| Criteria: |
|
Inclusion Criteria:
- Age 18-64
- Diagnosed with and under physicians care for osteoarthritis of the knee according
to American College of Rheumatology Criteria with radiographic evidence demonstrating
at least grade 1 OA
- Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme
pain imaginable)
- Meet DSM-IV and ICSD-R criteria for either primary (psychophysiologic) insomnia or
insomnia secondary to osteoarthritis
- Insomnia symptoms must include problems with middle of the night awakenings
- Insomnia symptom duration > 6 months
- Baseline, 2-week, sleep diary average wake after sleep onset time >30 minutes
- Baseline self-reported total sleep time < 6.5 hours per night
- Patients taking NSAID therapy for pain must be on a stable dose for a period of at
least one month prior to initiating the study
Exclusion Criteria:
- Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement
disorder, etc)
- Significant rheumatologic or chronic pain disorders other than osteoarthritis of the
knee, including fibromyalgia or the complaint of widespread pain impacting 4
quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
- Major medical disease (including, hepatic impairment, chronic obstructive pulmonary
disease/compromised respiratory function, cancer, dementia, diabetes, congestive
heart failure, cerebrovascular disease, raynaud’s syndrome)
- Active major psychiatric disorders (including dementia or cognitive impairment) and
history of schizophrenia or bipolar I disorder
- History of serious suicide attempt; 6) history of alcohol or substance (including
prescription medications) abuse
- Pregnancy or plans to become pregnant within 6 months
- Intraarticular steroid injection within the past month
- Regular (>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers,
within the past two months
- Regular (> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and
anticonvulsants within the past one month
- Unwilling or unable to discontinue all use of the medications listed in #10 for two
weeks prior to starting the study
- Unwilling or unable to discontinue all centrally acting agents and all analgesic
usage within 24 hours of pain testing sessions
- Refusal to provide consent to contact patient’s physician to establish diagnosis and
obtain medical record information
- Regular tobacco or nicotine use
- Heavy caffeine use [(>2 cups of coffee/day (equivalent)
- History of previous allergic reaction or severe side effects to sedative hypnotics
- Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin,
troleandomycin, ritonavir, nelfinavir)
- In addition, subjects will undergo in-laboratory blood tests prior to receiving drug
and will be excluded from further participation if they exhibit: a) positive
pregnancy test, b) positive toxicology (benzodiazepine, opioids, THC, alcohol, and
stimulants), c) abnormal liver enzyme panel |