The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Insomnia Sleep Studies, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2010 |
| End Date: | February 2014 |
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most
of the patients with fibromyalgia complain of either non-restorative sleep or complaints of
disturbed sleep due to pain. The proposed study is aimed at examining the effects of
milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,
double-blind, placebo controlled, two way crossover PSG study to explore the effects of
milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or
matching placebo.
of the patients with fibromyalgia complain of either non-restorative sleep or complaints of
disturbed sleep due to pain. The proposed study is aimed at examining the effects of
milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,
double-blind, placebo controlled, two way crossover PSG study to explore the effects of
milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or
matching placebo.
The sleep disturbance in fibromyalgia is characterized as non-restorative in nature, and is
defined as a feeling of light sleep, independent of duration, and as non-refreshing. As
such, these patients wake up in the morning and complain of stiffness and overall aching of
the body.
It is well known that reciprocal relationship exist between sleep and pain, with sleep
disturbances being an important contributor to morbidity in fibromyalgia. Milnacipran, a
selective serotonin norepinephrine receptor inhibitor (SNRI)), was approved by the FDA for
the management of fibromyalgia. Although milnacipran has extensively been studied in
fibromyalgia patients, but there is no objective measure, i.e., the use of overnight
polysomnography, to determine its effects on sleep.
The study is meant to explore the effects of milnacipran, versus placebo, on sleep in
patients with fibromyalgia as measured by overnight PSGs. The study will also involve
important domains of fibromyalgia etiology: sleep disturbance, pain, fatigue and quality of
life.
defined as a feeling of light sleep, independent of duration, and as non-refreshing. As
such, these patients wake up in the morning and complain of stiffness and overall aching of
the body.
It is well known that reciprocal relationship exist between sleep and pain, with sleep
disturbances being an important contributor to morbidity in fibromyalgia. Milnacipran, a
selective serotonin norepinephrine receptor inhibitor (SNRI)), was approved by the FDA for
the management of fibromyalgia. Although milnacipran has extensively been studied in
fibromyalgia patients, but there is no objective measure, i.e., the use of overnight
polysomnography, to determine its effects on sleep.
The study is meant to explore the effects of milnacipran, versus placebo, on sleep in
patients with fibromyalgia as measured by overnight PSGs. The study will also involve
important domains of fibromyalgia etiology: sleep disturbance, pain, fatigue and quality of
life.
Inclusion Criteria:
1. Men or women at least 18 years or older.
2. Diagnosis of fibromyalgia
3. Clinically significant sleep disturbance, defined as difficulty in maintaining sleep
(WASO, and AI) at least three times per week for at least one month.
4. Understand and willing to cooperate with the study procedures.
5. Maintain a normal sleep schedule, with daytime-awake and nighttime-sleep schedule,
with customary bedtime between 9 PM and midnight, and rise time 5 AM and 9 AM.
6. Patients who are able to speak, read, and understand English language, and able to
follow the study protocol, and are able to sign the informed consent.
Exclusion Criteria:
1. Subject has any of the following medical conditions:
• Liver disease; blood disorder, autoimmune disease, endocrine, cardiovascular,
hypertension, renal, hepatic, gastrointestinal, or neurological disorder; Active
peptic ulcer or inflammatory bowel disease.
2. Significant sleep apnea
3. Periodic Leg Movement or RLS
4. Any form of severe Psychiatric illness, moderate to severe depression, including
significant risk of suicide.
5. Patients with uncontrolled glaucoma.
6. Inability to discontinue the prohibited medications.
7. Female of childbearing potential not using birthcontrol measures; or lactating.
8. History of alcohol, narcotic, benzodiazepines, or other substance abuse within the
past one year.
9. Patient on prohibited Medication will include but not limited to:
- Anxiolytics, anti-convulsants, antipsychotics, lithium, barbiturates,
anti-histamines, monoamine oxidase inhibitors; or medications that affect sleep
- Any prescription or over the counter stimulants
- Medications that are contraindicated with the use of milnacipran
10. Excessive caffeine use, defined as a consumption of more than 500 mg of caffeine or
other xanthines, smoking >1/2 a pack/day, or alcohol use >14 units/week.
11. History of allergy to milnacipran.
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