ASCO Breast: Hot Flash Therapy Plus Hypnotic Improves Sleep in Breast Cancer Patients
WASHINGTON, Sept. 9 (MedPage Today) -- When hot flashes keep breast cancer patients awake, antidepressants augmented by zolpidem (Ambien) may bring more sleep time, suggested a small randomized trial reported here.
More than twice as many patients treated with zolpidem had improvement in objective measures of sleep time and quality, Hadine Joffe, M.D., of Massachusetts General Hospital in Boston, reported at the 2008 ASCO Breast Cancer Symposium.
Quality of life also improved significantly in the zolpidem versus placebo groups. Measures of hot flashes and mood did not differ between the treatment groups.
"Targeting sleep disturbance in breast cancer survivors with hot flashes may be an important strategy to optimize well-being," said Dr. Joffe. "Current approaches to treatment are only partially effective, which can lead to persistent sleep disturbance."
"Use of an agent like zolpidem is convenient in that it can be implemented at the same time as therapy for hot flashes without interrupting it," she added.
Selective serotonin reuptake inhibitors (SSRIs) and the dual reuptake inhibitor venlafaxine (Effexor) are widely used to treat hot flashes but provide only partial relief in a majority of patients, said Dr. Joffe.
To test the hypothesis that augmentation of antidepressant therapy with a hypnotic agent might improve hot flash management and improve sleep and quality of life, she and co-investigators randomized 53 breast cancer patients. Eligible patients had reported a minimum of 14 hot flashes over the previous two weeks and insomnia for at least one month, including three or more awakenings per night associated with hot flashes.
Patients already taking an SSRI or venlafaxine continued therapy, and those not taking one of the neurotransmitter reuptake inhibitors started treatment with venlafaxine XR at 75 mg/day. The patients were randomized to zolpidem at 10 mg/day or placebo and followed for five weeks.
Sleep quality was assessed by the Pittsburgh Sleep Quality Index and a wrist actigraph. Hot flashes were monitored by means of a patient diary and an electronic monitor worn at night.
The primary outcome was the proportion of patients who completed the study and had improvement in sleep quality (defined as at least a three-point decrease in the index) or a reduction in awake time after sleep onset (defined as at least a 15-minute improvement by the actigraph).
The principal secondary outcome was change in quality of life as assessed by a standardized instrument.
The patients' mean age was 51 and ranged from 30 to 65. Dr. Joffe reported that 89% of patients were postmenopausal (either natural or treatment-induced). In a third of cases, hot flashes were attributed to endocrine therapy, followed by natural menopause (28%), oophorectomy (23%), and chemotherapy (15%).
The patients averaged eight hot flashes per day, including two per night by the electronic monitor. At baseline their sleep quality score averaged 9, and awake time after sleep onset averaged 34 minutes.
Dr. Joffe reported that 23 of 25 (88%) patients randomized to zolpidem completed the study compared with 16 of 28 (57%) in the placebo group. Overall, 40% of the zolpidem patients versus 14% of placebo patients had sleep improvement by the end of the study (P=0.035).
Additionally, 60% of zolpidem patients who completed the study reported a reduction in awake time, as did all of 16 placebo patients who completed the study. However, objective assessment by actigraphy showed awake time decreased in 40% of the zolpidem group and none of the placebo patients.
An overall improvement in quality of life was documented in the zolpidem group, whereas the placebo group had an overall decline (P=0.01).
Primary source: 2008 Breast Cancer Symposium Source reference: Joffe H, et al "Effect of augmentation of venlafaxine and SSRI with zolpidem on sleep and quality of life in breast cancer patients with hot flashes: a randomized double-blind placebo-controlled trial" ASCO Breast 2008; Abstract 175.
What breastcancer.org says about this article…
ASCO Breast: Hot Flash Therapy Plus Hypnotic Improves Sleep in Breast Cancer Patients
Hot flashes usually cause sleep problems. The study reviewed suggests that a combination of an antidepressant medicine and Ambien (chemical name: zolpidem), a sleep medicine, may ease sleep problems caused by hot flashes more effectively than just taking an antidepressant.
The research was presented at the 2008 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium.
Breast cancer treatment can cause hot flashes, sometimes very suddenly. Chemotherapy and hormonal therapy medicines lower estrogen levels in the body or reduce estrogen's effects on the body, which is basically what happens during menopause. Younger women being treated for breast cancer may have to deal with hot flashes and other menopausal symptoms much earlier than usual. Hot flashes are also a symptom of naturally-occurring menopause, which may be happening around the same time as breast cancer diagnosis in older women.
Antidepressants are sometimes used to help women having severe hot flashes. There are two kinds of antidepressant medicines: SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors). Both were used in this study.
SSRIs include Paxil (chemical name: paroxetine), Prozac (chemical name: fluoxetine), and Zoloft (chemical name: sertraline). SNRIs include Effexor (chemical name: venlafaxine), Cymbalta (chemical name: duloxetine), and Pristiq (chemical name: desvenlafaxine).
In this very small study, 53 women diagnosed with breast cancer all had:
- at least 14 hot flashes during the 2 weeks before starting in the study
- trouble sleeping for at least a month before starting in the study (waking up 3 or more times each night because of hot flashes)
All of the women were treated with either one of the SSRI antidepressant medicines or the SNRI antidepressant Effexor. About half of the women also took Ambien. The other half of the women took a placebo (sugar pill) along with the antidepressant.
The women kept track of hot flashes, quality of sleep, sleep disruptions, and overall quality of life. The women's sleep and wake times were measured by a sleep monitor (actigraph) attached to the wrist.
Among the women who completed the study:
- 40% of the women who took Ambien and an antidepressant had some improvement in sleep by the end of the study compared to 14% of the women who took a placebo and an antidepressant
- time awake at night (measured by the sleep monitor) was reduced by 40% in women who took Ambien and an antidepressant but didn't change at all in women who took a placebo and an antidepressant
- overall quality of life improved during the study for women taking an antidepressant and Ambien but actually declined in women taking a placebo and an antidepressant
If you're having hot flashes and are considering treatment or have taken an antidepressant that didn't help, you might want to talk to your doctor about the results of this study. Together you and your doctor can decide if adding a sleeping medicine such as Ambien to your treatment plan makes sense for you.
It's important to note that the women in this study had frequent, severe hot flashes that dramatically disrupted their sleep. For many women with less frequent and less severe hot flashes some diet and lifestyle changes can help:
- yoga
- massage
- meditation
- low-fat diet
- avoiding caffeine, alcohol and cigarettes
You can read more about approaches to help ease hot flashes on the Breastcancer.org All About Hot Flashes page.