Overview

Why use a natural menopause formula?

More effective than soy
Black cohosh has been proven to be more effective than soy at relieving menopausal symptoms^†

For natural relief and a real alternative.^†
A reliable, clinically-studied black cohosh extract can provide natural relief from hot flashes, night sweats, mood swings.† It allows you to have a strong alternative to Hormone Replacement Therapy (HRT) for the treatment of menopausal symptoms.^†

Better sleep is important:
Because menopause symptoms can rob you of good sleep, it's important to find a non-habit forming natural sleep support to help you greet each new day feeling refreshed!†

Why use Remifemin^® Good Night?

It provides time-tested, estrogen-free relief.
Remifemin^® provides effective relief for a 70% reduction of hot flashes, night sweats, irritability, mood swings and occasional sleeplessness and anxiety.^† In fact, over 15 clinical studies prove it's a safe and effective alternative to HRT for the treatment of menopausal symptoms, thanks to its completely estrogen-free RemiSure™ black cohosh.^†

It provides excellent sleep support, too^†
This formula combines the #1 OB/GYN recommended black cohosh extract with relaxing herbs, including valerian, lemon balm and hops.^† This herbal sleep blend provides 88% improvement in sleep, including falling asleep, staying asleep, quality of sleep and occasional restlessness.^† It's also non-habit forming and clinically shown to safely and gently support your body's own long-term sleep patterns.^†

Directions

Begin with one tablet at night with water. Depending on the severity of symptoms, you can increase your dose and take two tablets. Expect significant sleep improvement and menopausal symptom relief within a few weeks.^† Full benefits usually occur after 4-12 weeks of consistent use.

Interactions and Depletions

Technical Data

Description

Enzymatic Therapy Remifemin® Good Night is a unique nutritional supplement for the management of hot flashes, night sweats, and occasional sleeplessness associated with menopause.^† Remifemin Good Night features RemiSure^™ Black Cohosh (Cimicifuga racemosa) root and rhizome extract:

• Clinically proven to reduce hot flashes, night sweats, irritability, and mood swings associated with menopause^†
• Completely hormone-free, without plant-based estrogens that can affect breast and uterine cell growth

Enzymatic Therapy Remifemin® Good Night also provides a clinically studied Restful Sleep Blend of Valerian (Valeriana officinalis) root extract, Lemon Balm (Melissa officinalis) leaf extract and Hops (Humulus lupulus) strobile extract, which:

• Improves the quality of sleep in women with menopausal symptoms, which can cause occasional sleeplessness.^†
• Provides restful, refreshing sleep, with no morning grogginess, and no habit forming ingredients.^†
• Has an approved fixed combination monograph in the Complete German Commission E Therapeutic Guide to Herbal Medicines.¹




How Does It Work?


The safety and effectiveness of RemiSure black cohosh in Remifemin Good Night has been established from 50 years of rigorous and robust research, including clinical trials and open studies involving more than 1200 women.^† The sleep supportive herbal extracts in Remifemin Good Night have a long history of use that is backed by in-vitro and clinical research.

Remifemin Good Night Extract Ingredient	Vasomotor Symptom and Sleep Supportive Benefit Provided
RemiSure™ Black Cohosh (Cimicifuga racemosa) Root and Rhizome Extract	A randomized, double-blinded, parallel group study of perimenopausal and postmenopausal women who were treated with two different doses (39 mg and 127.3 mg) of RemiSure over a 24-week period. Efficacy and tolerability were determined by the Kupperman Menopause Index, Self-Rating Depression Scale (SDS), a global assessment of tolerability, adverse events, routine hematology, and biochemical tests. Assessment of vaginal cytology and measurement of reproductive hormones were end-points. The results demonstrated that both perimenopausal and postmenopausal women tolerated the treatment well regardless of dose (responder rate 70 percent and 72 percent, respectively). Menopausal symptoms were reduced 56 percent after four weeks of use, with a 70 percent reduction after 12 weeks.† No change in vaginal cytology was noted and no significant changes in reproductive hormones were detected. The study suggests that RemiSure is associated with improvement in menopause symptoms without estrogenic activity.†2
Valerian (Valeriana officinalis)	Valerian root extract has been studied in several clinical trials, repeatedly demonstrating improved sleep quality.† A placebo-controlled, crossover trial of 128 volunteers reported that valerian extract taken at bedtime decreased the time required to fall asleep and reduced the number of night awakenings.† 3 Another study using electroencephalograph (EEG) measurements as end-points demonstrated that use of valerian increased the time that subjects spent in restful and restorative sleep.†4
Lemon balm (Melissa officinalis)	Melissa officinalis has been studied for its support of healthy mood modulation.5 A recent double-blind, placebo-controlled, randomized, crossover study showed that taking standardized M. officinalis extract significantly increased self-ratings of calmness and reduced self-ratings of alertness.† 6
Hops (Humulus lupulus)	Hops extract has been studied for its ability to reduce restlessness and support restful sleep.† While hops extract has been used for centuries for gastrointestinal health support, it has recently been used to support healthy sleep.† 7 Hops and valerian have been found to work synergistically.8
Restful Sleep Blend Valerian (Valeriana officinalis) Root extract, Lemon Balm (Melissa officinalis) Leaf extract and Hops (Humulus lupulus) Cone	During a prospective 8-week observational cohort study the efficacy and safety of the ingredients in Restful Sleep Blend was investigated in 502 patients (n = 354 female; age: 53 ± 16 years) reporting occasional sleeplessness. The findings demonstrated an 88% improvement in the subject's ability to fall asleep, stay asleep, and in sleep quality (p < 0.001).† 9

Menopause
Menopause is a time of major hormonal, physical and psychological changes resulting in the cessation of a woman's menstrual cycles and the end of her fertility. During the years preceding menopause, estrogen and progesterone production slowly decreases, resulting in a number of uncomfortable symptoms. The most common and most disruptive of these symptoms are hot flashes and night sweats, the so-called vasomotor symptoms of menopause.^10,11 Research findings demonstrate that 75 percent of women between the ages of 35 and 62 experience vasomotor symptoms.¹¹

The exact cause of hot flashes and night sweats is unknown.^11,12 However, as there is no difference in the number, severity, or frequency of vasomotor symptoms in mid-life women with low levels of estrogen and those with normal amounts of estrogen, the amount of estrogen in the bloodstream is not a factor, at least not directly. ^10-12 One of estrogen's many functions is the suppression of a substance called luteinizing hormone (LH). When estrogen levels decline during menopause, high levels of LH are present in women's bloodstream. Studies have suggested that vasomotor symptoms are associated with high levels of this hormone. ^10-13

There have been numerous clinical and scientific studies of RemiSure^™ Black Cohosh in the relief of menopausal symptoms.^† The most recent (Osmers, et al; 2005) was a randomized, multicenter, double-blind clinical trial, that compared the efficacy and tolerability of RemiSure in the treatment of menopausal symptoms to placebo.^† A total of 304 women were randomly allocated to receive 40mg of RemiSure Black Cohosh or matching placebo daily for 12 weeks. The results showed that women in the RemiSuregroup experienced:

• Significant reductions of hot flashes after 2 weeks^†
• Up to a 70 percent reduction of symptoms after 12 weeks^†
• No significant side effects (the same as placebo - mild, temporary stomach upset) ¹⁴

Sleep
Many epidemiologic studies have linked interrupted sleep in menopausal women to night sweats. Recent research has indicated that menopausal status plays a minimal role in sleep quality and that other factors are involved, including occasional heartburn, nocturia (the need to urinate during sleep, bruixism (clenching and grinding of teeth while asleep), and weight gain. ^15-20

Sleep studies have demonstrated that symptoms of occasional sleeplessness in mid-life women include:


• Difficulty falling asleep (29%)
• Frequent wakening (21%)
• Daytime sleepiness (34%).16,21

Studies have suggested that decreased production of progesterone may also be a factor. Progesterone is the reproductive hormone required for conception, pregnancy, and childbirth. It also has a soporific, or sleep-inducing, property which explains why pregnant women who have high levels of progesterone in their bloodstream are often sleepy. This may also explain, at least in part, why menopausal women who have low levels of progesterone in their bloodstream experience occasional sleeplessness. ^22-24

In the large Freide study (2002) of the Restful Sleep Blend, sleep measurements and assessments were made with analog scales and psychometric methods at the onset of the study and established time intervals. After only two weeks of treatment, participants saw a 69% improvement in sleep measures.

Sleep component measured	Four weeks of treatment	Eight weeks of treatment
	Measured improvements (% of subjects)
Ease of falling asleep	89.7	94.0
Ability to stay asleep	88.8	95.7
	Reported improvements (% of subjects)
Quality of sleep	92.1	95.5

The quality of the subject's sleep was also judged by the investigators; their ratings were listed as "much better" and "very much better" in 62.6 percent of patients after 4 weeks of treatment and 77.3 percent after 8 weeks of treatment. ⁹

Compliance
Our Remifemin® Good Night has been developed to provide a full daily dose of RemiSure^™black cohosh and sleep components in one tablet taken at bedtime. Women should expect significant sleep improvement and menopausal symptom relief within a few weeks, with continual improvements over time.^†

Conclusion
Our Remifemin Good Night, a unique extract of black cohosh (Cimicifuga racemosa), valerian (Valeriana officinalis), lemon balm (Melissa officinalis), and hops (Humulus lupulus) safely and effectively reduces both the vasomotor symptoms of menopause and resulting occasional sleeplessness.^†



Recommendations


Begin with one tablet at night with water. Depending on the severity of symptoms, you can increase your dose and take two tablets. Expect significant sleep improvement and menopausal symptom relief within a few weeks.† Full benefits usually occur after 4-12 weeks of consistent use.



Precautions


Consult your healthcare practitioner prior to use if you have a history of liver disease or are taking prescription drugs. Do not use if pregnant, considering pregnancy, or nursing. For a few consumers, gastrointestinal discomfort or allergic reactions may occur but should not be persistent. If you observe these or other side effects, discontinue use and see your healthcare practitioner. May impair your ability to drive or operate heavy equipment. Due to additive sedative effect, avoid using with alcohol.



How Is It Supplied?



• 07480;21 Tablets
• 07487;7-Day Sample




Storage Recommendations


Store at controlled room temperature, 59°F to 86°F (15°-30°C).



References



1. Blumenthal M, Goldberg A, Brinckmann J., ed. Fixed combinations of valerian root, hops, and lemon balm. In: Herbal Medicine. Expanded Commission E Monographs. Austin, Tex: American Botanical Council; Integrative Medicine Communications; 2000: 304.
2. Liske E, Hanggi W, Henneicke-von Zepelin HH, Boblitz N, Wustenberg P, Rahlfs VW. Physiological investigation of a unique extract of black cohosh (Cimicifuga racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med. 2002;11:163-74.
3. Donath F, Quispe S, Diefenbach K, Maurer A, Fietze I, Roots I. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry. 2000;33:47-53.
4. Vonderheid-Guth B, Todorova A, Brattstrom A, Dimpfel W. Pharmacodynamic effects of valerian and hops extract combination (Ze 91019) on the quantitative-topographical EEG in healthy volunteers. Eur J Med Res. 2000;5:139-44.
5. Fleming T., ed. Lemon balm. In: PDR^® for Herbal Medicines. Montvale, NJ: Medical Economics Company; 2004: 502-503.
6. Kennedy DO, Wake G, Savelev S, et al. Modulation of mood and cognitive performance following acute administration of single doses of Melissa officinalis (Lemon balm) with human CNS nicotinic and muscarinic receptor-binding properties. Neuropsychopharmacology. 2003;28:1871-81.
7. Fleming T., ed. Hops. In: PDR^® for Herbal Medicines. Montvale, NJ: Medical Economics Company; 2004: 439-444.
8. 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;28:1465-71.
9. Friede M, Volk S, Laske A, Henneicke-von Zepelin HH, Freudenstein F. Clinical efficacy and drug safety of a phytosedative for the treatment of insomnia. Presented at the 16th Congress of the European Sleep Research Society, June 3-7, 2002.
10. Mehring PM. Menopause. In: Porth CM. Pathophysiology: Concepts of Altered Health States. 6th ed. Philadelphia, Pa: Lippincott; 2002: 991-993.
11. The North American Menopause Society (NAMS). Basic facts about menopause. Available at: http://www.menopause.org/edumaterials/guidebook/guidebook.htm. Accessed on February 12, 2006.
12. Mold JW, Roberts M, Aboshady HM. Prevalence and predictors of night sweats, day sweats, and hot flashes in older primary care patients: an OKPRN study. Ann Fam Med. 2004;2:391-7.
13. Kravitz HM, Janssen I, Santoro N, et al. Relationship of day-to-day reproductive hormone levels to sleep in midlife women. Arch Intern Med. 2005 Nov 14;165(20):2370-6.
14. Osmers R, Friede M, Liske E, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol. 2005;105:1074-83.
15. Hsu HC, Lin MH. Exploring quality of sleep and its related factors among menopausal women. J Nurs Res. 2005 Jun;13(2):153-64.
16. Lin TL, Ng SC, Chen YC, Hu SW, Chen GD. What affects the occurrence of nocturia more: menopause or age? Maturitas. 2005;50:71-7.
17. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47.
18. Driver HS, Baker FC. Menstrual factors in sleep. Sleep Med Rev. 1998;2:213-29.
19. Freedman RR. Hot flashes: behavioral treatments, mechanisms, and relation to sleep. Am J Med. 2005;118:124-30.
20. Moe KE. Hot flashes and sleep in women. Sleep Med Rev. 2004;8:487-97.
21. Soares CN. Insomnia in women: an overlooked epidemic? Arch Women Ment Health. 2005;8:205-13.
22. D'Ambrosio C, Stachenfeld NS, Pisani M, Mohsenin V. Sleep, breathing, and menopause: the effect of fluctuating estrogen and progesterone on sleep and breathing in women. Gend Med. 2005;2:238-45.
23. Landis CA, Moe KE. Sleep and menopause. Nurs Clin North Am. 2004;39:97-115. Review.
24. Soderpalm AH, Lindsey S, Purdy RH, Hauger R, Wit de H. Administration of progesterone produces mild sedative-like effects in men and women. Psychoneuroendocrinology. 2004;29:339-54.

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