to B12. Source: S01/S02.

### U18 · Deficiency cause, assay and comorbidity — inaccessible Beyond the<200ng/L criterion, assay, anemia, malabsorption, depression, neurological disease and shift-work/circadian exclusions are unknown. Source: S01/S02.

### U19 · Design, blinding, confounding and multiplicity — inaccessible The described before/after comparison lacks a reported concurrent control and uses a subjective outcome. Inaccessible details are not labeled failed randomization or confirmed absence of adjustment. Source: S01/S02.

### U20 · Crossover and washout — not_applicable The selected record describes before/after measurement, not a reported crossover trial. Washout is not assigned a fabricated zero. Source: S01.

### U21 · Funding, product supply and conflicts — inaccessible University affiliation is not evidence of independent funding. Funding, product provision and conflict declarations were not verified. Source: S01/S02.

### U22 · Adverse events, withdrawal and arm denominators — not_reported The sleep-study abstract lacks event-specific denominators, causality and withdrawal details. Nonreporting is neither zero events nor demonstrated safety. Source: S01.

### U23 · Long-term and special-population safety — not_searched Pregnancy, children, severe hepatic/renal disease and long-term exposure safety were not newly researched for this insomnia question. Preserved safety context is not a substitute. Source: S01.

### U24 · Correction and retraction scope — inaccessible Title/ingredient searches and accessible screens were checked but many results were irrelevant or inaccessible. No newly verified notice is not comprehensive clearance. Source: S01–S07.

### U25 · Combination control and dispersion wording — inaccessible S03 uses median together with± for a control value and does not sufficiently specify control treatment, blinding or deficiency status. No silent correction substitutes for the paper. Source: S03.

### U26 · Full observational adjustment set and denominators — inaccessible The aOR is retained as reported. Complete covariates, model-specific missingness denominators and multiplicity were not verified.342pg/mL is the study median, not a deficiency diagnosis. Source: S04.

### U27 · Directness of circadian/healthy-subject findings — not_applicable Delayed phase/non-24-hour disorders and alerting in healthy volunteers are not pooled with ordinary insomnia treatment, or counted as matching contradiction/replication. Source: S05/S06.

### U28 · Additional and recent literature leads — inaccessible Searches surfaced2022 healthy-supplementation/diabetes-observation and2026 acupoint leads, but exact primary full records were not obtained. Review-cited numbers or preliminary title classification do not fill effects. Source: search_log.json.

### U29 · Advertising copy — not_searched This is a research question; no specific advertising copy was collected. what_ads=null. Source: input.

### U30 · Normal efficacy-format mapping — not_applicable A direct claim satisfying mandatory identity fields in classification4.1 and the calculator contract is not established, so this is a separate report. Evidence limitations are not no-human-evidence; there is no clinical TODO. Source: policy_exclusion.json.

### U31 · New publication identifiers — not_applicable New ID/site_id/slug/URL/semantic code/first publication are unreserved null. TASK-1053 is not site1053. Source: input.

## Reuse, verification and current completion The full3167-record semantic index and actual comparison boundaries in12 supplied B12 originals were compared; no exact completed insomnia claim was identified. Reused IDs are110,1059,1340,1440,3111–3114 and3164–3167. OPEN,B-PROOF,JETALS and depression studies were not regraded as sleep evidence; earlier D28/C50 values are not inherited. All426 input members and396 selected original files from eight prior packages remain byte-for-byte intact. Entire previous archives are not claimed to have been supplied.

Document quality is **A**; result `completed_with_uncertainty`,editorial status `ready_with_uncertainty`,format mapping `needs_format_mapping`. This A is a same-model assessment against the supplied reporting criteria,not efficacy,safety or external certification. Source,numeric,boundary and bilingual review was performed by the same model; `independent=false`. Initial public corrections are `corrections=[]`; actual pre-submission errors and decision changes are in the separate audit. All new publication identifiers are null. There is no clinical TODO. Work ends at this final original-content handoff.

## Sources and display paths Direct URLs,identifiers,access levels and locations for S/R sources are in `sources.json`; principal values in `extractions/primary_endpoint.json`; actual execution/nonexecution receipts in `receipts/`; preserved originals in `inputs/`. This entire body equals `reports/TASK-1053.json#/en/body_markdown` and `/en/what_research` and is displayed from `publication.en.md`. No new site URL is reserved.

Why this is classified as Unscored

Human sleep data exist. However, route/full formulation and directness to adult insomnia in the selected B12-treatment record are not established, so mandatory identity conditions for a normal efficacy page are unmet. Rather than substitute another population/combination to obtain a grade, a completed ungraded evidence report is the current deliverable.

Counterpoint. An unverified direct effect is not no effect, equivalence or demonstrated safety.

Rejudgment record. not_applicable — Human sleep data exist. However, route/full formulation and directness to adult insomnia in the selected B12-treatment record are not established, so mandatory identity conditions for a normal efficacy page are unmet. Rather than substitute another population/combination to obtain a grade, a completed ungraded evidence report is the current deliverable.

Review performed and remaining limitations

The accessible abstract says238 patients without an age range; it is not relabeled238 adults. PSQI sleep-quality measurement is established, but no insomnia diagnosis, ISI/AIS entry threshold or chronicity is given. Naming cyanocobalamin does not establish oral, intramuscular or intravenous administration. This identity gap is central to excluding a normal efficacy page. The abstract phrase B12 treatment does not verify all actives, formulation, brand, batch or excipients. Daily dose, frequency, timing relative to food/bedtime and cumulative exposure are unverified. Doses from other studies are not transferred. The reported contrast is before versus two months after treatment. The abstract supplies no randomized or concurrent untreated/placebo arm; absence from the inaccessible full text is not asserted. 238 is the abstract study count. Paired PSQI complete cases, visit-specific denominators and reasons for attrition are unknown. Registry identifier/fields/amendments and the analysis plan were not obtained. The page-selected PSQI is not called a registered primary outcome. The abstract does not define5.01/3.59 or1.87/1.42 as SD or SE. The printed notation is retained without conversion. Results give P=.02/P<.05 while the conclusion mentions P<.001 without unambiguous contrast attribution. No single P is assigned to the PSQI change. No independent-comparator effect, adjusted estimate or CI is available. The−5.46-point difference of rounded means is not a between-group estimate. No IPD, change SD or baseline/follow-up covariance is available; no paired test or CI was reanalyzed. No validated MCID for this deficient population and treatment comparison was established. A PSQI classification cutoff or another insomnia-scale threshold is not its MCID. The reported PSQI score is treated as the overall score, but translation, recall window, administration, scoring, item-missing handling and study-specific reliability are unknown. Objective sleep monitoring is not established in the abstract. PSQI/reported sleep duration is not relabeled actigraphy, PSG or melatonin phase. A narrative shortening of time to sleep is reported without a numerical effect, unit or CI; no subcomponent estimate is invented. Common/changed hypnotics, light, CBT, antidepressants, other vitamins, exercise and diet are unknown; improvement is not attributed solely to B12. Beyond the<200ng/L criterion, assay, anemia, malabsorption, depression, neurological disease and shift-work/circadian exclusions are unknown. The described before/after comparison lacks a reported concurrent control and uses a subjective outcome. Inaccessible details are not labeled failed randomization or confirmed absence of adjustment. The selected record describes before/after measurement, not a reported crossover trial. Washout is not assigned a fabricated zero. University affiliation is not evidence of independent funding. Funding, product provision and conflict declarations were not verified. The sleep-study abstract lacks event-specific denominators, causality and withdrawal details. Nonreporting is neither zero events nor demonstrated safety. Pregnancy, children, severe hepatic/renal disease and long-term exposure safety were not newly researched for this insomnia question. Preserved safety context is not a substitute. Title/ingredient searches and accessible screens were checked but many results were irrelevant or inaccessible. No newly verified notice is not comprehensive clearance. S03 uses median together with± for a control value and does not sufficiently specify control treatment, blinding or deficiency status. No silent correction substitutes for the paper. The aOR is retained as reported. Complete covariates, model-specific missingness denominators and multiplicity were not verified.342pg/mL is the study median, not a deficiency diagnosis. Delayed phase/non-24-hour disorders and alerting in healthy volunteers are not pooled with ordinary insomnia treatment, or counted as matching contradiction/replication. Searches surfaced2022 healthy-supplementation/diabetes-observation and2026 acupoint leads, but exact primary full records were not obtained. Review-cited numbers or preliminary title classification do not fill effects. This is a research question; no specific advertising copy was collected. what_ads=null. A direct claim satisfying mandatory identity fields in classification4.1 and the calculator contract is not established, so this is a separate report. Evidence limitations are not no-human-evidence; there is no clinical TODO. New ID/site_id/slug/URL/semantic code/first publication are unreserved null. TASK-1053 is not site1053.

Evidence Table

| Study and access | Actual comparison/population | Endpoint and time | Verified finding and boundary | |---|---|---|---| | Durmaz2024,S01/S02; author-institution abstract; publisher full text403 |238 patients reported with B12<200ng/L,before/after; age,route,dose and full composition unknown | PSQI,two months | Means9.77±5.01 to4.31±3.59. SD/SE meaning of±unknown. No concurrent-comparator effect or CI. | | Djokic2019,S03; PubMed primary abstract |60 insomnia patients,30 per combination/control arm | AIS,three months | Improvement reported, but melatonin,magnesium,B6 and folate accompany B12; not an isolated B12 effect. | | Bouloukaki2023,S04; PubMed primary abstract |512 adults,cross-sectional serum-level comparison | AIS insomnia symptoms,assessment visit | For B12<342pg/mL,aOR2.434(95%CI1.331–4.452),P=.004; not supplementation efficacy or future incidence risk. | | Same Bouloukaki family,S04 | Same sample,different outcome | PSQI sleep quality,same visit | OR1.416(95%CI0.678–2.958),P=.354. Not counted as another independent study. | | Takahashi1999,S05; relevant primary full-text sections | Delayed-phase/non-24-hour disorders,high versus low methylcobalamin dose | Sleep-wake/clinical ratings,4 and8weeks | Selected-time/item signals and nonsignificant overall improvement are distinguished; not an ordinary insomnia scale or isolated oral-versus-placebo effect. | | Mayer1996,S06; primary abstract |20 healthy volunteers,cyano versus methyl forms | Sleep time/alertness,14days | Shorter sleep and alerting with methylcobalamin do not demonstrate insomnia relief. | | InfantRCT2022,S07; primary abstract | Infants | Actigraphic sleep | Excluded from adult-insomnia evidence. |

Receipt — 9 References

Evidence access cutoff: 2026-09-18. Each citation states its actual access level (full-text transcription, abstract, index, or other) and remaining limitations. Bibliographic checking does not certify the study results or treatment efficacy.

What this document does and does not do

Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.