Zaleplon in HIV Patients With Depression

An estimated >50% of HIV positive individuals report insomnia. Insomnia and other sleep
disturbances negatively impact outcomes in this population by contributing to metabolic
dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally,
in HIV depressed populations, insomnia may hinder remission from clinical depression. To
date, there have been no pharmacotherapeutic studies treating insomnia in this population,
emphasizing the need to determine whether known hypnotic medications work as effectively in
HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics
represent an attractive pharmacotherapy for treatment of insomnia in a depressed population,
as there are reduced side effects and abuse potential compared to classical benzodiazepines.
Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients
with comorbid depression warrants further study.

Inclusion Criteria:

1. Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive
HIV

2. Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance
with DSM-IV criteria, and receiving pharmacologic treatment.

3. Subject has obtained some subjective benefit from current antidepressant therapy and
is agreeable to remain on the same medication for the course of this study

4. Current symptoms of insomnia as determined by a total score of at least 2 on items 4,
5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset
latency of at least 1 hour, 3 or more times per week))

5. Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll
any patients who might require weaning off of sedative hypnotic medications in order
to be eligible for the study)

6. Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

1. Significant chronic, systemic illness or significant neurologic disorder, including
traumatic brain injury

2. Clinically significant history of liver disease

3. Psychiatrically unstable patients in the clinical judgment of the investigator as
indicated by current acute suicidality, current homicidal thoughts, or current
psychosis

4. Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness

5. History of substance abuse or dependence over the past 6 months

6. Currently taking medication to assist with sleep (e.g.,
Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam,
Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon,
Sonata/Zaleplon, Melatonin, Unisom, Benadryl).

7. Pregnant