Efficacy and Safety of the Herbal Medicine Sominex ® (Passiflora Incarnata L., Valeriana Officinalis L. and Crataegus Oxyacantha L.), Manufactured by the Laboratory EMS S / A in Patients With Psychophysiological Insomnia

The main objective of this study is to evaluate the clinical efficacy of the drug Sominex (Valeriana officinalis L., 40 mg, 30 mg Crataegus oxyacantha L. and Passiflora incarnata L. 50 mg) manufactured by the Laboratory EMS S / A, compared to placebo in improving sleep efficiency, based on the response of the sleep quality questionnaire (MSQ) and polysomnographic parameters described below:
Latency to onset of sleep;
Total time of sleep;
Rapid eye movement (REM) sleep latency;
Duration of REM sleep

Start Date01 Oct 2010

Sponsor / Collaborator

Azidus Brasil

100 Clinical Results associated with Sominex

100 Translational Medicine associated with Sominex

100 Patents (Medical) associated with Sominex

Literatures (Medical) associated with Sominex

01 Aug 1985·The Canadian Journal of PsychiatryQ3 · MEDICINE

Tardive Dyskinesia Uncovered After Ingestion of Sominex, an Over-the-Counter Drug

Q3 · MEDICINE

Article

Author: Jones, B. ; Lal, S.

Ingestion of an over-the-counter preparation of diphenhydramine (Sominex®), an anticholinergic antihistamine, induced a dramatic uncovering of generalized tardive dyskinesia in an outpatient on chronic neuroleptic therapy. Failure to obtain a detailed medication history, including that of non-prescription drugs, may lead to incorrect diagnosis and management.

01 Mar 1979·Journal of the American College of Emergency Physicians

Acute poisoning from over-the-counter sleep preparations

Article

Author: Barry H. Rumack ; Christopher S. Conner ; Rebecca G. Hooper

All cases received by the Rocky Mountain Poison Center involving over-the-counter (OTC) sleep preparations were studied during an 18-month period to elucidate 1) the range of toxicity; 2) characteristic symptoms, and 3) the time of onset of symptoms. In 155 cases reviewed retrospectively, the three most commonly ingested agents were Sominex, Nytol and Sleepeze. Multiple ingestions were also involved. Symptomatology was equally divided among no symptoms, mild symptoms and possible life-threatening symptoms. The least amount taken to produce possible life-threatening symptoms was 16 Sominex, 18 Nytol and 15 Sleepeze, although the average amount producing the same symptoms was approximately twice that. These symptoms were seen within six hours in all but three of the 39 cases presenting with these symptoms. There were no deaths.

01 Jan 1979·Clinical Toxicology

Self-Poisoning with Over-the-Counter Hypnotics

Article

Author: Barbara J. Noel ; Marcia Divoll Allen ; David J. Greenblatt

Over-the-counter (OTC) hypnotic preparations (such as Sominex, Nytol, and Sleep Eze) were implicated in 21 of the 773 admissions to Massachusetts General Hospital due to psychotropic drug overdosage between 1962 and 1975. Ten of the 21 cases had manifestations of central anticholinergic toxicity ("atropine-like psychosis"), such as hallucinations, delirium, and confusion. However, all patients recovered rapidly and without sequelae. Specific therapy (i.e., physostigmine) was rarely required. Thus OTC hypnotic overdosage commonly produces "toxic psychosis." Fortunately, intoxication is usually of short duration and relatively benign.

100 Deals associated with Sominex

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	Phase 3	Brazil	Azidus Brasil	01 Oct 2010

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