Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: A randomized controlled trial

Indian Journal of Pharmacology

Volumn 45, Issue 1, 2013, Pages 34-39

  Maroo, Niteeka ^a   Hazra, Avijit ^a   Das, Tapas ^b  

^a INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH   (India)

^b MEDICAL COLLEGE AND HOSPITAL   (India)

Author keywords

Humulus lupulus; insomnia; Passiflora incarnata; Valeriana officinalis; zolpidem

Indexed keywords

HUMULUS LUPULUS EXTRACT; HYPNOTIC SEDATIVE AGENT; NSF 3; PASSIFLORA INCARNATA EXTRACT; PLANT EXTRACT; UNCLASSIFIED DRUG; VALERIAN; ZOLPIDEM;

ADULT; AGED; AMNESIA; AROUSAL; ARTICLE; BEDTIME DOSAGE; CONSTIPATION; CONTROLLED STUDY; DAYTIME SOMNOLENCE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; EPIGASTRIC PAIN; FEMALE; HEADACHE; HUMAN; HUMULUS LUPULUS; INSOMNIA; INSOMNIA SEVERITY INDEX; MAJOR CLINICAL STUDY; MALE; NAUSEA; NONHUMAN; PASSIFLORA; PASSIFLORA INCARNATA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SLEEP QUALITY; SLEEP TIME; SLEEP WALKING; VALERIANA OFFICINALIS;

HUMULUS LUPULUS; INSOMNIA; PASSIFLORA INCARNATA; VALERIANA OFFICINALIS; ZOLPIDEM;

ADULT; AGED; FEMALE; HUMANS; HUMULUS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; PASSIFLORA; PLANT EXTRACTS; PLANTS, MEDICINAL; PYRIDINES; SEVERITY OF ILLNESS INDEX; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TIME FACTORS; TREATMENT OUTCOME; VALERIAN; YOUNG ADULT;

EID: 84874860708     PISSN: 02537613     EISSN: 19983751     Source Type: Journal    
DOI: 10.4103/0253-7613.106432     Document Type: Article

References (30)

1. Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care 2006;12:S214-20.
2. Pigeon WR. Diagnosis, prevalence, pathways, consequences and treatment of insomnia. Indian J Med Res 2010;131:321-32.
3. Szentkirályi A, Madarász CZ, Novák M. Sleep disorders: Impact on daytime functioning and quality of life. ExpertRev Pharmacoecon Outcomes Res 2009;9:49-64.
4. Gooneratne N. Complementary and alternative medicine for sleep disturbances in older adults. Clin Geriatr Med 2008;24:121-38.
5. Approved fi xed combinations. In: Blumenthal M, editor. The complete German Commission E monographs. Therapeutic guide to herbal medicine. Austin, Texas: American Botanical Council Austin;1998. p. 245-306.
6. Coleta M, Batista MT, Campos MG, Carvalho R, Cotrim MD, Lima TC, et al. Neuropharmacological evaluation of the putative anxiolytic effects of Passifl ora edulis Sims, its sub-fractions and flavonoid constituents. Phytother Res 2006;20:1067-73.
7. Ichimura T, Yamanaka A, Ichiba T, Toyokawa T, Kamada Y, Tamamura T, et al. Antihypersensitive effect of an extract of Passifl ora edulis Rind in spontaneously hypersensitive rat. Biosci Biotechnol Biochem 2006;70:718-21.
8. Ngan A, Conduit R. A double-blind, placebo-controlled investigation of the effects of Passifl ora incarnata (passion fl ower) herbal tea on subjective sleep quality. Phytother Res 2011;25:1153-9.
9. Dhawan K, Dhawan S, Sharma A. Passifl ora: A review update. J Ethnopharmacol 2004;94:1-23.
10. Zanoli P, Zavatti M. Pharmacognostic and pharmacological profi le of Humulus lupulus L. J Ethnopharmacol 2008;116:383-96.
11. Lee YJ. Overview of the therapeutic management of insomnia with zolpidem. CNS Drugs 2004;18:17-23.
12. Victorri-Vigneau C, Dailly E, Veyrac G, Jolliet P. Evidence of zolpidem abuse and dependence: Results of the French Centre for Evaluation and Information on Pharmacodependence (CEIP) network survey. Br J Clin Pharmacol 2007;64: 198-209.
13. American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM IV). Washington, DC: American Psychiatric Association;1994.
14. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2001;2:297-307.
15. Johns MW. A new method for measuring daytime sleepiness: The Epworth sleepiness scale. Sleep 1991;14:540-5.
16. Wähling C, Wegener T, Tschaikin M. Triple herbal combination: An effective alternative to benzodiazepines. Z Phytother 2009;30:69-72.
17. Staiger C, Wegener T. Three plant combination for treating sleep disorders and restlessness. Z Phytother 2006;27:12-5.
18. Fernández-San-Martín MI, Masa-Font R, Palacios-Soler L, Sancho-Gómez P, Calbó-Caldentey C, Flores-Mateo G. Effectiveness of Valerian on insomnia: A meta-analysis of randomized placebo-controlled trials. Sleep Med 2010;11:505-11.
19. Dimpfel W, Suter A. Sleep improving effects of a single dose administration of a valerian/hops fl uid extract-a double blind, randomized, placebo-controlled sleep-EEG study in a parallel design using electrohypnograms. Eur J Med Res 2008;13:200-4.
20. Taibi DM, Landis CA, Petry H, Vitiello MV.A systematic review of valerian as a sleep aid: Safe but not effective. Sleep Med Rev 2007;11:209-30.
21. Bent S, Padula A, Moore D, Patterson M, Mehling W. Valerian for sleep: Asystematic review and meta-analysis. Am J Med 2006;119:1005-12.
22. Stevinson C, Ernst E. Valerian for insomnia: Asystematic review of randomized clinical trials. Sleep Med 2000;1:91-9.
23. Koetter U, Schrader E, Käufeler R, Brattström A. A randomized, double blind, placebo-controlled, prospective clinical study to demonstrate clinical effi cacy of a fi xed valerian-hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder. Phytother Res 2007;21:847-51.
24. Akhondzadeh S, Naghavi HR, Vazirian M, Shayeganpour A, Rashidi H, Khani M. Passion fl ower in the treatment of generalized anxiety: A pilot double-blind randomized controlled trial with oxazepam. J Clin Pharm Ther 2001;26:363-7.
25. Trauner G, Khom S, Baburin I, Benedek B, Hering S, Kopp B. Modulation of GABAA receptors by valerian extracts is related to the content of valerinic acid. Planta Med 2008;74:19-24.
26. Schellenberg R, Sauer S, Abouraashed EA, Koetter U, Brattstrom A. The fixed dose combination of valerian and hops (Ze 91019) acts via a central adenosine mechanism. Planta Med 2004;70:594-7.
27. Dietz BM, Mahady GB, Pauli GF, Farnsworth NR. Valerian extracts and valerinic acid are partial agonist of the 5-HT5a receptor in vitro. Brain Res Mol Brain Res 2005;138:191-7.
28. Nassiri-Asl M, Zamansoltani F, Shariati-Rad S. Possible role of GABAA-benzodiazepine receptor in anticonvulsant effects of Pasipay in rats. Zhong Xi Yi Jie He XueBao 2008;6:1170-3.
29. Butterweck V, Brattstroem A, Grundman O, Koetter U. Hypothermic effects of melatonin receptor are antagonised with the comparative melatonin receptor antagonist luzindole in mice. J Pharm Pharmacol 2007;59:549-52.
30. Rosekind MR, Gregory KB. Insomnia risks and costs: Health, safety, and quality of life. Am J Manag Care 2010;16:617-2.