Sequenced Therapies for Comorbid and Primary Insomnias

Inclusion Criteria:

- a complaint of persistent (i.e., > 1 month) difficulties initiating or maintaining
sleep despite adequate opportunity for sleep;

- a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights
per week during two weeks sleep diary monitoring;

- an Insomnia Severity Index (ISI) score > 10 indicating at least "mild" insomnia; and

- a score ≥ 2 on either the interference or distress item of the screening ISI,
indicating the insomnia causes significant distress or impairment in social,
occupational, or other areas of functioning. These criteria represent those provided
in the DSM-IV-TR87, Research Diagnostic Criteria3 and the International
Classification of Sleep Disorders4, and will ensure a sample with clinically relevant
insomnia.

Exclusion Criteria:

Exclusion criteria will be minimal to retain a broadly representative sample that includes
patients with primary and insomnia comorbid to a psychiatric disorder. Likewise,
individuals with a comorbid medical condition will be excluded only if the medical
condition is life-threatening or would contra-indicate using study medications. Exclusion
criteria are

- an untreated psychiatric disorder (e.g., major depression) as these conditions have
specific treatments and it would be inappropriate not to offer those treatments;

- a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction and
medications for insomnia may precipitate mania and hallucinations;

- an imminent risk for suicide;

- alcohol or drug abuse within the past year, since BzRAs are cross-tolerant with
alcohol;

- terminal or progressive physical illness (e.g., cancer, COPD), or neurological
degenerative disease (e.g., dementia);

- current use of medications known to cause insomnia (e.g., steroids);

- sleep apnea (apnea/hypopnea index > 15), restless legs syndrome, periodic limb
movement during sleep (PLMS with arousal > 15 per hour), or a circadian rhythm sleep
disorder (e.g., advanced sleep phase syndrome);

- habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM;

- consuming > 2 alcoholic beverages per day on a regular basis.

Individuals using sleep-aids (prescribed or over-the-counter) will be included if they are
willing and able to discontinue medications at least 2 weeks before baseline assessment.
Participants using alcohol as a sleep aid or alcohol after 7:00pm on a regular basis will
be required to discontinue this practice at least two weeks prior to baseline assessment.
Individuals using psychotropic medications (e.g., anxiolytics, antidepressants) will not
be automatically excluded from the study. Those on stable dosages (for at least three
months) of SSRI or SNRI medications and who show at least partial remission (via SCID)
from their mood or anxiety disorder will be accepted in the study if they meet the
selection criteria above. Patients using TCAs, MAOIs, or atypical antidepressants will be
excluded even if in remission as the effects of these medications on sleep might confound
interpretation of the findings. We will impose similar standards for those with MDD,
dysthymia, panic disorder, phobia, and GAD. We realize that some decisions about
enrollment may not always be easy to make, but we will rely on all available data and a
consensus approach to guide our clinical decision making process