diphenhydramine has been researched along with Sleep Initiation and Maintenance Disorders in 42 studies
Diphenhydramine: A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
diphenhydramine : An ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug.
antitussive : An agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration.
Sleep Initiation and Maintenance Disorders: Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To determine whether the commonly used over-the-counter medications dextromethorphan and diphenhydramine are superior to placebo for the treatment of nocturnal cough and sleep difficulty associated with upper respiratory infections and to determine whether parents have improved sleep quality when their children receive the medications when compared with placebo." | 9.11 | Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. ( Berlin, CM; Carlson, LC; Crowell, KR; Dilworth, DA; McMillan, HS; Paul, IM; Shaffer, ML; Yoder, KE, 2004) |
| "To determine whether the commonly used over-the-counter medications dextromethorphan and diphenhydramine are superior to placebo for the treatment of nocturnal cough and sleep difficulty associated with upper respiratory infections and to determine whether parents have improved sleep quality when their children receive the medications when compared with placebo." | 5.11 | Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. ( Berlin, CM; Carlson, LC; Crowell, KR; Dilworth, DA; McMillan, HS; Paul, IM; Shaffer, ML; Yoder, KE, 2004) |
| " In a safety assessment, the highest incidence of adverse events (48." | 3.30 | [Comparative study of the clinical efficacy and safety of the fixed dose combination Levroso Long with Melaxen and Diphenhydramine in patients with insomnia]. ( Leykin, ZN; Popova, VB, 2023) |
| "Fifty-four pregnant women with insomnia were randomly assigned to trazodone, diphenhydramine, or placebo treatment." | 2.78 | Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial. ( Emamian, F; Ghadami, MR; Khazaie, H; Knight, DC; Tahmasian, M, 2013) |
| "Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs." | 2.71 | Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial. ( Bastien, C; Koetter, U; Morin, CM; Ware, JC; Wooten, V, 2005) |
| "Physicians' global evaluation of insomnia demonstrated no changes in the pre-drug placebo period, moderate improvement under both drugs, with a marginal advantage of SOM over LOR in the first 2 weeks, and a return to pre-drug values in the post-drug placebo period." | 2.68 | Nonorganic insomnia in generalized anxiety disorder. 2. Comparative studies on sleep, awakening, daytime vigilance and anxiety under lorazepam plus diphenhydramine (Somnium) versus lorazepam alone, utilizing clinical, polysomnographic and EEG mapping meth ( Anderer, P; Brandstätter, N; Frey, R; Gruber, G; Grünberger, J; Klösch, G; Linzmayer, L; Mandl, M; Saletu, B; Saletu-Zyhlarz, G, 1997) |
| " Diphenhydramine hydrochloride thus appears to be effective in the treatment of insomnia, but the appropriate dosage will depend on previous medical treatment of insomnia." | 2.67 | Clinical evaluation of diphenhydramine hydrochloride for the treatment of insomnia in psychiatric patients: a double-blind study. ( Kudo, Y; Kurihara, M, 1990) |
| "Thirty patients complaining of insomnia were studied in a double-blind trial with crossover of Finorgal, nitrazepam and triclofos sodium." | 2.65 | Comparative trial of a new hypnotic (Finorgal) with nitrazepam and triclofos sodium. ( Baiotti, G, 1979) |
| "Up to 40% of older adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking." | 2.47 | Insomnia (primary) in older people. ( Alessi, C; Vitiello, MV, 2011) |
| " Other agents commonly used at sea-level such as eszopiclone and diphenhydramine have not been studied at high altitude but are likely safe to use given their mechanism of action and known side effects." | 2.44 | Which medications are safe and effective for improving sleep at high altitude? ( Luks, AM, 2008) |
| "Insomnia is one of the most common minor ailments to which patients seek advice in a community pharmacy setting." | 1.51 | Assessing insomnia management in community pharmacy setting in Jordan: A simulated patient approach. ( Elayeh, E; Hammad, EA; Tubeileh, R; Wazaify, M, 2019) |
| "It explains the origin and course of insomnia on the basis of interaction of three factors: predisposing, precipitating and perpetuating." | 1.42 | [Chronic insomnia: treatment methods based on the current "3P" model of insomnia]. ( Pchelina, PV; Poluektov, MG, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 21 (50.00) | 18.7374 |
| 1990's | 4 (9.52) | 18.2507 |
| 2000's | 8 (19.05) | 29.6817 |
| 2010's | 8 (19.05) | 24.3611 |
| 2020's | 1 (2.38) | 2.80 |
| Authors | Studies |
|---|---|
| Popova, VB | 1 |
| Leykin, ZN | 1 |
| Wazaify, M | 1 |
| Elayeh, E | 1 |
| Tubeileh, R | 1 |
| Hammad, EA | 1 |
| Dahl, T | 1 |
| Chen, LB | 1 |
| Zammit, G | 1 |
| Ahmad, M | 1 |
| Roth, T | 3 |
| Khazaie, H | 1 |
| Ghadami, MR | 1 |
| Knight, DC | 1 |
| Emamian, F | 1 |
| Tahmasian, M | 1 |
| Cooper, S | 1 |
| Laurora, I | 1 |
| Wang, Y | 1 |
| Venkataraman, P | 1 |
| An, R | 1 |
| Poluektov, MG | 1 |
| Pchelina, PV | 1 |
| Luks, AM | 1 |
| Zhang, D | 1 |
| Tashiro, M | 1 |
| Shibuya, K | 1 |
| Okamura, N | 1 |
| Funaki, Y | 1 |
| Yoshikawa, T | 1 |
| Kato, M | 1 |
| Yanai, K | 1 |
| Lucey, BP | 1 |
| Noetzel, MJ | 1 |
| Duntley, SP | 1 |
| Alessi, C | 1 |
| Vitiello, MV | 1 |
| JONES, DP | 1 |
| JONES, EA | 1 |
| Paul, IM | 1 |
| Yoder, KE | 1 |
| Crowell, KR | 1 |
| Shaffer, ML | 1 |
| McMillan, HS | 1 |
| Carlson, LC | 1 |
| Dilworth, DA | 1 |
| Berlin, CM | 1 |
| Morin, CM | 1 |
| Koetter, U | 1 |
| Bastien, C | 1 |
| Ware, JC | 1 |
| Wooten, V | 1 |
| Terao, A | 1 |
| Miyamoto, M | 1 |
| Glass, JR | 1 |
| Sproule, BA | 1 |
| Herrmann, N | 1 |
| Busto, UE | 1 |
| O'Connor, CA | 1 |
| Brodbin, P | 1 |
| Guthrie, SK | 1 |
| Sung, JC | 1 |
| Goodson, J | 1 |
| Grunhaus, L | 1 |
| Tandon, R | 1 |
| Saletu, B | 2 |
| Saletu-Zyhlarz, G | 2 |
| Anderer, P | 1 |
| Brandstätter, N | 1 |
| Frey, R | 2 |
| Gruber, G | 1 |
| Klösch, G | 1 |
| Mandl, M | 1 |
| Grünberger, J | 2 |
| Linzmayer, L | 2 |
| Böck, G | 1 |
| Weissgram, S | 1 |
| Brandstaätter, N | 1 |
| Roehrs, T | 1 |
| Turner, L | 1 |
| Rooke, KC | 1 |
| Hartmann, E | 1 |
| Baiotti, G | 2 |
| Kudo, Y | 1 |
| Kurihara, M | 1 |
| Meuleman, JR | 1 |
| Nelson, RC | 1 |
| Clark, RL | 1 |
| Haider, I | 1 |
| Tétreault, L | 1 |
| Bordeleau, JM | 1 |
| Johns, MW | 1 |
| Hepburn, M | 1 |
| Goodyear, MD | 1 |
| Guz, I | 2 |
| Segre, CD | 1 |
| Ribas, JC | 2 |
| de Sena, PG | 2 |
| Rizzo, Ade O | 1 |
| de Fortes, JR | 1 |
| Orlandi, OV | 1 |
| Fraga Filho, C | 1 |
| Toledo, JA | 1 |
| Mello, Ode O | 1 |
| Weiss, LR | 1 |
| Marsiaj, B | 1 |
| Kammerer, T | 1 |
| Singer, L | 1 |
| Patris, M | 1 |
| Roos, AM | 1 |
| Shapiro, S | 1 |
| Slone, D | 1 |
| Lewis, GP | 1 |
| Jick, H | 1 |
| Tharp, BR | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Term Insomnia[NCT02671760] | Phase 2 | 39 participants (Actual) | Interventional | 2016-02-29 | Completed | ||
| [NCT05753943] | 0 participants | Expanded Access | No longer available | ||||
| A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep[NCT01280591] | Phase 3 | 712 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep[NCT01495858] | Phase 3 | 267 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| Treatment of High-altitude Sleep Disturbance: A Double-blind Comparison of Temazepam Versus Acetazolamide.[NCT01519544] | 34 participants (Actual) | Interventional | 2012-03-31 | Completed | |||
| Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors[NCT02444026] | 225 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting | |||
| Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold[NCT02486835] | 150 participants (Actual) | Interventional | 2015-12-23 | Completed | |||
| Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)[NCT01814293] | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn (stopped due to loss of funding. No data was collected.) | |||
| A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection[NCT03218696] | 80 participants (Anticipated) | Interventional | 2018-02-28 | Not yet recruiting | |||
| Randomized, Single Blind, Multicenter Study to Evaluate the Efficacy and Tolerability of Syr. Grintuss Pediatric and Syr. Mucolit in Cough Due to Upper Respiratory Tract Infection in Children[NCT01968434] | Phase 4 | 150 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Safety and tolerability assessed in terms of the incidence of AEs (NCT02671760)
Timeframe: 8 hours
| Intervention | Number of Events (Number) |
|---|---|
| Treatment | 2 |
| Comparator | 3 |
| Placebo | 2 |
(NCT02671760)
Timeframe: 8 hours
| Intervention | Awakenings (Mean) |
|---|---|
| Treatment | 12.2 |
| Comparator | 11.0 |
| Placebo | 9.6 |
Time it takes to fall asleep (NCT02671760)
Timeframe: 8 hours
| Intervention | minutes (Mean) |
|---|---|
| Treatment | 31.2 |
| Comparator | 42.1 |
| Placebo | 50.1 |
Time required to achieve REM sleep (NCT02671760)
Timeframe: 8 hours
| Intervention | minutes (Mean) |
|---|---|
| Treatment | 112.5 |
| Comparator | 71.3 |
| Placebo | 61.2 |
Digit Symbol Substitution Test. The test score is number of correct answers in 90 seconds. Higher scores indicate favorable response (i.e., less residual sleepiness). The duration of the challenge is the 90 second time limit; there is no theoretical maximum score to attain. (NCT02671760)
Timeframe: 8 hours
| Intervention | Correct answers (Mean) |
|---|---|
| Treatment | 53.1 |
| Comparator | 53.3 |
| Placebo | 55.3 |
Karolinska Sleepiness Scale. This is a 9-point scale with values ranging from 1 (extremely alert) to 9 (extremely sleepy). Lower scores indicate less residual sleepiness. (NCT02671760)
Timeframe: 8 hours
| Intervention | Units on a scale (Mean) |
|---|---|
| Treatment | 5.8 |
| Comparator | 6.0 |
| Placebo | 6.1 |
(NCT02671760)
Timeframe: 8 hours
| Intervention | minutes (Mean) |
|---|---|
| Treatment | 382.9 |
| Comparator | 339.2 |
| Placebo | 256.2 |
Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01280591)
Timeframe: Baseline and up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | -1.2 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | -0.7 |
| Naproxen Sodium 440 mg (BAYH6689) | -0.9 |
| DPH 50 mg | 0.1 |
Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Percent of sleep time during in-bed time (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 71.0 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 56.3 |
| Naproxen Sodium 440 mg (BAYH6689) | 59.3 |
| DPH 50 mg | 23.6 |
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Median) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 25.50 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 30.25 |
| Naproxen Sodium 440 mg (BAYH6689) | 25.75 |
| DPH 50 mg | 41.50 |
Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 73.8 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 75.3 |
| Naproxen Sodium 440 mg (BAYH6689) | 103.5 |
| DPH 50 mg | 81.7 |
Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 6.4 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 5.9 |
| Naproxen Sodium 440 mg (BAYH6689) | 5.4 |
| DPH 50 mg | 4.9 |
Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 6.2 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 5.8 |
| Naproxen Sodium 440 mg (BAYH6689) | 5.5 |
| DPH 50 mg | 4.4 |
Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 40.0 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 40.7 |
| Naproxen Sodium 440 mg (BAYH6689) | 53.4 |
| DPH 50 mg | 42.4 |
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Median) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | NA |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | NA |
| Naproxen Sodium 440 mg (BAYH6689) | NA |
| DPH 50 mg | 113.5 |
Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 426.2 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 337.7 |
| Naproxen Sodium 440 mg (BAYH6689) | 355.8 |
| DPH 50 mg | 141.4 |
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 143.7 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 230.9 |
| Naproxen Sodium 440 mg (BAYH6689) | 214.0 |
| DPH 50 mg | 431.4 |
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ≤ 60 minutes | ≤ 120 minutes | ≤ 180 minutes | ≤ 240 minutes | ≤ 300 minutes | ≤ 360 minutes | ≤ 420 minutes | ≤ 480 minutes | ≤ 540 minutes | ≤ 600 minutes | |
| DPH 50 mg | 0 | 53 | 66 | 70 | 74 | 76 | 77 | 78 | 78 | 78 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 1 | 36 | 50 | 57 | 65 | 69 | 78 | 83 | 87 | 89 |
| Naproxen Sodium 440 mg (BAYH6689) | 0 | 27 | 41 | 47 | 50 | 55 | 62 | 63 | 67 | 68 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 0 | 18 | 23 | 25 | 29 | 34 | 36 | 39 | 42 | 43 |
The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = Poor | 1 = Fair | 2 = Good | 3 = Very good | 4 = Excellent | |
| DPH 50 mg | 4 | 5 | 9 | 7 | 0 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 2 | 16 | 35 | 48 | 25 |
| Naproxen Sodium 440 mg (BAYH6689) | 0 | 15 | 36 | 56 | 34 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 2 | 9 | 43 | 64 | 48 |
The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = Poor | 1 = Fair | 2 = Good | 3 = Very good | 4 = Excellent | |
| DPH 50 mg | 3 | 9 | 6 | 7 | 0 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 10 | 29 | 47 | 26 | 13 |
| Naproxen Sodium 440 mg (BAYH6689) | 29 | 51 | 37 | 17 | 7 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 8 | 39 | 58 | 49 | 12 |
Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very restless | 2 = Rather restless | 3 = Neither restless nor calm | 4 = Rather calm | 5 = Very calm | |
| DPH 50 mg | 5 | 16 | 10 | 12 | 3 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 8 | 29 | 39 | 68 | 26 |
| Naproxen Sodium 440 mg (BAYH6689) | 7 | 48 | 42 | 61 | 22 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 8 | 35 | 37 | 76 | 32 |
Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very difficult | 2 = Rather difficult | 3 = Neither difficult nor easy | 4 = Rather easy | 5 = Very easy | |
| DPH 50 mg | 0 | 1 | 10 | 15 | 20 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 0 | 4 | 24 | 94 | 48 |
| Naproxen Sodium 440 mg (BAYH6689) | 1 | 2 | 33 | 88 | 56 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 0 | 7 | 28 | 98 | 55 |
Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very difficult | 2 = Rather difficult | 3 = Neither difficult nor easy | 4 = Rather easy | 5 = Very easy | |
| DPH 50 mg | 8 | 16 | 10 | 9 | 3 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 11 | 45 | 57 | 42 | 15 |
| Naproxen Sodium 440 mg (BAYH6689) | 12 | 59 | 55 | 41 | 13 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 8 | 41 | 57 | 62 | 20 |
Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||
|---|---|---|---|
| 1 = Woke up much too early | 2 = Woke up somewhat too early | 3 = No | |
| DPH 50 mg | 23 | 17 | 6 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 54 | 59 | 57 |
| Naproxen Sodium 440 mg (BAYH6689) | 65 | 80 | 35 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 40 | 77 | 71 |
Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very poor | 2 = Rather poor | 3 = Neither poor nor good | 4 = Rather good | 5 = Very good | |
| DPH 50 mg | 3 | 10 | 13 | 18 | 2 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 5 | 24 | 52 | 68 | 21 |
| Naproxen Sodium 440 mg (BAYH6689) | 5 | 39 | 69 | 55 | 12 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 3 | 23 | 46 | 82 | 34 |
Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = No, definitely too little | 2 = No, much too little | 3 = No, somewhat too little | 4 = Yes, almost enough | 5 = Yes, definitely enough | |
| DPH 50 mg | 10 | 8 | 14 | 9 | 5 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 21 | 24 | 40 | 52 | 33 |
| Naproxen Sodium 440 mg (BAYH6689) | 18 | 22 | 56 | 58 | 26 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 7 | 14 | 37 | 84 | 46 |
Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||
|---|---|---|---|
| 1 = Not rested at all | 2 = Somewhat unrested | 3 = Completely rested | |
| DPH 50 mg | 8 | 31 | 7 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 21 | 95 | 54 |
| Naproxen Sodium 440 mg (BAYH6689) | 16 | 116 | 48 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 9 | 100 | 79 |
"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01280591)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = No relief | 1 = A little relief | 2 = Some relief | 3 = A lot of relief | 4 = Complete relief | |
| DPH 50 mg | 79 | 1 | 11 | 8 | 3 |
| Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111) | 89 | 4 | 29 | 53 | 29 |
| Naproxen Sodium 440 mg (BAYH6689) | 68 | 8 | 24 | 62 | 40 |
| Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111) | 44 | 4 | 32 | 65 | 58 |
Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01495858)
Timeframe: Baseline and up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 2.4 |
| Naproxen Sodium 440 mg (BAYH6689) | 2.4 |
| DPH 50 mg | 2.5 |
Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Percent of sleep time during in-bed time (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 69.777 |
| Naproxen Sodium 440 mg (BAYH6689) | 65.396 |
| DPH 50 mg | 34.436 |
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Median) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 23.50 |
| Naproxen Sodium 440 mg (BAYH6689) | 16.75 |
| DPH 50 mg | 27.50 |
Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 111.1 |
| Naproxen Sodium 440 mg (BAYH6689) | 144.8 |
| DPH 50 mg | 98.4 |
Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent. (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 6.5 |
| Naproxen Sodium 440 mg (BAYH6689) | 5.8 |
| DPH 50 mg | 4.9 |
Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Scores on a scale (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 6.6 |
| Naproxen Sodium 440 mg (BAYH6689) | 5.7 |
| DPH 50 mg | 4.6 |
Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 39.5 |
| Naproxen Sodium 440 mg (BAYH6689) | 40.2 |
| DPH 50 mg | 40.0 |
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Median) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | NA |
| Naproxen Sodium 440 mg (BAYH6689) | NA |
| DPH 50 mg | 146.50 |
Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 418.66 |
| Naproxen Sodium 440 mg (BAYH6689) | 392.38 |
| DPH 50 mg | 206.61 |
(NCT01495858)
Timeframe: Baseline and Day 2
| Intervention | mmHg (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 0.7 |
| Naproxen Sodium 440 mg (BAYH6689) | -0.2 |
| DPH 50 mg | 2.1 |
(NCT01495858)
Timeframe: Baseline and day 2
| Intervention | Beats/min (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 1.0 |
| Naproxen Sodium 440 mg (BAYH6689) | -0.1 |
| DPH 50 mg | 4.7 |
(NCT01495858)
Timeframe: Baseline and day 2
| Intervention | Breaths/min (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | -1.4 |
| Naproxen Sodium 440 mg (BAYH6689) | -1.2 |
| DPH 50 mg | -0.3 |
(NCT01495858)
Timeframe: Baseline and day 2
| Intervention | mmHg (Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | -1.3 |
| Naproxen Sodium 440 mg (BAYH6689) | -0.6 |
| DPH 50 mg | 2.2 |
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 155.25 |
| Naproxen Sodium 440 mg (BAYH6689) | 180.08 |
| DPH 50 mg | 364.83 |
If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ≤ 60 minutes | ≤ 120 minutes | ≤ 180 minutes | ≤ 240 minutes | ≤ 300 minutes | ≤ 360 minutes | ≤ 420 minutes | ≤ 480 minutes | ≤ 540 minutes | ≤ 600 minutes | |
| DPH 50 mg | 0 | 21 | 29 | 32 | 33 | 34 | 35 | 35 | 35 | 35 |
| Naproxen Sodium 440 mg (BAYH6689) | 1 | 12 | 13 | 17 | 23 | 25 | 26 | 28 | 30 | 30 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 0 | 9 | 14 | 15 | 16 | 17 | 21 | 22 | 24 | 24 |
The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = Poor | 1 = Fair | 2 = Good | 3 = Very good | 4 = Excellent | |
| DPH 50 mg | 1 | 5 | 3 | 9 | 1 |
| Naproxen Sodium 440 mg (BAYH6689) | 1 | 3 | 25 | 38 | 12 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 1 | 4 | 22 | 40 | 18 |
The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = Poor | 1 = Fair | 2 = Good | 3 = Very good | 4 = Excellent | |
| DPH 50 mg | 1 | 7 | 2 | 8 | 1 |
| Naproxen Sodium 440 mg (BAYH6689) | 13 | 24 | 24 | 13 | 5 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 2 | 12 | 37 | 23 | 11 |
Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very restless | 2 = Rather restless | 3 = Neither restless nor calm | 4 = Rather calm | 5 = Very calm | |
| DPH 50 mg | 5 | 17 | 5 | 13 | 4 |
| Naproxen Sodium 440 mg (BAYH6689) | 3 | 29 | 24 | 42 | 4 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 1 | 26 | 18 | 48 | 9 |
Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very difficult | 2 = Rather difficult | 3 = Neither difficult nor easy | 4 = Rather easy | 5 = Very easy | |
| DPH 50 mg | 0 | 2 | 5 | 14 | 23 |
| Naproxen Sodium 440 mg (BAYH6689) | 3 | 0 | 16 | 53 | 30 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 0 | 1 | 17 | 56 | 28 |
Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very difficult | 2 = Rather difficult | 3 = Neither difficult nor easy | 4 = Rather easy | 5 = Very easy | |
| DPH 50 mg | 9 | 6 | 14 | 12 | 3 |
| Naproxen Sodium 440 mg (BAYH6689) | 8 | 33 | 27 | 23 | 11 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 3 | 29 | 22 | 36 | 12 |
Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||
|---|---|---|---|
| 1 = Woke up much too early | 2 = Woke up somewhat too early | 3 = No | |
| DPH 50 mg | 21 | 11 | 12 |
| Naproxen Sodium 440 mg (BAYH6689) | 31 | 52 | 19 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 24 | 45 | 33 |
Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = Very poor | 2 = Rather poor | 3 = Neither poor nor good | 4 = Rather good | 5 = Very good | |
| DPH 50 mg | 9 | 11 | 9 | 12 | 3 |
| Naproxen Sodium 440 mg (BAYH6689) | 3 | 22 | 31 | 36 | 10 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 1 | 12 | 33 | 47 | 9 |
Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 1 = No, definitely too little | 2 = No, much too little | 3 = No, somewhat too little | 4 = Yes, almost enough | 5 = Yes, definitely enough | |
| DPH 50 mg | 13 | 6 | 8 | 11 | 6 |
| Naproxen Sodium 440 mg (BAYH6689) | 10 | 10 | 27 | 34 | 21 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 2 | 8 | 18 | 52 | 22 |
Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||
|---|---|---|---|
| 1 = Not rested at all | 2 = Somewhat unrested | 3 = Completely rested | |
| DPH 50 mg | 13 | 17 | 14 |
| Naproxen Sodium 440 mg (BAYH6689) | 9 | 55 | 38 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 7 | 53 | 42 |
"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01495858)
Timeframe: Up to 10 hours
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| 0 = No relief | 1 = A little relief | 2 = Some relief | 3 = A lot of relief | 4 = Complete relief | |
| DPH 50 mg | 35 | 4 | 5 | 8 | 2 |
| Naproxen Sodium 440 mg (BAYH6689) | 30 | 3 | 15 | 37 | 21 |
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | 24 | 5 | 10 | 47 | 21 |
"A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as change in combined day cough score and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient." (NCT01968434)
Timeframe: 4 nights (onset of trial Night 1 to Night 4) and 3 days
| Intervention | change in combined day cough score (Mean) |
|---|---|
| Protective Cough Syrup | -6.17 |
| Carbocisteine Cough Syrup | -4.54 |
"A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient." (NCT01968434)
Timeframe: 4 nights (onset of trial Night 1 to Night 4) and 3 days
| Intervention | change in combined night cough score (Mean) |
|---|---|
| Protective Cough Syrup | -13.92 |
| Carbocisteine Cough Syrup | -9.48 |
"Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient." (NCT01968434)
Timeframe: 1 night from before enrollment (N0) to first night after treatment (N1)
| Intervention | change in combined night cough score (Mean) |
|---|---|
| Protective Cough Syrup | -5.16 |
| Carbocisteine Cough Syrup | -1.77 |
3 reviews available for diphenhydramine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Which medications are safe and effective for improving sleep at high altitude?
Topics: Acetamides; Acetazolamide; Altitude Sickness; Anti-Anxiety Agents; Azabicyclo Compounds; Benzodiazep | 2008 |
Insomnia (primary) in older people.
Topics: Cognitive Behavioral Therapy; Diphenhydramine; Evidence-Based Medicine; Humans; Prevalence; Sleep; S | 2011 |
[Recent and potential drugs for treatment of insomnia].
Topics: Animals; Azabicyclo Compounds; Benzodiazepines; Diphenhydramine; Drug Design; Fluorobenzenes; GABA-A | 2007 |
19 trials available for diphenhydramine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
[Comparative study of the clinical efficacy and safety of the fixed dose combination Levroso Long with Melaxen and Diphenhydramine in patients with insomnia].
Topics: Diphenhydramine; Humans; Melatonin; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Out | 2023 |
Efficacy of SM-1 in a transient insomnia model.
Topics: Adult; Cross-Over Studies; Diphenhydramine; Double-Blind Method; Drug Combinations; Female; Humans; | 2019 |
Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial.
Topics: Actigraphy; Adult; Antidepressive Agents, Second-Generation; Depression; Depression, Postpartum; Dip | 2013 |
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.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B | 2015 |
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.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B | 2015 |
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.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B | 2015 |
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.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B | 2015 |
Next-day residual sedative effect after nighttime administration of an over-the-counter antihistamine sleep aid, diphenhydramine, measured by positron emission tomography.
Topics: Administration, Oral; Brain; Cross-Over Studies; Diphenhydramine; Double-Blind Method; Histamine H1 | 2010 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; D | 2004 |
Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial.
Topics: Adult; Aged; Diphenhydramine; Female; Humans; Humulus; Hypnotics and Sedatives; Male; Middle Aged; P | 2005 |
Effects of 2-week treatment with temazepam and diphenhydramine in elderly insomniacs: a randomized, placebo-controlled trial.
Topics: Aged; Aged, 80 and over; Cross-Over Studies; Diphenhydramine; Dizziness; Dose-Response Relationship, | 2008 |
A double-blind trial of the new hypnotic, 'mandrax'.
Topics: Adult; Aged; Amobarbital; Diphenhydramine; Humans; Methaqualone; Middle Aged; Sleep Initiation and M | 1967 |
Triazolam and diphenhydramine effects on seizure duration in depressed patients receiving ECT.
Topics: Adult; Aged; Depressive Disorder; Diphenhydramine; Electroconvulsive Therapy; Electroencephalography | 1996 |
Nonorganic insomnia in generalized anxiety disorder. 2. Comparative studies on sleep, awakening, daytime vigilance and anxiety under lorazepam plus diphenhydramine (Somnium) versus lorazepam alone, utilizing clinical, polysomnographic and EEG mapping meth
Topics: Adult; Aged; Anti-Anxiety Agents; Anxiety Disorders; Arousal; Attention; Brain Mapping; Cerebral Cor | 1997 |
Comparative studies on the effects of the combination drug lorazepam plus diphenhydramine (Somnium) versus lorazepam on the noopsyche, thymopsyche and psychophysiology in nonorganic insomnia related to generalized anxiety disorder.
Topics: Adult; Aged; Anxiety Disorders; Diphenhydramine; Discriminant Analysis; Double-Blind Method; Drug Co | 1997 |
Effects of sleep loss on waking actigraphy.
Topics: Adult; Diphenhydramine; Female; Humans; Hypnotics and Sedatives; Male; Polysomnography; Sleep Initia | 2000 |
Comparative trial of a new hypnotic (Finorgal) with nitrazepam and triclofos sodium.
Topics: Administration, Oral; Adult; Aged; Capsules; Clinical Trials as Topic; Diphenhydramine; Double-Blind | 1979 |
Comparison of a new hypnotic (Finorgal) with placebo in a double-blind trial.
Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Diphenhydramine; Double-Blind Method; Drug Combin | 1979 |
Clinical evaluation of diphenhydramine hydrochloride for the treatment of insomnia in psychiatric patients: a double-blind study.
Topics: Adolescent; Adult; Aged; Diphenhydramine; Double-Blind Method; Humans; Middle Aged; Remission Induct | 1990 |
Evaluation of temazepam and diphenhydramine as hypnotics in a nursing-home population.
Topics: Aged; Anti-Anxiety Agents; Diphenhydramine; Drug Evaluation; Female; Florida; Humans; Hypnotics and | 1987 |
A comparative trial of mandrax and dichloralphenazone.
Topics: Aged; Antipyrine; Chloral Hydrate; Clinical Trials as Topic; Diphenhydramine; Humans; Mental Disorde | 1968 |
[Comparative evaluation of Mnadrax, secobarbital and placebo in the mental patient: Mandrax tolerance and Mandrax-secobarbital cross tolerance].
Topics: Adolescent; Adult; Analysis of Variance; Clinical Trials as Topic; Diphenhydramine; Drug Tolerance; | 1968 |
20 other studies available for diphenhydramine and Sleep Initiation and Maintenance Disorders
| Article | Year |
|---|---|
Assessing insomnia management in community pharmacy setting in Jordan: A simulated patient approach.
Topics: Acetaminophen; Adult; Community Pharmacy Services; Counseling; Cross-Sectional Studies; Diphenhydram | 2019 |
[Chronic insomnia: treatment methods based on the current "3P" model of insomnia].
Topics: Brain; Cognitive Behavioral Therapy; Diphenhydramine; Disease Susceptibility; Doxylamine; Histamine | 2015 |
Sleep complaints: Whenever possible, avoid the use of sleeping pills.
Topics: Acupuncture Therapy; Adult; Aged; Behavior Therapy; Benzodiazepines; Clinical Trials as Topic; Conge | 2008 |
Paroxysmal arousals and myoclonic movements associated with interictal epileptiform discharges in NREM and REM sleep.
Topics: Adolescent; Amines; Antiparkinson Agents; Arousal; Chromosome Disorders; Chromosome Inversion; Chrom | 2011 |
DRUGS FOR INSOMNIA.
Topics: Amobarbital; Child; Chloral Hydrate; Diphenhydramine; Humans; Paraldehyde; Phenobarbital; Promethazi | 1963 |
More on sleeping pills.
Topics: Azabicyclo Compounds; Diphenhydramine; Drug Administration Schedule; Histamine H1 Antagonists; Human | 2005 |
The use of flurazepam (dalmane) as a substitute for barbiturates and methaqualone/diphenhydramine (mandrax) in general practice.
Topics: Adult; Aged; Anti-Anxiety Agents; Barbiturates; Diphenhydramine; Drug Combinations; Family Practice; | 1976 |
[Drugs against insomnia].
Topics: Barbiturates; Chloral Hydrate; Diphenhydramine; Flurazepam; Glutethimide; Humans; Hypnotics and Seda | 1978 |
Use of hypnotic drugs by hospital patients.
Topics: Adult; Aged; Amobarbital; Antipyrine; Barbiturates; Diphenhydramine; Female; Hospitalization; Humans | 1971 |
[Use of the combination methaqualone-diphenyhydramine in ambulatory patients].
Topics: Adolescent; Adult; Alcoholism; Ambulatory Care; Anxiety; Diphenhydramine; Female; Humans; Male; Meth | 1969 |
[Mandrix in epilepsy].
Topics: Adolescent; Adult; Child; Diphenhydramine; Electroencephalography; Epilepsy; Female; Humans; Male; M | 1969 |
[Therapeutic test with a new non-barbiturate hypnotic].
Topics: Adolescent; Adult; Alcoholism; Diphenhydramine; Humans; Hypnotics and Sedatives; Male; Mental Disord | 1968 |
[Use of a new non-barbiturate hypnotic in children].
Topics: Child, Preschool; Diphenhydramine; Humans; Hypnotics and Sedatives; Infant; Male; Methaqualone; Slee | 1968 |
[1st reports on a new non-barbiturate hypnotic].
Topics: Adolescent; Adult; Diphenhydramine; Female; Humans; Hypnotics and Sedatives; Male; Methaqualone; Mid | 1968 |
[Therapeutic tests on the use of Mandrix in neurotics].
Topics: Adult; Diphenhydramine; Female; Humans; Hypnotics and Sedatives; Male; Methaqualone; Neurotic Disord | 1968 |
[1st tests with a non-barbiturate hypnotic in medical pathology].
Topics: Diphenhydramine; Humans; Methaqualone; Pathology; Sleep Initiation and Maintenance Disorders | 1968 |
[Mandrix in neurologic pathology].
Topics: Adult; Central Nervous System Diseases; Diphenhydramine; Female; Humans; Hypnotics and Sedatives; Ma | 1968 |
[Clinical study of Mandrax].
Topics: Adolescent; Adult; Aged; Diphenhydramine; Drug Synergism; Humans; Methaqualone; Middle Aged; Sleep I | 1969 |
Clinical effects of hypnotics. II. An epidemiologic study.
Topics: Body Weight; Chloral Hydrate; Diphenhydramine; Female; Humans; Hypnotics and Sedatives; Male; Pentob | 1969 |
The 6-per-second spike and wave complex. The wave and spike phantom.
Topics: Adolescent; Adult; Brain; Diphenhydramine; Electroencephalography; Electrophysiology; Humans; Male; | 1966 |