Enhancing Hypnotic Medication Discontinuation in Primary Care

Inclusion criteria will be used to enroll individuals who are: (1) 18 years of age or older; (2) able to read and effectively communicate in English (without the use of a translator), as study resources are not available in other languages; (3) able to access reliable internet and a device with web-camera and Bluetooth capabilities that can be used for virtual study visits, study survey completion, digital insomnia intervention, and app-based activity tracking; (4) an established patient with a medical provider within a healthcare practice that has been trained on structured medication taper practices by our study group or able to confirm an established relationship with a prescribing provider and is willing to involve that provider if enrolled; (5) a history of extended (≥ 3 consecutive months) and frequent (≥3 nights/week on average) use of an eligible medication (see Appendix A); (6) a desire to decrease/eliminate hypnotic use; (7) a history of insomnia that meets DSM-560 criteria for insomnia disorder (as measured by the Structured Clinical Interview for DSM-5, SCID98); and (8) willingness to provide written informed consent to participate.

Exclusion criteria for this study include: (1) a lifetime diagnosis of any psychotic disorder, a lifetime diagnosis of a bipolar disorder, or suicide attempts within the last 3 years; (2) presence of an unstable, untreated, or terminal medical (e.g., serious neoplastic, cardiovascular, respiratory, liver, hematological, neurodegenerative, or infectious disorders that risk the subject well-being) or psychiatric condition or symptoms that would make participation unsafe or unfeasible (as assessed by initial screening and assessment and determined by the PI and/or medical monitor when indicated), with a full list of conditions and procedures available in the manual of operations; (3) imminent risk for suicide as evidenced by endorsement of suicide item on PHQ-9 followed by a moderate to high risk determination on Columbia Suicide Severity Rating Scale Screen; (4) history of a seizure disorder; (5) alcohol or drug abuse within the past year;(7) use of atypically high dosages of inclusionary BZD or NBZD hypnotic medications (i.e., ≥ 10mg of diazepam equivalents/night) if, after case review and/or further clinical evaluation, is deemed by study medical staff to be at high risk for serious adverse events by participating in this study; (8) pregnancy (per self-report); (9) significant cognitive impairment as suggested by a score of \<19 on the remote adaptation of the Montreal Cognitive Assessment (MoCA); (10) Current use of corticosteroids; (11) screening evidence (per Structured Clinical Interview for Sleep Disorders - Revised, SCISD-R and/or further screening by PI as needed) suggesting a current circadian rhythm disorder (e.g., delayed sleep phase type, advanced sleep phase type, shift work type, irregular-sleep wake type, non-24-hour-sleep-wake type) or other sleep disorder (i.e., narcolepsy, idiopathic hypersomnolence, REM behavior disorder, marked levels of excessive daytime sleepiness as a symptom of several potential underlying physiological sleep disorders) for which CBTI would not represent optimal therapy (12) care-taking responsibilities that cause sleep disruption;113 consuming \>2 alcoholic beverages/day ≥5 times/week. Prospective patients using alcohol specifically as a sleep aid, or alcohol after 7:00 pm more than once a week, will be required to discontinue this practice at least 1 week prior to enrollment/consent visit in order to be eligible to continue. These individuals will be asked to discontinue this practice for the remainder of the trial, although will not be removed from the study if they report use at later time points in the study.

Appendix A: Eligible Medications

* Zolpidem (Ambien, Ambien CR)
* Lorazepam (Ativan)
* Clonazepam (Klonopin)
* Eszopiclone (Lunesta)
* Temazepam (Restoril)
* Zaleplon (Sonata)
* Alprazolam (Xanax)
* Diazepam (Valium)
* Trazodone (Desyrel)
* Doxepin (Silenor)
* Quetiapine (Seroquel), ≤100mg only
* Mirtazapine (Remeron)
* Hydroxyzine (Vistaril)
* Doxepin (Silenor)
* Prazepam (Centrax)
* Flurazepam (Dalmane)
* Quazepam (Doral)
* Triazolam (Halcion)
* Cholordiazepoxide (Librium)
* Halazepam (Paxipam)
* Estazolam (Prosom)
* Oxazepam (Serax)
* Clorazepate (Tranxene)