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Research · Medication

Over-the-counter sleep aids

A network meta-analysis found doxylamine improved self-rated sleep more than placebo in short-term treatment. Diphenhydramine trials found small gains, with no change on overnight sleep recordings, and sleepiness on it matched placebo by day 4 in one trial. Long-term use of strong anticholinergic drugs, a group that includes these antihistamines, was linked to dementia in older adults.

Add to Bio HackChecked 2026-11-14
Status
Sold over the counter in the US as nighttime sleep aids for occasional sleeplessness, for adults and children 12 and older. Diphenhydramine sleep aids and Tylenol PM are labeled as OTC monograph drugs, while Unisom SleepTabs (doxylamine) and Advil PM are sold over the counter under FDA-approved applications. Doxylamine with pyridoxine (Diclegis) is a separate prescription drug for nausea and vomiting of pregnancy.
Also called
doxylamine, doxylamine succinate, Unisom SleepTabs, ZzzQuil Ultra, diphenhydramine, diphenhydramine hydrochloride, diphenhydramine citrate, ZzzQuil, Unisom SleepGels, Tylenol PM, Advil PM, Aleve PM, Unisom PM Pain, ZzzQuil Night Pain, PM pain relievers, nighttime sleep aids, antihistamine sleep aids
Taken for
sleep, insomnia, falling asleep, staying asleep, occasional sleeplessness, sleep with aches and pains, helping children sleep

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help3

Reported risks10

What people take it for, and what was found

Shown to help3

Moderate

Sleep in adults with insomnia, doxylamine

Shown to improve self-rated sleep quality more than placebo in short-term treatment of adults with insomnia, in a network meta-analysis of 154 trials.

Compared with placebo [1][2]; acetaminophen alone [2]

The numbers and sources
Effect
In acute treatment, doxylamine was one of seven drugs or drug groups that improved self-rated sleep quality more than placebo, with standardized mean differences across those seven of 0.36 to 0.83 and high to moderate certainty [1]. In a randomized double-blind trial in postoperative patients, doxylamine 25 mg was superior to placebo on 12 sleep measures. Combined with acetaminophen 1 g, it gave more benefit than either drug alone. Patients on doxylamine reported feeling drugged [2].
Population
154 double-blind randomized trials with 44,089 adults with insomnia disorder, 30 interventions [1]; 2,931 postoperative patients, 1,617 with mild or moderate pain and 1,314 without pain [2].
Sources
[1], [2]
Caveats
The network meta-analysis abstract gives a range across seven drugs, not doxylamine's own effect size, and reports no long-term data for doxylamine [1]. The postoperative trial measured sleep by interview and medical records, and was published in 1985 [2].
Limited

Sleep in older adults, diphenhydramine

One crossover trial in adults over 70 found diphenhydramine 50 mg reduced only night awakenings against placebo, 1.7 against 2.0 a night.

Compared with placebo [6][7]; temazepam 15 mg [6]

The numbers and sources
Effect
Over 14 nights, diphenhydramine 50 mg reduced the number of awakenings against placebo (mean 1.7 against 2.0 a night). Sleep quality, total sleep time and sleep onset latency improved on temazepam 15 mg but not on diphenhydramine. Adverse event counts were similar across treatments [6]. A systematic review of 5 studies in people 65 and older found diphenhydramine raised sedation and lowered the number of awakenings [7].
Population
Older adults with insomnia, mean age 73.9, range 70 to 89, in a randomized crossover trial [6]; 5 outpatient studies in people 65 and older [7].
Sources
[6], [7]
Caveats
Very few trials in older adults [7]. Two weeks of treatment only [6].
Limited

Sleep with pain, PM combinations

Industry-funded trials found naproxen with diphenhydramine 50 mg improved sleep more than either drug alone after dental surgery. The version with diphenhydramine 25 mg did not.

Compared with naproxen sodium alone and diphenhydramine alone [8]; doxylamine alone, acetaminophen alone and placebo [2]

The numbers and sources
Effect
In people with pain after dental surgery and a sleep schedule shifted 5 hours to induce insomnia, naproxen sodium 440 mg with diphenhydramine 50 mg cut wake time after sleep onset by 70.3 minutes more than naproxen alone, and sleep latency was 25.5 minutes against 41.5 minutes on diphenhydramine alone. Naproxen 440 mg with diphenhydramine 25 mg showed no improvement over either component [8]. In postoperative patients, doxylamine 25 mg with acetaminophen 1 g gave more sleep benefit than either drug alone or placebo, and in patients with pain the analgesic contributed more than the sedative [2].
Population
712 and 267 adults in two randomized double-blind trials after dental impaction surgery, sleep measured by actigraphy [8]; 2,931 postoperative patients [2].
Sources
[8], [2]
Caveats
Both dental trials were sponsored by the maker of a naproxen and diphenhydramine product, and four authors were its employees [8]. These are single-night or short-term studies in acute pain. No trial of the ibuprofen or acetaminophen combinations with diphenhydramine was sourced.

Mixed results1

Limited

Sleep in adults with mild insomnia, diphenhydramine

Small trials found diphenhydramine gave modest gains in diary sleep efficiency, with no difference from placebo on overnight sleep recordings. A review called the trial results mixed.

Compared with placebo [3][4]; a valerian and hops combination [3]

The numbers and sources
Effect
Over 14 days, diphenhydramine 50 mg raised diary sleep efficiency more than placebo, with a trend toward longer total sleep time and lower insomnia severity ratings. Polysomnography found no group difference on any sleep continuity measure, and no rebound insomnia followed stopping [3]. A systematic review of 16 randomized trials of H1 antihistamines found mixed results limited by sample size, and stated that tolerance develops rapidly [4]. The American Academy of Sleep Medicine, using GRADE, suggested clinicians not use diphenhydramine for sleep onset or sleep maintenance insomnia, graded as weak [5].
Population
184 adults with mild insomnia, 110 women and 74 men, mean age 44.3, in 9 US sleep centers [3]; 16 randomized trials in adults, including older adults [4]; randomized trials reviewed for a clinical guideline [5].
Sources
[3], [4], [5]
Caveats
Few small, short trials. The guideline abstract does not give diphenhydramine's effect sizes [5].

Not shown to help1

LimitedStudied in children

Infant night waking

One small trial in infants aged 6 to 15 months found diphenhydramine did not reduce night waking more than placebo. It was stopped early.

Compared with placebo [9]

The numbers and sources
Effect
Over one week of treatment and at 2 and 4 weeks after, 1 of 22 infants on diphenhydramine improved in night awakenings needing a parent, against 3 of 22 on placebo. Parental happiness with sleep did not differ. The data safety monitoring board stopped the trial for lack of effect [9].
Population
44 infants aged 6 to 15 months with frequent night awakenings [9].
Sources
[9]
Caveats
One small trial. The over-the-counter labels say not to use these sleep aids under age 12 [10][11].

Doses studied

The network meta-analysis does not give doxylamine doses in its abstract [1]. The postoperative trial used doxylamine succinate 25 mg, alone or with acetaminophen 1 g [2], the same amount as one Unisom SleepTabs tablet, which the label directs once daily 30 minutes before bed [10]. The adult and older adult insomnia trials used diphenhydramine 50 mg at bedtime, given as two 25 mg tablets in one trial, for 14 days [3][6]. The tolerance trial used diphenhydramine 50 mg twice a day for 4 days [12], and the PET study used one 50 mg dose at 11 pm [13]. A ZzzQuil liquid dose is diphenhydramine HCl 50 mg in 30 mL, one dose in 24 hours [11]. Two Tylenol PM caplets hold acetaminophen 1,000 mg and diphenhydramine HCl 50 mg [14], and two Advil PM caplets hold ibuprofen 400 mg and diphenhydramine citrate 76 mg, no more than 2 caplets in 24 hours [15]. The dental pain trials used naproxen sodium 440 mg with diphenhydramine 50 or 25 mg [8].

Risks

Reported risks8

LimitedStudied in menHow often is not known

Tolerance to the sedative effect

One small trial in healthy men found sleepiness and impaired performance on diphenhydramine 50 mg twice daily on day 1 were gone by day 4.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Objective and subjective sleepiness were higher on diphenhydramine than placebo on day 1. By day 4, sleepiness on diphenhydramine could not be told apart from placebo, and the performance impairment seen on day 1 had reversed. The authors concluded tolerance was complete by the end of 3 days [12].
Population
15 healthy men aged 18 to 50 in a randomized double-blind crossover trial [12].
Sources
[12]
Caveats
Daytime dosing in people without insomnia. Other antihistamines and dosing schedules may differ [12].
LimitedHow often is not known

Delirium in hospitalized older adults

Linked to delirium symptoms in hospitalized adults aged 70 and older, at 1.7 times the risk, with more urinary catheters and longer stays, in one cohort.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Patients given diphenhydramine in hospital had a higher risk of any delirium symptom (RR 1.7, 95% CI 1.3 to 2.3), including inattention (RR 3.0), disorganized speech (RR 5.5) and altered consciousness (RR 3.1). Urinary catheter placement was more likely (RR 2.5, 95% CI 1.0 to 6.0) and median length of stay was longer (7 against 6 days). Most outcomes showed a dose-response relationship [16].
Population
426 hospitalized medical patients aged 70 and older, 114 of whom received diphenhydramine [16].
Sources
[16]
Caveats
Observational. Diphenhydramine was given in hospital, not taken as a home sleep aid [16].
StrongHow often is not known

Dementia with long-term strong anticholinergic use

Linked to higher dementia risk in older adults, about 1.2 to 1.5 times, with more risk at higher cumulative use, in three meta-analyses of observational studies.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Any anticholinergic use was associated with incident dementia (OR 1.20, 95% CI 1.09 to 1.32), and use of 365 days or more with an OR of 1.50 (95% CI 1.22 to 1.85). It was also associated with cognitive decline (SMD 0.15) [17]. Use for 3 months or more gave a rate ratio of 1.46 (95% CI 1.17 to 1.81) against nonuse [18]. A third meta-analysis found a dose-dependent association with all-cause dementia and Alzheimer disease [19]. In one cohort, first-generation antihistamines were among the most used strong anticholinergics, and the highest cumulative use (over 1,095 standard daily doses) gave an HR of 1.54 (95% CI 1.21 to 1.96) [20].
Population
26 studies with 621,548 participants [17]; 6 studies in a pooled analysis [18]; 14 studies with 1,564,181 subjects [19]; 3,434 adults aged 65 and older followed a mean 7.3 years [20].
Sources
[17], [18], [19], [20]
Caveats
All observational, with considerable risk of bias, so a causal link cannot be inferred [17]. Heterogeneity was high in some pooled estimates (I² 86 to 90%) [17]. These estimates are for anticholinergic drugs as a group, not for diphenhydramine or doxylamine alone.
LimitedHow often is not known

Overdose

FDA warns that more diphenhydramine than the label directs can cause serious heart problems, seizures, coma or death. In doxylamine overdose, muscle breakdown occurred in 59% of patients.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
FDA stated that taking more diphenhydramine than the label directs can lead to serious heart problems, seizures, coma or death, after reports of teenagers in emergency rooms or dying after a social media challenge [23]. In a prospective study of doxylamine overdose, 16 of 27 patients developed rhabdomyolysis and 3 of those 16 developed acute kidney failure. Ingesting 20 mg/kg or more predicted rhabdomyolysis, which occurred in 87% of those patients [24]. The ZzzQuil label limits use to one dose in 24 hours and the doxylamine label warns against any other doxylamine product [11][10].
Population
Reports reviewed by FDA [23]; 27 patients admitted for doxylamine overdose at one Korean hospital [24].
Sources
[23], [24], [11], [10]
Caveats
The rates are among people who overdosed, not among users. FDA's statement gives no denominator [23].
LimitedHow often is not known

Interactions with alcohol, sedatives and blood thinners

The labels warn against alcohol and ask people on sedatives, tranquilizers or other antihistamines to consult first. The PM pain labels add warfarin and other blood thinners.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
The doxylamine and diphenhydramine sleep-aid labels say to avoid alcohol and to ask a doctor or pharmacist before use with sedatives, tranquilizers or, for doxylamine, other antihistamines or sleep aids [10][11]. The Tylenol PM label adds the blood thinner warfarin [14]. The Advil PM label states the chance of severe stomach bleeding is higher with a blood thinning or steroid drug, and that ibuprofen may decrease the heart protection of aspirin [15]. The prescription doxylamine label states that combining it with alcohol or other central nervous system depressants may cause severe drowsiness leading to falls or accidents [27].
Population
Labeling statements [10][11][14][15][27].
Sources
[10], [11], [14], [15], [27]
Caveats
No rate of harm is given.
LimitedHow often is not known

Conditions the labels name

The labels ask people with glaucoma, trouble urinating from an enlarged prostate, or breathing problems such as emphysema to consult a doctor before use.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
The doxylamine and diphenhydramine sleep-aid labels list a breathing problem such as emphysema or chronic bronchitis, glaucoma, and trouble urinating due to an enlarged prostate as reasons to ask a doctor first [10][11]. The prescription doxylamine label attributes these cautions to its anticholinergic properties [27].
Population
Labeling statements [10][11][27].
Sources
[10], [11], [27]
Caveats
No rate is given.
LimitedHow often is not known

Liver warning in acetaminophen PM products

The label warns that severe liver damage may occur above 4,000 mg of acetaminophen a day, with other acetaminophen products, or with 3 or more drinks daily.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
The Tylenol PM label carries a liver warning for more than 4,000 mg of acetaminophen in 24 hours, use with other drugs containing acetaminophen, or 3 or more alcoholic drinks a day while using it. It also warns that acetaminophen may cause severe skin reactions and limits use to 2 caplets in 24 hours [14].
Population
Labeling statement [14].
Sources
[14]
Caveats
Applies to the acetaminophen in the combination, not to diphenhydramine.
LimitedHow often is not known

Stomach bleeding, heart attack and stroke warnings in NSAID PM products

The Advil PM label warns that its NSAID may cause severe stomach bleeding and that NSAIDs other than aspirin raise the risk of heart attack, heart failure and stroke.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
The label states the chance of severe stomach bleeding is higher at age 60 or older, with past ulcers or bleeding, with blood thinning or steroid drugs, with other NSAIDs, with 3 or more drinks a day, or with longer or larger use than directed. It states NSAIDs except aspirin increase the risk of heart attack, heart failure and stroke, which can be fatal, and warns against ibuprofen at 20 weeks of pregnancy or later unless a doctor directs it [15].
Population
Labeling statement [15].
Sources
[15]
Caveats
Applies to the ibuprofen in the combination, not to diphenhydramine. No rate is given on the label.

Mixed results2

LimitedHow often is not known

Next-day effects

Mixed results: a PET study found 45% of brain histamine receptors still occupied the morning after a 50 mg bedtime dose, while self-rated sleepiness matched placebo.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
At 11 am after diphenhydramine 50 mg at 11 pm, mean cortical H1 receptor occupancy was 44.7%, against 16.6% after the second-generation antihistamine bepotastine. Subjective sleepiness did not differ from placebo [13]. In a 14-day trial, diphenhydramine produced no significant residual effects [3].
Population
8 healthy men in a placebo-controlled crossover PET study [13]; 184 adults with mild insomnia [3].
Sources
[13], [3]
Caveats
The PET study was very small and did not test driving or performance [13]. The labels warn not to drive or operate machinery and, for doxylamine and Advil PM, not to use without time for a full night's sleep [10][15].
LimitedHow often is not known

Dementia and antihistamines specifically

Mixed results: one large study found no significant rise in dementia with antihistamine prescriptions, while a cohort linked first-generation antihistamines to 1.51 times the risk at the highest use.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
In a nested case-control study, prescribed antihistamines at the highest cumulative exposure (over 1,095 standard daily doses) gave a fully adjusted OR of 1.14 (95% CI 0.98 to 1.34), while antidepressants, bladder antimuscarinics, antipsychotics, antiparkinson and antiepileptic drugs were linked to dementia [21]. In people with allergic rhinitis, first-generation antihistamines were associated with dementia at every level of use, with an adjusted HR of 1.13 below 60 cumulative daily doses and 1.51 (95% CI 1.42 to 1.62) above 120 [22].
Population
58,769 people with dementia and 225,574 matched controls aged 55 and older in English primary care, mean age 82.2 [21]; 677,971 Taiwanese patients with new allergic rhinitis using antihistamines and 36,081 not using them [22].
Sources
[21], [22]
Caveats
Observational. The English study counted prescriptions only, so over-the-counter use was not captured, and few people had high exposure [21]. The Taiwanese study was in allergy use, not sleep use [22].

Checked, no increase found1

ModerateStudied in pregnancy

Pregnancy

Not linked to birth defects after first-trimester exposure, in a meta-analysis of doxylamine combination studies and a second of H1 antihistamines.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Across 16 cohort and 11 case-control studies, first-trimester exposure to Bendectin (doxylamine, dicyclomine and pyridoxine) gave a pooled relative risk of any malformation of 0.95 (95% CI 0.88 to 1.04), with all defect categories enclosing no effect [25]. Across 37 studies of H1 antihistamines, major malformations were not more common in cohort studies (OR 1.07, 95% CI 0.98 to 1.16) or case-control studies (OR 1.05, 95% CI 0.90 to 1.23), and miscarriage (OR 1.00), prematurity (OR 0.96) and low birth weight (OR 1.20, 95% CI 0.63 to 2.29) did not differ [26]. The prescription doxylamine and pyridoxine label states no increased risk of congenital malformations has been reported in epidemiologic studies [27].
Population
27 studies of first-trimester Bendectin exposure [25]; 37 studies of first-trimester H1 antihistamine exposure [26].
Sources
[25], [26], [27]
Caveats
Observational. The doxylamine data come from use for pregnancy nausea at lower daily doses than one sleep tablet. The over-the-counter labels ask pregnant or breast-feeding women to consult a health professional first [10][11].

Claims tested and not found

  1. That diphenhydramine helps infants sleep through the night. In a randomized trial in infants aged 6 to 15 months, 1 of 22 on diphenhydramine and 3 of 22 on placebo improved, and the trial was stopped for lack of effect [9].
  2. That an antihistamine sleep aid keeps its sedative effect with nightly use. In healthy men, sleepiness on diphenhydramine 50 mg twice a day matched placebo by day 4 [12].
  3. That diphenhydramine changes sleep measured overnight in a sleep lab. In adults with mild insomnia, polysomnography showed no difference from placebo on any sleep continuity measure after 14 days [3].

Sources

  1. De Crescenzo F, D'Alò GL, Ostinelli EG, et al. Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis. The Lancet. 2022. https://doi.org/10.1016/s0140-6736(22)00878-9
  2. Smith GM, Smith PH. Effects of doxylamine and acetaminophen on postoperative sleep. Clinical Pharmacology and Therapeutics. 1985. https://doi.org/10.1038/clpt.1985.87
  3. Morin CM, Koetter U, Bastien C, Ware JC, Wooten V. Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial. Sleep. 2005. https://doi.org/10.1093/sleep/28.11.1465
  4. Vande Griend JP, Anderson SL. Histamine-1 receptor antagonism for treatment of insomnia. Journal of the American Pharmacists Association. 2012. https://doi.org/10.1331/japha.2012.12051
  5. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine. 2017. https://doi.org/10.5664/jcsm.6470
  6. Glass JR, Sproule BA, Herrmann N, Busto UE. Effects of 2-week treatment with temazepam and diphenhydramine in elderly insomniacs: a randomized, placebo-controlled trial. Journal of Clinical Psychopharmacology. 2008. https://doi.org/10.1097/jcp.0b013e31816a9e4f
  7. Almond SM, Warren MJ, Shealy KM, Threatt TB, Ward ED. A Systematic Review of the Efficacy and Safety of Over-the-Counter Medications Used in Older People for the Treatment of Primary insomnia. The Senior Care Pharmacist. 2021. https://doi.org/10.4140/tcp.n.2021.83
  8. Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. International Journal of Clinical Practice. 2015. https://doi.org/10.1111/ijcp.12669
  9. Merenstein D, Diener-West M, Halbower AC, Krist A, Rubin HR. The trial of infant response to diphenhydramine: the TIRED study, a randomized, controlled, patient-oriented trial. Archives of Pediatrics & Adolescent Medicine. 2006. https://doi.org/10.1001/archpedi.160.7.707
  10. U.S. Food and Drug Administration. UNISOM SLEEPTABS (doxylamine succinate) tablet, drug facts label. 2026. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ae32d74-76a0-47e2-9e5c-812426413c4e
  11. U.S. Food and Drug Administration. ZZZQUIL NIGHTTIME SLEEP-AID (diphenhydramine hydrochloride) liquid, drug facts label. 2026. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d608c94-1651-f318-e063-6294a90aa11e
  12. Richardson GS, Roehrs TA, Rosenthal L, Koshorek G, Roth T. Tolerance to daytime sedative effects of H1 antihistamines. Journal of Clinical Psychopharmacology. 2002. https://doi.org/10.1097/00004714-200210000-00012
  13. Zhang D, Tashiro M, Shibuya K, et al. Next-day residual sedative effect after nighttime administration of an over-the-counter antihistamine sleep aid, diphenhydramine, measured by positron emission tomography. Journal of Clinical Psychopharmacology. 2010. https://doi.org/10.1097/jcp.0b013e3181fa8526
  14. U.S. Food and Drug Administration. TYLENOL PM EXTRA STRENGTH (acetaminophen and diphenhydramine hydrochloride) tablet, drug facts label. 2026. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce58105b-f010-47af-8f31-6dd4ce4e9cba
  15. U.S. Food and Drug Administration. ADVIL PM (diphenhydramine citrate and ibuprofen) tablet, drug facts label. 2024. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=658fc201-47c9-6a6d-8af9-6208298d43b4
  16. Agostini JV, Leo-Summers LS, Inouye SK. Cognitive and other adverse effects of diphenhydramine use in hospitalized older patients. Archives of Internal Medicine. 2001. https://doi.org/10.1001/archinte.161.17.2091
  17. Pieper NT, Grossi CM, Chan WY, et al. Anticholinergic drugs and incident dementia, mild cognitive impairment and cognitive decline: a meta-analysis. Age and Ageing. 2020. https://doi.org/10.1093/ageing/afaa090
  18. Dmochowski RR, Thai S, Iglay K, et al. Increased risk of incident dementia following use of anticholinergic agents: A systematic literature review and meta-analysis. Neurourology and Urodynamics. 2021. https://doi.org/10.1002/nau.24536
  19. Zheng YB, Shi L, Zhu XM, et al. Anticholinergic drugs and the risk of dementia: A systematic review and meta-analysis. Neuroscience and Biobehavioral Reviews. 2021. https://doi.org/10.1016/j.neubiorev.2021.04.031
  20. Gray SL, Anderson ML, Dublin S, et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Internal Medicine. 2015. https://doi.org/10.1001/jamainternmed.2014.7663
  21. Coupland CAC, Hill T, Dening T, et al. Anticholinergic Drug Exposure and the Risk of Dementia: A Nested Case-Control Study. JAMA Internal Medicine. 2019. https://doi.org/10.1001/jamainternmed.2019.0677
  22. Su CH, Huang KH, Yang Y, et al. Cumulative Dose Effects of H1 Antihistamine Use on the Risk of Dementia in Patients With Allergic Rhinitis. The Journal of Allergy and Clinical Immunology: In Practice. 2024. https://doi.org/10.1016/j.jaip.2024.05.027
  23. U.S. Food and Drug Administration. FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). Drug Safety Communication. 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-problems-high-doses-allergy-medicine-diphenhydramine-benadryl
  24. Jo YI, Song JO, Park JH, et al. Risk factors for rhabdomyolysis following doxylamine overdose. Human & Experimental Toxicology. 2007. https://doi.org/10.1177/0960327107077507
  25. McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology. 1994. https://doi.org/10.1002/tera.1420500105
  26. Etwel F, Faught LH, Rieder MJ, Koren G. The Risk of Adverse Pregnancy Outcome After First Trimester Exposure to H1 Antihistamines: A Systematic Review and Meta-Analysis. Drug Safety. 2017. https://doi.org/10.1007/s40264-016-0479-9
  27. U.S. Food and Drug Administration. DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, prescribing information. 2025. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bde08f6-e8bd-4e90-baa7-82e01876a86a

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